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    Health & Fitness

    Journal of Clinical Oncology (JCO) Podcast

    The Journal of Clinical Oncology Podcast presents analyses and discussions centered on the latest findings published in ASCO’s flagship Journal of Clinical Oncology. Host Dr. Davide Soldato facilitates interviews and scholarly discourse on the most impactful published findings. The Journal of Clinical Oncology Podcast is the trusted resource that empowers you to integrate cutting-edge evidence into clinical practice.

    The year’s fellows interview authors and summarize the top Journal of Clinical Oncology articles in the series, JCO Article Insights.

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    Copyright: © Copyright by the American Society of Clinical Oncology

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    Latest Episodes:
    Intersectional Maxims for a New Era in Modern Medicine Dec 09, 2022
    Show notes

    Dr. Shannon Westin and Dr. Stephanie Graff discuss a revision to the famous "Simone's Maxims" and the broader nature of intersectionality. TRANSCRIPT The guest on this podcast episode has no disclosures to declare. Dr. Shannon Westin: Hello, everyone, and welcome to another episode of JCO After Hours, where we get in-depth on articles that have been published in the Journal of Clinical Oncology. I am your host, Shannon Westin, a GYN Oncologist, and Professor at MD Anderson Cancer Center, and I'm honored to serve as the Social Media Editor of the Journal of Clinical Oncology. Today, we're going to be discussing the very important work called "Understanding Modern Medical Centers: Beyond Simone—Intersectional Maxims for a New Era." And this was published online in the JCO on September 27th, 2022. And joining me to discuss this important work is Dr. Stephanie Graff, who is the Director of Breast Oncology at the Lifespan Cancer Institute at the Warren Alpert Medical School, Brown University. Welcome, Dr. Graff. Dr. Stephanie Graff: Thanks so much for having me. It's going to be fun to talk about this piece with everyone. Dr. Shannon Westin: Yeah. It's a great piece of work. And before we start, I will just note that all participants have noted no conflict of interest for this manuscript. So, let's get down to it. I want to level set. What were Simone's Maxims, that you just revised, and why did they matter? Dr. Stephanie Graff: Yeah. So, Dr. Joseph Simone, who is a legend in oncology, and our revision of his work is truly in respect of what he did, not in any way meant to be anything less than that. So, in 1999, Dr. Simone published, in Clinical Cancer Research, this piece that would famously come to be known as Simone's Maxims, and the official title was, "Understanding Academic Medical Centers." And that list of, you know, sayings and circulated truths have really sort of been this commonly quoted list of things that people talk about in medicine as just the truth of what it takes to sort of cut it, if you will, in the world, especially in academic medicine, but just medicine in general. Like, one of the famous ones is "Institutions don't love you back." And I think that you've probably heard these and maybe not even realized that you were quoting or hearing Simone's Maxims, but they're pretty ubiquitous in the world of academic medicine and, in particular, oncology, because Joseph Simone was an oncologist. He actually went on to write a book. There's a text called Simone's Maxims as well that's much longer than the Clinical Cancer Research piece. We didn't have a book in us yet, so we just started with updating the original manuscript. Dr. Shannon Westin: That's so great. And it's so funny when I was younger--I don't know if I'm still young or not, but there was things that we said, and I had no idea where they came from. So, I bet that a lot of our listeners are saying the same things, like, "Oh, that's a Simone's Maxim." So, I guess the question is now why did your group set out to update these? Dr. Stephanie Graff: I think if you look at the list of authors, a bunch of the authors have had recent career changes. And so, it actually started as just sort of this casual conversation about how for many of us who have recently undergone career changes, that some of these maxims don't hold true for us. The list of authors is a group of very intersectional physicians in our identities--and I know you'll ask me a question in a moment here about what exactly intersectional means. But, you know, I think that Dr. Simone wrote Simone's Maxims at a time when Medicine was more homogeneous, and so, some of the Maxims that he wrote represent the more traditional values of medicine, what medicine looked like in 1980, in 1990. And I think medicine in 2022, 2023, 2033 is just continuing to evolve and change shape. And so, it's important that we reframe the truths of what it takes to foster a successful career, create successful working environments for the modern workforce. Dr. Shannon Westin: I think this is so critical, and we're seeing it across a number of different fields, not just medicine. We're seeing it in politics and policy and other places. So, why don't you just make sure that all our listeners do understand this concept of intersectionality and how it applies, you know, in medicine and feminism and other areas? Dr. Stephanie Graff: Yeah. And that--shout out to our co-author Edith Mitchell. Dr. Mitchell very quickly said, "Well, we have to start the manuscript by defining intersectionality if we're going to include it in the title because a lot of the readers won't even be familiar with the concept of intersectionality." So, it's included there in the maxims. Intersectionality was first introduced in 1989, and the definition is this nature of social categories, like race and class and sex and gender and the way that they overlap, so that I'm not just white or Christian or a farmer's daughter or a woman, but I'm all those different things, and that creates my intersectional identity. And obviously, there are millions of different intersectional identities, because we have all of these different facets of our personality, of our identity, that come together. And as medicine gets more diverse, which I believe makes us stronger, we'll see more and more complexity in the intersectional personalities, intersectional identities, of the people working in healthcare. Dr. Shannon Westin: Thank you. I couldn't have said it better myself. You know, the other question that comes up as we start seeing more diversity in our workforce, and I mean, frankly, in our patient population, how do you think that that understanding about diversity and the accentuation of our diversity helps improve the success of medical organizations? Dr. Stephanie Graff: Oh, gosh. There's like a million examples. I think that-- ah, Shannon, there's so many different examples I can quote. So, I think that you know, there's a study that looked at patients coming into the emergency department having heart attacks. And if they were female patients cared for by female doctors or female patients cared for by male doctors, that had an impact on their risk of death. Not surprisingly, it was the women patients cared for by male doctors that were the most likely to die and the female patients cared for by the female doctors that were the most likely to live, telling us that when there's this concordance, this understanding between patient and physician, that it improves outcome. But that could be corrected if the male physicians had more female partners. So, just that understanding of relationships, that exposure to more people, more female physicians, increased male physicians' ability to care for female patients or communicate with female patients, it just increased confidence, our collective confidence. And that's been proven in other settings too. But that's just one sort of great example. The McKinsey group has shown how financial performance improves with gender diversity and ethnic diversity. And that's been shown, not just in healthcare, but in numerous different business environments. And if we think about, you know, as an oncologist, as a clinical researcher, if I imagine that innovation is improved by diversity, imagine that translating into better clinical trial outcomes with a more diverse workforce. And the outcomes that the McKinsey group show, ethnic diversity drove a 35% improvement in financial performance, which is huge. And again, that's at a time when the oncology workforce is really struggling with everything from, you know, recruitment to trials, staffing, revenues. That would be enormous if we could derive that sort of performance. So, I think that there's a million different ways to illustrate what diversity could do, whether it's make us better or stronger or more confident or provide better care, and it's been shown in a million different ways, in a million different contexts. Dr. Shannon Westin: Well, you're convincing everyone, I know. I think we'll get into some of the kind of more nitty-gritty details of the manuscript. I want to be very clear; I think all our listeners should absolutely 100% read the entire manuscript because it's so critical. But let's try to hit some of the major high points. And I say this all the time, and I'm going to take your line, but which one's your favorite? What do you think is the most important one? Just like you would totally tell me which of your children is your favorite, right? Dr. Stephanie Graff: I can't possibly pick a favorite. That's completely impossible. I really like--one of the Maxims that we have is, "Everyone's time and voice is valuable. Institutional leaders must respect time and encourage diversity of thought." Originally, Dr. Simone had a maxim that said, "Members of most institutional committees consist of about 30% of people who work despite other pressures and 20% who are idiots, status seekers, and troublemakers." And we changed that to say, again, "Everyone's time and voice is valuable. Institutional leaders must respect time and encourage diversity of thought," as a way of saying that, you know, I think that in 2022 and beyond, we're getting to a place where it's important that we find better labels for people than idiot and troublemaker and that we reach beyond that to identify how we can help everyone find an environment to be successful and that we fill the working corners of our cancer centers, the working corners of our hospitals, healthcare systems, clinics, with the people that are excited about the work that needs to be done. And, you know, not all of us are gonna want to run clinical trials. Not all of us are going to want to do quality improvement projects. Not all of us are going to want to do five straight days of clinic. Not all of us are going to want to do--insert the day-to-day grind of whatever it is that needs to get done to make a cancer center function. But somebody somewhere loves that little thing. And it's important that we work together to accomplish what needs to be done for best care of the patients that we're honored to take care of. And so, we have to respect that time, respect that voice, and work to connect people with the thing that drives them. Dr. Shannon Westin: I think that one, how you just ended there, kind of touches on one of the ones that really grabbed my attention, which was the original maxim that was, "Leaders are often chosen primarily for characteristics that have little or no correlation with successful tenure as a leader." And instead, as an intersectional maxim, you all changed it to, "Leaders should be chosen for their ability to inspire." That really spoke to me because it's exactly what you said. That leader has to work to inspire people to do what they love within each piece of that, you know, department or division or hospital or organization or whatever. You can't expect everybody to do the same cookie-cutter thing, but help inspire people to be behind the mission and do what they love as part of moving that hospital organization forward. I thought that was really perfect. Dr. Stephanie Graff: Yeah. And we've too often seen, you know, in academic medicine especially, that we equate a really high h-index or a really successful history of grant funding with leadership. And those aren't the same skills, right? Like, you could be a really fantastic researcher and not a really great person at organizing a team of people to run a cancer center. And you might have both skills, in which case, wow, congratulations. But I think that it's important that we look at the job in front of us and select for that, rather than assuming that all of the same skills fill every single job because that's just not true. Dr. Shannon Westin: I think that, again, I know I said this already, listeners, but please, please run, don't walk, to read the whole paper and get more information. On our last note, one of the things I really loved about this paper was you really provided some clear reforms really to help improve physician wellness. Can you maybe summarize some of those reforms that could improve intersectionality within healthcare organizations? Dr. Stephanie Graff: Yeah. Those are all in Table 2. So, again, I hope you guys all grab the paper and give it a download and pin them up somewhere and think about them. I think that some examples are, you know, to really promote intersectionality, which means that you've got a lot of diversity in characteristics across your cancer center, which is going to be things like gender, race, introverts, extroverts, researchers, clinicians. You really have to have very clear metrics that are shared and discussed. And so, you might need to publish benchmarks for things like median RVUs or come up with a group incentive structure, so that whether you're a person who is in clinic less and publishing more or in clinic all the time and publishing less, you can work together to be flexible collectively, and then everybody can be contributing to that greater team environment. I think it's really important that if you want to grow intersectionality, that your search committees and your leadership interview strategy undergoes unconscious bias training. There's still not really great strategies to make sure that we're 100% pursuing a no-bias environment in our workplace, but there is evidence that unconscious bias training can be effective to help us recruit a more diverse workforce. And that's the simplest strategy - is if you're going to be putting a search committee together, have everybody do an implicit bias training and work together to select candidates that don't necessarily fit what feels like your traditional mold, and then find strategies, once you've hired into your organization, to partner your new employee, new physician, new hire, for maximum success in that workplace. Another important thing is, as you're growing diversity in your organization, is to make sure that you're creating opportunities to give everybody a voice. You should be looking at who's being invited to speak and making sure that that's representative and diverse. You should be considering changing up strategies. One of the examples I often give is that, when we have a problem and we do brainstorming, where you bring everybody in a room and they shout out, "This is what I think we should do," what happens is you get the loudest extrovert or the most powerful person at the table who just gets their way. And it's far more effective to do brain writing, where you have everybody write down the three or five or 10 things that they think might work, and then you read those out in a neutral way, because then, everybody's voice and everybody's idea gets equal play in a neutral way that allows you to elevate those ideas independent of the other bizarre, irrelevant hierarchies that may exist in your system and can really elevate some of those diverse voices and ideas in your organization. Those are just some of the examples that are listed. Dr. Shannon Westin: Yeah. Listeners, there's a ton of very clear frameworks that you could potentially implement tomorrow in your organization if you want to strive to improve the intersectionality. Well, the time always goes so fast. It has been so great to speak with you, Dr. Graff. Thank you so much for being here. Dr. Stephanie Graff: It's su…

    Full show notes at the publisher

    Does Medicare Advantage Lead to a Disadvantage for Patients Who Need Surgery for Cancer? Nov 21, 2022
    Show notes

    Dr. Shannon Westin and Dr. Mustafa Raoof discuss the paper "Medicare Advantage: A Disadvantage for Complex Cancer Surgery Patients."

    TRANSCRIPT

    Dr. Shannon Westin: Well, hello, everyone, and welcome back to another episode of the JCO After Hours podcast, where we get in-depth on articles that have been published in the JCO.

    I am your host Shannon Westin, and it is my pleasure to serve as the Social Media Editor for the Journal of Clinical Oncology, as well as a Professor in GYN Oncology at The MD Anderson Cancer Center in Houston.

    And today, I am very excited to be discussing a paper that was recently published in the JCO called "Medicare Advantage: A Disadvantage for Complex Cancer Surgery Patients." And I am accompanied today by Dr. Mustafa Raoof, and he has no conflicts of interest to disclose. He is an Assistant Professor in the division of Surgical Oncology, Department of Surgery, and an Assistant Professor in the Department of Cancer Genetics and Epigenetics at the City of Hope Cancer Center. And there, he is a Surgical Oncologist with expertise in hepatobiliary and pancreatic cancer, and I'm thrilled to have him here today.

    Welcome, Dr. Raoof.

    Dr. Mustafa Raoof: Thank you. It's a pleasure to be here. Thank you for inviting me.

    Dr. Shannon Westin: Of course. And thank you for your incredible work. We're going to get right to it. This is, I think, a really timely and important paper because I think we are always trying to understand how the insurance coverage or the medical coverage that our patients have here in the United States impacts their overall quality of care.

    So, first, let's level set for the audience. Can you describe the basics of Medicare Advantage, which is what you explored in this paper, and how common is this coverage in the United States?

    Dr. Mustafa Raoof: So, Medicare Advantage is the privatized aspect of Medicare, and what we know is that since the 1970s there were some private plans that were part of Medicare. But really at the turn of the century, 2000 and onwards, Medicare Advantage has gained a lot of popularity. And this is where the government basically pays a lump sum cost for a beneficiary to private insurance companies to manage Medicare. And so, it's a privatized product. And the idea there is that it's supposed to be an all-encompassing product for the beneficiaries, and the biggest advantage, initially at least, was that there was an out-of-pocket maximum, so patients are not subjected to extreme financial stresses.

    The cost that was paid to Medicare Advantage plans per beneficiary were in the order of somewhere between 800 and $900 per beneficiary, per year. This was a little bit higher than what would have been the cost to Medicare, but that was to gain a lot of momentum into getting the private insurance interested in the plan. And then subsequently into that, there were a lot of incentives that were set for these Medicare Advantage plans based on some measures of quality, to kind of incentivize the quality products from this private insurance. And so, that's kind of the lay of the land for what the Medicare Advantage plans are.

    Now, in terms of, how popular are they? I think this has grown significantly over the last 10 years, especially, 46% of all Medicare beneficiaries nationally are part of this Medicare Advantage plan, and it's not one plan, every private insurance company has their own offerings. But a significant majority, I think it's estimated that more than half, and even, you know, going beyond 10 years, the majority of Americans will be insured by these Medicare Advantage plans.

    Dr. Shannon Westin: That's incredible, and certainly, that means this work that you did has such great impact with the number of patients that are going to be impacted. Can you give the listeners a little bit of an idea of how Medicare Advantage coverage might differ a little bit from the traditional? I know you mentioned the out-of-pocket costs, and that it's run by different companies, but any other kind of discerning features?

    Dr. Mustafa Raoof: Yeah. So, with the Medicare Advantage plans, as I mentioned, you know, there's an out-of-pocket maximum. In addition, vision and dental plans, as well as gym memberships are included as part of the plan, to kind of provide a holistic plan to the older Americans. And then, one of the things that kind of stands out is that what is the downside to Medicare Advantage plans from a company that is providing this kind of a product, and so, they have to cut costs somewhere. So, I think the main downside to patients would be that their options, in terms of specialist care, will be limited because the networks are generally narrower. There is a variability in different plans as to how big and small their networks are, but they could be more restrictive, and if a potential beneficiary is not aware of that, they could lose out on seeing some doctors that they would've otherwise wanted to see.

    Dr. Shannon Westin: Okay. That totally makes sense. And so, I guess the next natural question is, what led you to explore the impact of this coverage Medicare Advantage on patient outcomes in surgical practice?

    Dr. Mustafa Raoof: Yeah. So, as somebody who sees patients with advanced cancer, I think a lot of Medicare Advantage beneficiaries are caught by surprise at the time when they're seeking out care, and they think that they have Medicare, and they should be able to seek whatever care that they would like. Whereas, you know, when they contact their provider, they're told that they have to go to a certain doctor in a certain network. And the shock that this is, as a secondary shock, in addition to the shock of a cancer diagnosis and needing a surgical intervention. So, early on in my training, I had seen some of that, and, you know, I really wanted to delve deeper into helper based problems, is: does it even matter if they go with different specialists, as long as there is some quality to that? And so, I started looking into the quality of the Medicare Advantage network from there on.

    Dr. Shannon Westin: That leads us directly into your study. Why don't you give us a rundown of the design, and how you wanted to achieve those objectives that you just discussed?

    Dr. Mustafa Raoof: So, leading up to the study, we had a publication in Annals of Surgery that looked at what do the networks look like for these Medicare Advantage plans. And that kind of information is hard to find. As you could tell, a lot of patients don't even know if a certain hospital will be covered by their insurance. And so, through a collaboration with Gretchen Jacobsen who studies this as well, they had compiled data on the networks for different hospitals, and for different plans in LA County, as to which hospitals were covered. So, we looked at that, and we found that a lot of these Medicare Advantage plans don't have access to high-volume hospitals, which was our way of measuring quality. And so, that kind of set the tone for this, and then we wanted to ask if there is a difference in outcome between patients who are insured by Medicare Advantage versus those who are insured by traditional Medicare.

    Medicare Advantage data has been a little bit tricky to obtain for a lot of folks that I think it wasn't released because of data quality issues. We were a little bit lucky, in that we had access to the California Cancer Registry dataset, which includes all patients diagnosed with cancer in California, and that data was linked to discharge data from inpatient hospitalizations. And so, one of the categories that is collected is patients' insurance, whether it's Medicare or not, and whether it's managed or not. So, with that, we thought it was the perfect opportunity to ask a very simple question, and that question is, what are the differences in terms of access to high-volume surgery or quality cancer surgery, and what are the impacts on the outcome for the two different kinds of insurance plans?

    So, the design is a retrospective cohort analysis, and we included all patients who were undergoing elective inpatient cancer surgery. We selected some index cancers, and we realized that it's not comprehensive, but we wanted to give it a go with some of the more common cancer diagnoses. So, we included lung, colon, and rectal, and then we also included some high complexity operations such as esophagus, stomach, pancreas, and liver, and we included all data from 2000 to 2020. And in terms of the primary objective of the study, we wanted to look at hospital mortality, so we looked at the association between 30-day hospital mortality, but we also looked at complications, readmissions, and failure to rescue. One of the other objectives of this study was to look at the association between insurance stipend, access to care-- we defined access to care in several different ways. Because there's no singular definition, we said access to care would be somebody getting access to cancer surgery at a Commission on Cancer-designated hospital, or NCI-designated cancer center, or a high-volume hospital, as defined by other authors previously, or a teaching hospital. So, we used several different definitions to kind of see if there is association between insurance and patients' access to care.

    Dr. Shannon Westin: And let's hear it. What were the results? How did Medicare Advantage compare to traditional Medicare?

    Dr. Mustafa Raoof: Given our previous work on MA networks data, this was not a surprise, but when we saw that for all of the cancers that we looked at, there were significant barriers to access, in terms of getting to an NCI-designated cancer center, or a high-volume cancer center. So, no matter how we looked at it, we felt that there was a significant disparity in getting to these specialist hospitals, which we associate with quality of cancer surgery. But what was interesting in a major finding of the paper was that for certain cancers, for example, gastrectomy, pancreatectomy, and hepatectomy, we found significantly increased early-day mortality for those operations. And so, for example, for gastrectomy, there was 1.4-fold higher mortality, for pancreatectomy 1.9-fold, and then for hepatectomy, 1.4-fold. So, these are tangible figures in-- you know, the idea is that if somehow we can improve access to high-quality surgery within MA plans, to match that of traditional Medicare, which is not ideal still, but I think just by doing that, we could impact, potentially reduce cancer deaths from surgery itself.

    Dr. Shannon Westin: So, I was struck by the fact that there was a difference between the outcomes you mentioned - stomach, pancreatic, liver surgery, and colon cancer. You know, why do you think there might be a difference?

    Dr. Mustafa Raoof: That's a great question. So, I think colon cancer surgery has-- I wouldn't say it is low-complexity, but it's intermediate-complexity. And I think as a surgical workforce, a lot of surgeons who may or may not be trained with fellowship specialization, they are able to do a really good job of colon resection, and so, there are many high-volume surgeons that do not actually sit in NCI-designated cancer centers or CoC-accredited hospitals, and they're doing a really good job. And so, I think we see that the impact of access is less in colon surgery, and I think that may explain why that is.

    Dr. Shannon Westin: We've looked at this, and I know you said that you picked some common cancers, and I know you did that because, you know, I'm a GYN Oncologist, so I was definitely interested in outcomes here. We definitely see that, in especially ovarian cancer surgery, which is rare, is that high-volume centers matter. And it can be a comprehensive cancer center, or it can just be a really high-volume center that draws a lot of ovarian cancer, it doesn't necessarily have to be a cancer center. So, that certainly makes a lot of sense. I guess the next question really is what happens next for this work? Like, what can we do to make a difference here?

    Dr. Mustafa Raoof: So, just reading the landscape on health insurance, I think there's significant incentives for Medicare Advantage plans. So, I think that is going to exist, and I think that will be in the future. I think the important aspect will be to ensure the quality of Medicare Advantage plans. And I think the data that is presented in this study, we hope that it will shed some light, and give a voice to patients who are dealing with a situation where they need complex cancer surgery. And we also hope that there would be some transparency when patients are signing up for the insurance plans, they should be able to say, "Okay, well, with the Medicare Advantage plan, we are getting this quality of cardiac care, this quality of cancer surgical care", and I think that should be an important component. You know, some Medicare Advantage plans may excel in one aspect of care, for example, you know, Alzheimer's care or cardiac care, but may do poorly in cancer surgery care, or cancer care in general. So, I think those are some of the things that the policymakers will need to balance and incentivize.

    Medicare Advantage plans are really great at cutting utilization because they manage healthcare effectively, but it does introduce some sort of inefficiencies in the system where everything requires a prior authorization; a lot of physicians are familiar with that - a patient needs life-saving surgery, and the authorization is nowhere to be found for two, three weeks, four weeks, and that's a really difficult problem for the patient to go through, and their caregivers. It's a difficult time for them. So, I think those inefficiencies can be mitigated as long as those who require cancer surgery are seen as a distinct population who need timely access to high-volume surgery. I think modifying MA plans in a better way to reflect that, will be the future.

    Dr. Shannon Westin: Yeah. We've seen this come up on the podcast multiple times as we're talking about inequities and quality of care. You know, it's on us as physicians and practitioners to interact with our policymakers. We've not always been really good at that, but I think this type of work that you've done really helps us have that objective data that we can bring to these policymakers so this change can be enacted.

    Well, thank you so much, Dr. Raoof. We really appreciate you taking the time being on the podcast.

    And again, for our listeners, this was a discussion of "Medicare Advantage: A Disadvantage for Complex Cancer Surgery Patients," and we were with the first author, Dr. Mustafa Raoof. Please make sure you check it out, and please feel free to check out our other podcasts on the JCO website.

    Until next time, this has been Shannon Westin, with JCO After Hours. Have a great day.

    The purpose of this podcast is to educate and to inform. This is not a substitute for professional medical care and is not intended for use in the diagnosis or treatment of individual conditions.

    Guests on this podcast express their own opinions, experience, and conclusions. Guest statements on the podcast do not express the opinions of ASCO. The mention of any product, service, organization, activity, or therapy, should not be construed as an ASCO endorsement.


    Lack of Gender Equity in Oncology Clinical Trial Advisory Board Membership Nov 03, 2022
    Show notes

    Shannon Westin, Pamela Kunz, and Rachna Shroff discuss the lack of gender equity on oncology industry advisory boards. TRANSCRIPT The guest on this podcast episode has no disclosures to declare. Dr. Shannon Westin: Hello, everyone, and welcome to another episode of the JCO After Hours podcast; our podcast where we get in-depth for articles in the Journal of Clinical Oncology. I am your fearless leader, and host, Shannon Westin, the Social Media Editor for the JCO, as well as a Professor of Gynecologic Oncology at MD Anderson Cancer Center. And I am so excited to introduce our two guests today. We are going to be discussing the article from the JCO, 'Where Are All the Women in Industry Advisory Boards?' And none of my guests have Conflict of Interest related to this work. So, first, let me introduce Dr. Rachna Shroff, she is from the University of Arizona, Tucson. She's not only the Interim Chief of the Division of Hematology/Oncology, she's the Associate Dean of Clinical and Translational Research, and Associate Professor of Medicine, the Chief of the Section of GI Medical Oncology, and the leader of the GI Clinical Research team. And somehow, we got her on this podcast. I don't know how she had the time. Welcome. Dr. Rachna Shroff: Thank you. So excited to be here. Dr. Shannon Westin: She is the first author on this paper, and she's also accompanied by the last author on this paper, Dr. Pamela Kunz, from the Yale School of Medicine, where she serves as Associate Professor of Internal Medicine, the Director of the Center for Gastrointestinal Cancers at Smilow Cancer Hospital, and Yale Cancer Center, the Chief of GI Medical Oncology, and the Vice Chief of Diversity, Equity, and Inclusion in Medical Oncology. Welcome. Dr. Pamela Kunz: Thank you. Really excited for this. Dr. Shannon Westin: I have to step up my game, man. This is an esteemed panel here. So, we're going to get right to it. I think this is such an important topic because you know, we've been seeing quite a bit of focus on gender equity in Oncology, I would say, really over the last five years, really, especially - yay. Where do you all see the biggest gaps? Like, what are we missing? What do we need to do? Dr. Rachna Shroff: Well, I'm happy to chime in, and I know that Dr. Kunz has her thoughts as well, but I agree with you. I think the first step to trying to address these gaps is just opening the conversation, and I think we have made tremendous strides in that regard. In terms of gaps, I mean, half of the reason that we even started thinking about this topic was really related to research, and opportunities for clinical trials, clinical research, drug development, and where women can try to increase their visibility and their opportunities. And the honest truth is, some of these things we see day-to-day when we see the number of women at the podium presenting pivotal trials, and the number of women that are lead authors on practice-changing papers. And that, I think, is really an area that needs to be talked about. And then, we need to work on the opportunities for solving these problems and coming up with solutions with everybody around the table, all of the key stakeholders engaged. Dr. Pamela Kunz: I completely agree. And you know, I think that because Dr. Shroff and I are both in the clinical trials space, you know, she and I have talked about this, and I think that industry-sponsored clinical trials are certainly one space, national clinical trial network trials are another space that we are also trying to move the needle, and I think that we really all have a collective responsibility in whatever we're doing to really try to ensure equity and representation, both of women, but also underrepresented minorities. And I think that the way I really like to personally think about this is, as Dr. Shroff said, if we can diversify the people who are leading the science, whether it's clinical trials, basic or translational, our science will in fact be better. We will ask more innovative, creative questions, and our patients will benefit from it. We will have more, I think, health equity because different people will be thinking about how to do the science. So, it's really critical and I think it's something that it is really exciting. I agree with you, Dr. Weston, that it's, "Yay," that we're having some recognition of this. And I think really step one is collecting data, benchmarking, figuring how we can do better. Dr. Shannon Westin: Yes. And I think that's a really nice segue to get into kind of what led you to explore this current area of focus around advisory board participation, and why that matters Dr. Pamela Kunz: Dr. Shroff, should I tell the story? Dr. Rachna Shroff: I was going to say, "Should we share our story?" Dr. Shannon Westin: Oh, I love a story. Yeah, definitely. Dr. Pamela Kunz: Oh, it's a good story. It's a good story. It involves Dr. Brian Alexander, who is one of our co-authors in this and is at Foundation. So, I was invited to participate in a Foundation Advisory Board, this was now, probably two years ago. And I have, as a practice, I now ask, "Who else is on the Advisory Board, and who is chairing the Advisory Board?" Because I've ended up, as I'm sure Dr. Shroff has as well, on advisory boards where I'm the only woman. And so, I've just as a policy, tried asking, and then I will also nudge if I notice that there's not great representation of women. And so, this was one of those times, and there were no other women advisors invited, and I objectively had a conflict, so I could not attend. And this was before I even knew Brian. I was like, "I'm going to email the CEO and the COO of Foundation." And I did, and immediately got a response. And in fact, really to Dr. Alexander's credit, he called me the next day and said, "We can't let this happen. How can we be part of the solution? We have some other fantastic industry partners intentionally as part of this author list, and I think we're really eager to try to partner in this. I think it takes an academic-industry partnership to try to move the needle here." So, I think it took some real vulnerability on Dr. Alexander's part to say, "We need to do better and to really do a deep dive." Dr. Shroff, any comments on that? And then you and I started texting, I think. Dr. Rachna Shroff: Yeah, No. So, similarly, I was asked to participate in I think, the same advisory board, but I also had a conflict, which is why Dr. Kunz did not see that I was one of the invitees. And so, that's how we started talking about it. And I agree. I think what was truly admirable was, of course, not just the immediate responsiveness, but the, "Let us be part of the solution." Like, "What can we do intentionally to try to shine a light on this?" And then, "What can we do to help find solutions?" But you know, I think it was interesting because once Dr. Kunz and I started talking about it, I also mentioned to her that I have had the privilege because I work in a very small research space of cholangiocarcinoma, that I have had the privilege of participating in an all-female advisory board. And it was again, a very purposeful creation and composition of an advisory board in partnership with industry and myself. I helped chair that advisory board, and it was night and day in terms of the way that the advisory board ran, the way in which there was engagement and participation. And so, we kind of started talking about, "Well, what if we started coming up with these types of solutions, and how could we flip the script and be able to see positive impact?" Dr. Shannon Westin: I'm an advisory board participant myself, in a predominantly female-driven cancer, and a female-dominant physician, and still, we have a long way to go in GYN oncology as well. I'm often the only woman at the table, and so, I'm so grateful to your leadership for kind of calling this out. I guess before we get too much into your paper, I want to be mindful for listeners that maybe don't participate in these advisory boards, can you give us a little bit of a rundown with what happens at these tables? Dr. Pamela Kunz: Dr. Shroff, I'm happy to let you start if you want to. Dr. Rachna Shroff: Okay. So, you know, advisory boards are typically composed of anywhere from five to 15, 20, sometimes participants. And usually, the composition is what are historically called KOLs. So, people who are thought of as thought leaders in a specific space, and advisory boards are typically organized by an industry partner, and that partner decides on the question, the question that they want the advisors to address. Oftentimes, it's related to a drug that they are developing, and it could be as early as, you know, "How do we design the initial clinical trials," to "How do we bring this to a phase III, and to the FDA, and to market?" So, it can be anywhere along the continuum of drug development. And the advisors are basically often given some, maybe a little bit of pre-reading and homework, but we basically come together. Pre-COVID, we came together in person, I think since COVID, it's been a little bit of a mix in terms of virtual opportunities as well as in-person opportunities. And it's anywhere from three-hour up to full-day, if not a day and a half of discussions in a room where the company, or the sponsor is asking very specific questions in terms of helping pick our brains and ask us to help develop their drug, and trial design, and help them focus their efforts in a very specific manner. Dr. Pamela Kunz: Yeah, maybe I'll add to that. So, the KOLs that Dr. Shroff mentioned are Key Opinion Leaders, and I think what's really interesting-- and I certainly learned more about this process in the course of writing the paper, but Key Opinion Leaders are really selected on the basis of metrics that are themselves biased. So, it's number of podium talks, number of publications, number of times you've maybe chaired a prior advisory board, or participated in an advisory board, or been on a steering committee, or PI'ed a clinical trial. And I think as our audience likely knows, many of these metrics were themselves skewed and there are disparities to many of these metrics, I think, as Dr. Shroff mentioned in the beginning. And I think the other really interesting thing is that companies don't often have standardized ways to approach or track who they are inviting to their advisory boards, and the composition of advisory boards, and they are often, sometimes third parties will often organize the advisory board. So, it really has historically not been done in a very intentional or deliberate way. Dr. Shannon Westin: Those are really great points, and I think we're seeing it all the time. I also think that it's kind of like that idea, like the rich get richer, right? And so, it's on us to some degree too. As we rise and become the lead authors, and are the chairs of the steering committee, and that's what I heard you say, Dr. Shroff, is like being very mindful about who you select, or who you ask your industry partner to select. So, I think there is a role there. I completely agree with you that calling attention to this is going to make it-- because it can't just be a couple of people doing it. It needs to be a widespread movement. I guess the next question-- we've talked a little bit about how these boards are selected. How does the lack of women at the table impact the patients? How does it impact the women themselves? Like, why does this matter? Dr. Rachna Shroff: Well, I mean, I can start with the latter in the sense of how does it impact the women? And it's like you said, the rich get richer. And so, I think because these advisory boards are often the first place that trials are discussed and or developed, those advisors tend to lend themselves to having pivotal roles in the trials that are being designed. And pivotal roles include Global Steering Committee participation. And Steering Committees are formed usually at the get-go of a clinical trial, and typically authorship for the subsequent publication, and or presentations, are determined by the Steering Committee composition. And so, if you don't have a seat at the table at the advisory board, you are more than likely not going to have a seat at the table on the Steering Committee, which then leads to not necessarily being at the podium, and or the first or senior author on the subsequent publication. And so, unfortunately, it's very much a snowball effect in terms of not being able to have women participate along the continuum of the development of a drug or a therapy in a specific disease site. And then of course, those things potentially impact the advancement of the woman in terms of her career, right? Because at the end of the day, there are still very somewhat outdated, promotion and tenure, things that are looked at, including authorship, and lead and senior authorship, and platform presentations, and how many practice-changing studies you've been involved in. And so, if you don't necessarily start at that advisory board, you may have that impact affect your ability to get promoted and advance in your career as well. And then, Dr. Kunz, I'm sure you'd love to talk a little bit about the other. Dr. Pamela Kunz: I agree. I think you really painted a nice story of like this massive domino effect that not being at that first table has on a woman's scientific opportunities, and really on their career. And so, I think that it's really trying to help create opportunities for women. I will also-- we may get to talk about this a little bit later, Dr. Westin, but really women and underrepresented minorities and really looking at sort of the intersectionality of gender and other underrepresented characteristics, because I think we really also want to indicate that we need really a diversity of all types of voices on these advisory boards. Dr. Rachna Shroff: And I just will say that, you know, just like Dr. Kunz mentioned that there's something to be said because the more diversity of representation we have at the table, the diversity of thought there is in clinical trial design. And to your question, Dr. Westin, smarter, more innovative, more equitable, and more accessible clinical trials will inevitably come out of diverse voices that are helping to design that trial. Dr. Shannon Westin: Yeah, and I think that's what we want, right? There's obviously two major issues here. We want women to succeed so they can do more research and help our patients, and we want our patients to have the best possible outcomes, and get the best drugs, and have access to them across all types, you know, no matter where they are or where they're from. So, we've touched on those two critical issues. I do want to expand a little bit. Do you have information of how this lack of gender parity may intersect with traditionally disenfranchised groups? You were kind of starting to get at this, I think, Dr. Kunz. Dr. Pamela Kunz: I can certainly touch on that. I mean, I think that this concept of intersectionality was actually coined by a law professor, Kimberlé Crenshaw, and it really speaks to the fact that a number of underrepresented characteristics when experienced together, those individuals can experience an extra burden of discrimination. And I think we can see that, where whether they're women of color, or who have other underrepresented characteristics such as disability, et cetera, really don't have a voice at the table. And I think we need to be especially mindful of that. And I…

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    Universal Germline Genetic Testing in GI Malignancies Nov 01, 2022
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    Dr. Shannon Westin discusses germline genetic testing in gastrointestinal cancer with Heather Hampel and Dr. Matthew B. Yurgelun. TRANSCRIPT The guest on this podcast episode has no disclosures to declare. Shannon Westin: Hello, everyone, and welcome to another episode of JCO After Hours. This is our podcast where we get down in the nitty-gritty of articles that are published in the Journal of Clinical Oncology. I am your fearless leader and host, Shannon Westin, the Social Media Editor of the Journal of Clinical Oncology, as well as Professor of Gynecologic Oncology at The University of Texas, MD Anderson Cancer Center. And I am very excited to bring two guests in today to discuss a review article that was published in a special series on, 'Precision Medicine and Immunotherapy in GI Malignancies,' back in June of 2022, and this is, 'Point/Counterpoint: Is It Time for Universal Germline Genetic Testing for All GI Cancers?' And please note that our participants have noted no Conflict of Interest. So, without further ado, let me welcome our guests. First is Heather Hampel. She is a Cancer Genetic Counselor, and the Associate Director in the Division of Clinical Cancer Genomics, and a professor in the Department of Medical Oncology and Therapeutics Research at the City of Hope National Medical Center. Welcome, Heather. Heather Hampel: Thanks so much for having me. Shannon Westin: We're also accompanied by Dr. Matthew Yurgelun, he is a Senior Physician in Medical Oncology at the Dana-Farber Cancer Institute, the Director of the Lynch Syndrome Center, and Assistant Professor of Medicine at Harvard Medical School. Welcome. Dr. Matthew Yurgelun: Thanks for having me. Shannon Westin: And we have all decided we were going by first names. So, audience, don't be alarmed. Okay, let's get right into it. So, this is a really great review. I learned a ton and I think, you know, just to kind of get back to basics, I think we've been seeing an increase in the use of germline genetic testing across a number of different cancer types. As I mentioned, I'm a gynecologic oncologist, certainly this is something we're doing for patients with ovarian cancer. What are the reasons this has become so widespread across all cancer types? Heather Hampel: Matt and I probably agree on this one. I will, but I'll say you a couple of reasons, and see if Matt has any to add. I think that 2013 marked a major turning point in the field of cancer genetics for a couple of reasons. One was; the advent of next-generation sequencing, so that we could do multiple genes at the same time for a lower cost. The other was that that was the year the Supreme Court struck down the patent on BRCA1 and BRCA2, which allowed lots of different competitors into the market to offer sort of these pan-cancer panels, including, BRCA1 and BRCA2, among other genes. And the price has dropped precipitously since then, giving better access for patients. The competition, I think, has been good, so that a lot of the laboratories now will offer out-of-pocket maximums of $250. And then, we've seen a lot of research. Because of that, I think, where we've just done pan-cancer panels on different solid tumor cancers, just to determine what the prevalence of mutations is, all of this is sort of leading to, I think, just greater use of germline genetic testing across the board. I don't know. Matt, what do you think? Dr. Matthew Yurgelun: No, I fully agree. This is an example of the more you look, the more you find, and I think we've seen that both in the studies that have been done looking at multi-gene panel testing in virtually any setting across different cancer types and then I think people who use these in clinical practice, whether they are genetic counselors, oncologists, gastroenterologists, gynecologists, primary care physicians, I think as people have become more experienced and more comfortable using them in routine practice—I think it's not an uncommon phenomenon for those of us who use these to find things that were somewhat unexpected, which kind of naturally leads to the question, "Well, what else might I be missing if I'm not doing these tests further and wider?" What's made it a little bit difficult is that this is an example of testing that's become available commercially before we really understood how to use it. And so, we've been figuring a lot of this out kind of on the fly a little bit. Shannon Westin: Yeah. I think it brings up, and not to get too nitty-gritty right from the beginning, but to me, it brings up the whole idea around variance of uncertain significance, right? I think we've really struggled with this on the GYN space, and I don't know how common that is for you all in the colorectal space, but we get answers, we don't know how to tell a patient what to do with that information. And in fact, we've personally seen people get risk-reducing surgeries, probably not appropriately in response to these variants. Dr. Matthew Yurgelun: It's a real phenomenon, and it's the other side of the more you look, the more you find. You know, you end up finding a lot of these variants of uncertain significance. I think we've become a lot more comfortable and maybe even cavalier about them as panel testing has become so widespread. But there are data out there, and not to mention just anecdotes of people who are potentially being harmed by these variants of uncertain significance, as you said, whether it's through unnecessary surgery, whether it's even just psychological burdens and harms that come from the angst of those uncertainties. So, it is important that we be thoughtful about just how to use this technology. Heather Hampel: And really it is, "the more you look, the more you'll find." So, on a panel of about 50 genes, there's about a 30% rate of finding a variant of uncertain significance, increase that panel to 80 genes, you're up to probably a 40 to 50% chance of finding a variant of uncertain significance. A panel of 150 genes, maybe an 80% chance of finding a variant of uncertain significance, and it becomes almost the rule and not the exception. So, this is where genetic counseling becomes really important in terms of having people understand that these are sort of common, and usually, not anything, and setting expectations so that people don't over screen, or overreact, or get in a situation where they're mismanaged. And this is one of the things that Matt and I go back and forth a lot about when you start to think about testing all-comers because if you're testing all-comers, you kind of have to give up pre-test genetic counseling and kind of move to a post-test genetic counseling scenario more for the positives, or people with a strong family history or concerns. And I know Matt worries, and I do too, that that's where we've risked these variants of uncertain significance getting mismanaged, particularly in centers that aren't as used to dealing with cancer genetics. Dr. Matthew Yurgelun: I would just add one more concept on that. We're probably also, in the case of some of these larger panels, dealing even with genes of uncertain significance. At the end of the day, it's the commercial laboratories in many cases that are really setting the agenda on some of these panels as far as choosing which genes to include or not to include, and a lot of these genes are genes where the link to cancer risk is sometimes very preliminary. Shannon Westin: Those are some great points. I think just to kind of take a step back, since the paper's in GI cancers, and I want to make sure we have—we have a mixed audience out there, so I want to make sure we level set. So, can you tell us the current standard of practice for germline testing in GI cancers? What are you looking for specifically? What are some of the things that you know are of certain significance? Heather Hampel: Currently, the NCCN guidelines recommend that all pancreatic cancer patients be offered germline genetic testing. And what is very new in 2022 is that there's now a consideration recommendation that you could consider offering germline genetic testing to all colorectal cancer patients. That is logistically much more challenging than offering germline genetic testing to pancreatic cancer patients because there are so many more of them. And it comes with a page of caveats of things that you need to think about before you would consider offering testing to all colorectal cancer patients. And then, I'd say among the rest of the GI cancers, you're going to be offering testing in cases of early onset, multiple primaries, maybe three affected's on the same side of the family with cancers that could go together in a family, and raise a red flag that there could be hereditary, diffuse gastric cancer comes to mind when you think of the stomach, certainly, polyposis is an indication for testing as well. But for most of the GI organs, you're going to need early age, multiple primaries or some family history. The one clear exception being pancreas, and now, a lot of debate about colorectal. Dr. Matthew Yurgelun: And I would just add to that from some of Heather's own seminal work. Tumor testing is often used to drive a lot of this in day-to-day practice. Certainly, the presence of microsatellite instability, and/or mismatch repair deficiency. This isn't limited to GI cancers, obviously, but it is where we often think about it the most. But any finding of mismatch repair deficiency in microsatellite instability should really strongly trigger strong consideration for germline testing, at least for Lynch syndrome, which is often, at least a way in the door for germline testing a bit further and wider. Shannon Westin: Yeah, that's kind of what we've done in endometrial cancer, and it's definitely a less expensive way of kind of getting at that, and we use those same Amsterdam criteria for the full germline outside of that. But that's really how we've gotten to universal testing for endometrial is using the less expensive protein testing, you know, as a trigger to break down the door. Heather Hampel: But it's not necessarily less expensive anymore. So, that's where things are getting a little challenging. You know, at most hospitals, if you're going to do four immunohistochemistry stains, you're going to take whatever they charge for IHC times four, then you're going to have a reading fee for the pathologist times four, and believe it or not, that adds up pretty quickly, and can become a test that's $1,500+, compared to potentially a $250 germline panel. I find it an odd situation for me to be in, who I've spent 20 years of my career advocating for universal tumor screening for Lynch syndrome. But I do feel that we really need to relook at the cost-effectiveness analysis now that the cost of germline genetic testing has gotten so low, and we need to think about what we're missing with universal tumor screening. So, yes, it will detect most of the cases of Lynch syndrome, and it should detect anyone who could benefit from immune checkpoint blockade therapy. And those are very important points, and I think that's the reason we're never going to go away from tumor screening. But it's not going to detect mutations in any other cancer susceptibility gene. And that's what you risk missing if that's your only approach. Shannon Westin: Those are some great points. Again, bringing those of us that aren't GI experts, up to speed, what's the overall incidence of these germline genetic abnormalities in GI cancers? What are we looking for? Dr. Matthew Yurgelun: I think it depends on which cancer you look at, and it also depends a little bit on even just how you define the prevalence here. Where it's been a little bit difficult, or where it's been kind of moving goal posts is that the panels that we're using in day-to-day practice are getting bigger and bigger, and certainly, the panels that are being used in a lot of the studies that are examining this are getting larger and larger. And as far as the number of genes being tested-- and not surprisingly, as you test more genes, you find more stuff. We make a point in the paper that some of the older studies, these are all still relatively new studies, but some of the older studies that have looked at gene panels of say, 30 genes or fewer, you actually find germline prevalence rates that are maybe 10% or lower across most of the GI tract malignancies. But as you start getting into panels that are 50 genes, 60 genes, 100+ genes, that's when you start getting these prevalence rates that are 15%, 20%, almost across the board. But the prevalence is only part of the story, in my opinion, it's a matter of what you're finding, in addition to how many people you're finding stuff in. Because you know, finding a diagnosis of Lynch syndrome, finding a BRCA1 or BRCA2 abnormality, things that are high penetrance, clearly actionable that we understand reasonably well, I would argue is much more impactful than finding something like a monoallelic MUTYH pathogenic germline variant, which arguably has very little clinical significance for the person themselves, and is honestly, much more common than some of these other things too, and drives up some of these prevalence rates. Heather Hampel: I agree, Matt, completely. And I struggle myself, sometimes, with how people should report out the incidence of mutations in series like this because when you include those MUTYH heterozygotes, you include your APCI 1307Ks, you're padding the numbers, but are you finding something that's going to really make a major management change for that family? I don't know. The one thing though that has stuck with me as I look at this is that it appears that people who meet the criteria for testing aren't much more likely to test positive than people who don't meet criteria for testing. And as a genetic counselor who, you know, loves to take family histories, and for years, liked to believe that if I took a good family history, and assessed it, I could pick who was going to test positive appropriately, it's been a little bit of a dash to the confidence to see rates of positivity that are pretty similar in the patients who don't meet criteria. And I think that's been a challenge for all of us. So, if we could pick these cases well, it would be one thing, but I don't think we can all the time, outside of Lynch syndrome. Lynch syndrome, I think we can pick, to a large degree, through tumor testing more than family history. But the non-lynch genes are much harder to predict based on age of diagnosis, family history, or any other clinical criteria. Dr. Matthew Yurgelun: I totally agree, and for me, that's what moved the needle a handful of years ago with pancreatic cancer in particular, in my own mind, is that it was becoming quite clear that you could find some of these with clinical criteria or even just clinical intuition, but there were a lot that were just being missed. We were looking at age of diagnosis, we were looking at family histories of BRCA-related cancers, and family structures being what they are, in many cases, you know, the fact that pancreatic cancer, even in the setting of some of these germline variants is often diagnosed well after age 50, and often after age 60, or even after age 70, you know, our usual clinical criteria just weren't working. Shannon Westin: I think you kind of already started touching on this, but I'd love to get a little bit more, you know, what would be the additional benefits to doing this universal testing? I think one of…

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    Light From Darkness - Navigating Postmortem Tissue Donation Sep 20, 2022
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    On this episode, our guests discuss how postmortem tissue donation can provide meaning to patients and their loved ones. TRANSCRIPT Dr. Shannon Westin: Hello, everyone, and welcome to another episode of JCO After Hours. This is when we get in-depth on articles that are published in the Journal of Clinical Oncology. I am your host, Shannon Westin, GYN Oncologist and Social Media Editor of the JCO. Excited to be here today to discuss a really awesome paper. It was a Comments and Controversies named "Postmortem Tissue Donation: Giving Families the Ability to Choose," just published on August 26th, 2022. And I'm joined by a number of the authors. It's going to be a really incredible discussion. I'd like to introduce each of them, and then we'll get right down to it. First is Allen Gustafson. He is the founder of the Swifty Foundation, which he started with his son, Michael, who sadly died in 2013 of medulloblastoma. And this foundation really was the catalyst of the group Gift from a Child, which we're going to really discuss today. In addition, I'm accompanied by Dr. Angela Waanders, the Interim Head of Neuro-Oncology and the Director of Precision Medicine and Associate Professor at the Ann & Robert H. Lurie Children's Hospital of Chicago; Beth Frenkel, a Tissue Navigator at the Children's Hospital of Philadelphia; and Dr. Mateusz Koptyra, a Senior Scientist and the Director of the Center for Data-Driven Discovery in Biomedicine at the Children's Hospital of Philadelphia. So, thank you all for being here. I'm so excited to discuss this paper. I think this is something that our listeners are going to be really interested in and really want to move forward. So, welcome. Allen Gustafson: Thank you. Dr. Mateusz Koptyra: Good morning. Dr. Shannon Westin: So, let's get started. You know, postmortem tissue donation is so critical for research and improving outcomes for our survivors. I think the best way to start, I'd be very interested to hear how each of you got involved with this. And Allen, let's start with you because I think that your story is so important. Allen Gustafson: Sure. Thanks, Shannon. Well, as you mentioned, our son, Michael, died of medulloblastoma in 2013 at the age of 15, and probably about four months before he died, he knew his life was going to end. And he got the idea of donating his body to science, so they could use him to find the cure. And he used to refer to that as his master plan. So, obviously, that charge was put on his mom and I to figure out how he could do that. And although we were being treated by two excellent hospitals, one here in Chicago and one in Boston, they were not helpful in terms of helping us with his final wish. And so, it was really through Nancy Goodman from Kids vs Cancer and his pediatrician going above and beyond the call of duty that Michael was finally able to donate his spine and his brain, some of which was sent to Texas Children's and some of it was sent to SickKids. And it became both very meaningful for him as his life ended, and it was also very meaningful for us in terms of the important step we took as a family in our grieving and our loss of him. And as you mentioned, our work with the Swifty Foundation, really, his choice there was prescient, in that we didn't realize how important postmortem collection is for advancing scientific discovery, nor did we realize how important this could be for other families. So, it all started with his experience in terms of our journey with Gift from a Child. Dr. Shannon Westin: That's so incredible. I'm so glad that you chose to do this work. Dr. Waanders, do you want to pipe in? Dr. Angela Waanders: Yes. So, I think reflecting back, it really was a serendipitous moment in meeting with Patti and Al. I can still remember it was in 2016, I believe, at a Children's Brain Tumor Network annual meeting. I'm a Physician Scientist, a practicing Neuro-Oncologist, and at the time, I was in the laboratory trying to dissect out, why do children die from brain tumors. I was also taking care of children who were losing their battle. And so, a couple of years prior, I had been trying to figure out how to set up a postmortem or a research-based autopsy program. I knew from talking to some of my own families and helping to make it happen, it was really important and meaningful to them. But the logistics were beyond me as a single provider. You know, it really takes a lot of logistics going from the initial conversation, to how to make it happen. And so, one of my colleagues, Dr. Rishi Lulla, introduced me to Patti and Al. We realized we had a shared mission. And so, I've been very fortunate and grateful to be involved in this project. And, you know, including some of the comments from the paper, as well as meeting and talking with families, and seeing even the larger scope, families do want us to ask. This is meaningful for many families. And it's a really special moment for me as a provider in any of the autopsies that I help to coordinate with our Tissue Navigator, Melissa Williams, at our hospital, we do try to have a follow-up conversation with families when they are ready, and those conversations are just so meaningful. I have several stories of things that I hadn't even imagined would be meaningful to families. And so, to me, this has really been something that wearing both hats as both a physician, and a scientist, that is one of my projects, and things that I've been involved with that I think will have the biggest impact when I look back at the end of my career. Dr. Shannon Westin: I completely agree with you. Dr. Koptyra, I'd be interested to hear your perspective of how you got involved with this. Dr. Mateusz Koptyra: Hello. So, working as a scientist at Children's Hospital of Philadelphia, I actually had the privilege of also working with Dr. Angela Waanders here at CHOP. And part of my scientific effort was really focused on utilizing biospecimens into research. And specifically in the lab, we are generating two more models which can be used in wet bench research that specifically relates to cell lines or xenograft models used in science to explore tumor biology, novel therapeutics, et cetera. And at that point, Angela actually introduced me to the Gift from a Child program. And initially, I offered my assistance, but quickly realized how working with the Gift from a Child program and with Swifty Foundation, adds additional meaning to our daily work in the laboratory. So, from initial assistance, I quickly became fully engaged in the process of tissue banking, processing, and model generation out of specimens we received on their website. Until today, I'm leading that effort on the laboratory side here at CHOP. Dr. Shannon Westin: Thank you. And then Beth, I think we'd be interested to hear your perspective as well. Beth Frenkel: So, thank you very much for having me. I started my career as a funeral director. I did that for about 10 years or so before moving into organ and tissue transplant. My job, specifically, was advocating with our community and our healthcare partners to make sure that every family was given the opportunity to donate, to help others. What really got me into my job here with Gift from a Child is that my mom was diagnosed with an inoperable brain tumor, and there were no treatment options for her at all. And so, after her death, it really led me to start researching brain tumors and to see the lack of treatments, not only for some adults, but for all of these kids. So, that's what really made me seek out this opportunity with Gift from a Child, and to work with all of these wonderful people to try to help these kids find better treatments and cures. Dr. Shannon Westin: You all have such incredible stories, and it's so inspiring to see people take terrible things that have happened to you and make it into something so much more positive. So, I'm so inspired by all of you. I know personally as a surgeon and a physician, I sometimes feel really uncomfortable approaching the idea of postmortem tissue collection with patients. So, I think one important aspect of it is—you know, of course, we've talked a little bit about the positive impact on research, but can you all speak a little bit more about how family members actually may benefit from this practice in being offered this opportunity? Allen Gustafson: I'd be happy to start. I think I can speak both from a personal experience, as well as from the many families we've spoken to and surveyed. I think the number one reason families want to make this choice is to help other families. I mean, it's the one bit of light that can come from perhaps the darkest time a family is ever going to go through. I know that's what prompted our son, Michael, in his words, to help as many as he can. And as we talk to other families, that is their principal reason for giving, as well as certainly to create a legacy for their child. As I mentioned, our son was older, so it also gave him some personal meaning at the end of his life. And helpful in the grieving process, both to know that your loss may be benefiting another, but also the researchers that have received Michael's tissue have been keeping up with us in terms of publications that his tissue has helped fuel. And there was even a protocol change in how recurrent medullo is dealt with that Michael's tissue was a part of. So, again, to know that is so gratifying for the family. Dr. Shannon Westin: I think that just knowing that and hearing that from personal experience should, hopefully, help our practitioners that are listening feel more comfortable with approaching it. The consensus conference that you all discussed in the paper, how did this come to be? What drove that discussion and where people ended up? Angela, if you want to tackle that? Dr. Angela Waanders: I can take this question. So, the consensus meeting in 2018 happened in Philadelphia when I was still at Children's Hospital of Philadelphia. It came out of a conversation with Patti and Al. We really wanted to dive down deep into understanding what barriers existed. I knew from the clinician side, it's uncomfortable. It is a really difficult question to broach, and so, we thought that from hearing from families-- and we specifically chose a mix of families that were able to donate and those who were not able, or who hadn't been asked, and it's a meeting that will forever stick in my head, just the moments and things that I would not have imagined. And I think for all of us who were involved, the families that did not have the option to donate, or who weren't asked, I think the quotes and the comments from those families were the most memorable. To kind of step back a little bit in how I became involved in this too, it's trying to make sense of the nonsensical. I mean, children should not die from brain cancer, and children should not die from brain and spinal cord tumors. We are uncovering the biology, the past decade has been really exciting from a biology standpoint, but having matched specimens from the time of diagnosis to time of death, will really answer crucial questions, which are, why do children die? And so, as clinicians, we just kind of need to get out of our own way, get out of the discomfort of asking, and, I think this is something that our generation of physicians are modeling. Another big aspect of this too, and I think this came out of the consensus meeting in 2018 and is important to continue to illustrate and emphasize; tissue that's taken, you know, this precious tissue, this precious gift, the mandate is to share it broadly. So, we did develop standard operating procedures so that we can try and make cell lines, we can have matched tissue for DNA and RNA extraction, protein extraction, we can look at areas of tumor, areas that don't look like tumor. And with the understanding, this tissue will be shared as broadly to every laboratory who is studying brain cancer or something relevant, and that the findings from this precious tissue will also be redeposited or shared again. So, this really is a legacy of life and celebrating the life of these children who've lost their battle. Allen Gustafson: If I can add one thing on the consensus meeting that the other great thing that came from that, we wanted to query families about how clinicians should talk to them, or what's the best way to talk about this very sensitive subject? And we were right at the beginning of our Gift from a Child, creating the program. And so, our website and our materials have all been influenced by the input of these families. And so, we created these to help clinicians with this very difficult conversation. And that consensus meeting really helped us understand as best we can understand any individual family, how to communicate this very, very sensitive subject at such a very difficult time in their family's journey. Dr. Mateusz Koptyra: If I can add something as well, I actually had this privilege during, and after that conference to provide a tour for some of these families around the laboratory, and kind of refers to us into your former question a bit, but I was able to show the biorepository where the tissue is stored as well as laboratory and some cell lines and models, which we created in the laboratory. And one thing which was really striking and filling, and in words which were shared by those families, the fact that some of donated tissue, some of these families actually already donated tissue, that some of those tissues are within this biorepository, that some of the cell lines we have might be specifically from the tissue from their children, brought this almost like continuity of their life and the second meaning to family's life, just by possibility of being together in this laboratory and seeing that those models work. Talking about investigators who actually share those specimens had exactly the same effect, bringing this kind of closure to the fact that this tissue still brings meaning on a daily basis. Dr. Shannon Westin: It's wonderful. You know, Allen, I wanted to kind of expand a little bit on something that you started talking about around "best practices for requesting" because I really do think that's a huge-- one of the huge barriers is that we feel uncomfortable as clinicians in asking. And so, I'd be interested to hear a little bit more about what are the best ways to approach this, and to give these families this opportunity. Allen Gustafson: Well, I can certainly give the parent point of view on this. First, I would say that our Oncologist and the healthcare team helped us make difficult decisions throughout Michael's cancer treatment and had a lot of very difficult conversations with us. And so as a family, we would see this perhaps as another difficult conversation to have in the journey of our son's cancer. And again, I would encourage physicians to think about it like that, because they are quite practiced in having difficult conversations with family members. I think the best time that obviously, this conversation would be received by a family is when it becomes clear that our child is not going to survive their cancer, or perhaps when they enter into hospice. Again, it's such a difficult time for us. And it may be the case that we don't respond particularly well to what the clinician has to offer. And I know, you know, throughout Michael's cancer journey, I wasn't always at my finest hour with my Oncologist in terms of my response to what he had to tell me. So, that certainly may be true here as well, but again, I think the more important thing here is that it's really the family's choice to decid…

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    Physical Activity Improves Survival in Colorectal Cancer Sep 12, 2022
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    Dr. Westin and Dr. Justin C. Brown discuss how physical activity can improve disease-free and overall survival in colorectal cancer and its potential application across all cancer types. TRANSCRIPT The guest on this podcast episode has no disclosures to declare. Dr. Westin: Hello, everybody, and welcome to another episode of JCO After Hours, the podcast where we get in depth on recent manuscripts published in the Journal of Clinical Oncology. And it is my great pleasure today to tell you we're going to be talking about a really important manuscript: "Physical Activity in Stage III Colon Cancer: CALGB/SWOG 80702 Alliance Study." And this was published in the JCO on August 9th, 2022. All participants in the podcast have no conflicts of interest. And I am very excited to welcome the first author on this important paper, Dr. Justin C. Brown. He is the Director of the Cancer Metabolism Program and Assistant Professor in Cancer Energetics at the Pennington Biomedical Research Center at Louisiana State University. Welcome, Dr. Brown. Thank you for being here. Dr. Justin C. Brown: Thanks so much for having me. Dr. Westin: So, this is some really important work, and I think we're starting to see more and more really objective data around the importance of physical activities. But before we get too far down the road, I do want to level set because this was a study in colon cancer. So, just because we have a really mixed audience, give us a quick bit of information about the standard treatment for colon cancer and where we are with survival outcomes. Dr. Justin C. Brown: Yeah. So, for most patients with early colon cancer, they'll get upfront surgery. And then a subset of patients who have high-risk features for recurrence, or have positive lymph nodes or tumor deposits, will get three or six months of chemotherapy. And outcomes have improved over time for this population, but there is still a lot of heterogeneity, in that, some patients do better than others. And you know, a lot of patients ask as they finish therapy or as they're starting therapy, "Are there things I can do that potentially could improve my outcomes?" And so, we think that this data will provide physicians with a lot of really important information regarding the benefits of physical activity during chemotherapy, as well as after therapy, for patients with stage three colon cancer. Dr. Westin: Okay, that's great. And so, again, continuing on that level-setting piece, before this study, what did we know about the impact of physical activity on outcomes in colon cancer? Dr. Justin C. Brown: So, we knew that there was some association between physical activity during chemotherapy and after chemotherapy with disease-free survival and overall survival. There have been studies that have linked those two things. There was some uncertainty about, what is the best exercise or physical activity prescription? And so, a lot of the current recommendations before this study basically said encourage patients to avoid sedentary behavior, encourage them to be as active as they can be, because some activity provides benefits over no activity. But for the patient who really wanted the specifics of how much should I be doing, when should I be doing it, what types of activities should I be doing, should I avoid certain things, the evidence was really absent. And so, what this study provides is a lot of important clarity for both physicians and patients about the types of activities that can maximize their disease-free survival and overall survival. Dr. Westin: I think that's so important because you're exactly right. We all have those patients that you give them a vague, and they're like, "No, I need instructions. I need to know how much time. I need to know what I'm doing." And it can be really frustrating because—I know personally, I'm like, "Well, this is what I do." And I'm like, is that enough? I have no idea. So, this is really important work. And before we get into the specifics of the work, can you just give our listeners a little information? Do we know anything else about physical activity in other cancer types? Like, beyond colon cancer, is this something that's broad-based across everybody? Dr. Justin C. Brown: Yeah. So, there is emerging observational evidence that physical activity after diagnosis of early breast cancer, of early prostate cancer, is associated with improved disease outcomes, so disease-free survival, overall survival; that's observational data. We do have randomized clinical trial data on other quality of life endpoints and biologic endpoints in a variety of tumor types. And we know that patients who engage in physical activity or exercise during and after treatment tend to have better quality of life, they have less fatigue, they have improved physical functioning, they have reduced inflammation, improved insulin sensitivity. So, there's a variety of short, medium and potential long-term benefits to being physically active after your diagnosis of cancer. Dr. Westin: Perfect. And how did you end up here? What made you interested in this work? Dr. Justin C. Brown: So, my story dates back all the way to 2002. So, my father died from metastatic colorectal cancer. Dr. Westin: I'm sorry. Dr. Justin C. Brown: No, no, it's okay. I mean, if that didn't happen, I wouldn't be here today. And so, he is with me every day. And, when he asked his physician, "Is there anything I can do to improve my long-term outcome?" This was 2002 before we knew how patient lifestyle factors really improved or impacted disease outcomes. And so, my whole life's mission has been focused on trying to empower cancer survivors, so people from the point of diagnosis on, with information about how the choices they make outside of the oncology clinic have a profound impact on how they feel, function, and survive. And so this has come full circle for me because now I'm able to generate evidence that hopefully will inform clinical practice about how patients who are exactly like my dad and wanted to know what they could do to improve their outcomes, we now have the data that we can provide more precise recommendations about what patients might consider doing to improve their long-term disease outcomes. Dr. Westin: Great. Wow. It's so inspiring, and again, I am sorry for your loss. But I'm glad that you're really transitioning it into positive things. So, let's help everybody understand first just the overall design of the trial that you utilized, the CALGB/SWOG 80702 clinical trial. Dr. Justin C. Brown: Yeah. So this trial was a two-by-two factorial trial, and it randomized patients to three years of Celecoxib; the anti-inflammatory drug, or three years of placebo. And that was the primary analysis. The primary hypothesis was that Celecoxib would improve disease-free survival versus placebo. And that paper was published by my mentor, Jeff Meyerhardt, in JAMA last year. And that analysis showed that Celecoxib did not improve disease-free survival over placebo. The other factor of the two-by-two design was a randomization to three months of FOLFOX therapy, 5- fluorouracil and oxaliplatin, or three months of FOLFOX. And that analysis contributed to an international pooled consortium called the IDEA Consortium. And that analysis was published in 2018 in New England Journal of Medicine, and the follow-up overall survival analysis was published in Lancet Oncology in 2020. And that showed that while overall, three months of FOLFOX was not inferior to six months, there were some lower-risk patients that achieved good disease control with a shorter regimen of chemotherapy. And so, that has changed practice, and now there are certain lower-risk patients that are getting treated with three months of FOLFOX chemotherapy instead of six months. But patients with high-risk features still continue to get six months of therapy. That was the primary questions that that study was designed to answer: the Celecoxib versus placebo and then the contribution to the international pooling project to answer the question of three versus six months of postoperative therapy. Dr. Westin: Well, that's a really clever design. And then I love how you have an additional question built in here. So, why don't you explain how you incorporated your exercise objectives and also what this nested cohort design is? Dr. Justin C. Brown: Yeah. So, this is a unique opportunity to leverage an ongoing clinical trial to conduct an observational study. So, what we did is, about midway through chemotherapy, we asked patients if they wanted to participate in a lifestyle substudy. And if they chose to participate in the lifestyle substudy, they were asked questions about their physical activity and their dietary patterns and how much they weighed. And we measured those things midway through chemotherapy, and then we also measured them again about six months after patients finished their chemotherapy. And so, what this allowed us to do is to leverage all of the amazing resources that were put into place in the randomized clinical trial—that is, a homogenous patient sample, uniform treatments—and systematically ascertain disease outcomes to answer a question in an observational setting—that is, "Does physical activity relate to disease-free survival and overall survival?" So that is the nested cohort within the larger randomized clinical trial. Dr. Westin: Okay, perfect. And then just tell us how you measured the physical activity and the questionnaire that you utilized. Dr. Justin C. Brown: Yeah. So physical activity was measured by a self-reported questionnaire, and the questionnaire is included as a supplement to the JCO paper. So, if people are interested in using this questionnaire, it is available. And it asks 10 different types of physical activities, and it asks the frequency with which those activities are done in the past two months. And using the answers that the patients provided, we were able to calculate which patients were more physically active versus those that were less physically active. And we were also able to understand were the activities that they participated in more vigorous or less vigorous. So, it provided us with a lot of important details regarding the types of physical activities that patients reported during and after chemotherapy. Dr. Westin: Great. That's so interesting. And then, of course, we know diet is important, right? So, you did assess diet as well in this group. You want to give us a little bit of detail on that? Dr. Justin C. Brown: Yeah. So, we measured diet with what's called a Food Frequency Questionnaire, and it asks a series of questions regarding habitual dietary intake. And we know that people who are more physically active tend to be more mindful about what they eat. And so, that's an important confounding variable in trying to understand the relationship between physical activity and disease-free survival. So, we measured diet using that questionnaire. At the same time, we measured physical activity during and after chemotherapy. And that was included in our analysis so that we can attribute the association that we observed to the physical activity per se. Dr. Westin: Okay. And how often did you assess these time points? I'm sorry if I missed it. Dr. Justin C. Brown: So, we measured physical activity and diet two times. We measured it midway through chemotherapy, and then about six months after patients finished their chemotherapy. Because we know that activity, as well as diet, changes from when patients are being actively treated to after they finish their systemic therapy. Dr. Westin: Okay. Perfect. Great. All right, so let's hear it. What were your primary findings? Dr. Justin C. Brown: So, the benefit for the simple messaging is that any activity is better than no activity. That is, if patients need to know the bottom line, my advice is that they find an activity that they like to do and they do it for the rest of their life. For patients who want a little bit more precision, we can think about physical activity on a spectrum of intensity. So the examples I would give a patient is we can do walking, we can do jogging, and we can do running. And jogging is more intense than walking, and running is more intense than jogging. And so, if you decide to do more intense activities, you don't have to do them as much in a week. If you choose to do walking, you need to do more walking than if you choose to do running. And so, this will help to clarify what types of activities are beneficial. So, some people might choose to play tennis, which is a vigorous activity, one day a week. And that would provide them—from our analysis, that provides them with a disease-free survival and overall survival benefit. If a patient says, "My joints are too old and too achy that I can't play tennis, but I can walk around my neighborhood," then we know that those patients may need to do a little bit more activity, maybe a 20 to 30 minutes a day, three to five days a week, in order to achieve a meaningful disease-free survival benefit. So, this helps us to understand with a little bit more precision what we should be advising patients. And if patients say, "I can't do this" or "I prefer to do that," that helps us to have evidence-based recommendations about what is likely to be beneficial and worthwhile to improve their long-term disease outcomes. Dr. Westin: It's so awesome. And I think it's so great to have just very clear guidelines that we can give our patients. I know I've said it already during this podcast, but every time I—because I think we all get so frustrated with these vague recommendations, like, "Okay, drink water, eat healthy." You know, really, I want bullet points of what I can do. Now, we talked a little bit about some of the findings in other cancer types that were already existing. So, can we extrapolate your findings to other cancer types? Dr. Justin C. Brown: I think there is a reasonable expectation that our findings can probably generalize to early-stage breast cancer and maybe to prostate cancer. And the reason I say this is because these are tumor sites where there is existing evidence that being more physically active is associated with improved long-term disease outcomes. Now, the specific magnitude of benefit, I'm not sure if that will generalize. But I do think that this study provides a framework to start thinking about how we can understand the specific characteristics of physical activity that might be more or less important in terms of maximizing long-term disease outcomes. Dr. Westin: That is perfect. So, tell me, what are your next steps with this work? Dr. Justin C. Brown: So, one of the findings that this study reported was that patients who were more physically active during their chemotherapy were more likely to receive more of their planned chemotherapy. They had a higher chemotherapy RDI. So, some of us on this paper have been very fortunate that we received funding from the National Cancer Institute to launch a Bayesian Adaptive Trial of exercise, aerobic exercise, during chemotherapy, and the primary study endpoint is chemotherapy relative dose intensity. So, what we're going to be able to do is to understand, in a randomized clinical trial setting, does different doses of aerobic exercise have a causal effect on improving chemotherapy RDI? Because one of the hypothesized mechanisms through which we think physical activity may improve disease-free survival and overall survival is it enhances a patient's ability to tolerate systemic therapy. And so, we have the funding. We are in the process of planning that study. It should begin later this year, and…

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    Food Insecurity Interventions for Cancer Survivors With Dr. Francesca Gany and Dr. Theresa Hastert Aug 29, 2022
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    Shannon Westin, Francesca Gany, and Theresa Hastert discuss the topic of food insecurity among patients with cancer. TRANSCRIPT Dr. Shannon Westin: The guest on this podcast episode has no disclosures to declare. Hello friends and welcome to another episode of JCO After Hours, your podcast to get more in-depth on some of the amazing work that has been published in the Journal of Clinical Oncology. I am thrilled to be here today with two fantastic investigators and researchers who are going to discuss a paper that is titled "Food to Overcome Outcomes Disparities – A Randomized Control Trial of Food Insecurity Interventions to Improve Cancer Outcomes." This was published online in the JCO on June 16, 2022. We're joined by the principal investigator Dr. Francesca Gany, who is the Chief of Immigrant Health and Cancer Disparities service at the Memorial Sloan Kettering Cancer Center in New York City. In addition to Dr. Gany, we're also joined by Dr. Theresa Hastert, who's an associate professor in Population Science in the School of Medicine at Wayne State University in Detroit. And she published an editorial that went along with this article named "The Potential of Cancer Care Settings to Address Food Insecurity." This was published in the JCO on July 1st, 2022. Welcome, ladies. So excited to hear about this work. Dr. Francesca Gany: Thank you! It's great to be here. Dr. Theresa Hastert: Thanks so much for having me. Dr. Shannon Westin: So, what we're seeing more and more of is oncologists getting into other areas of expertise. For a long time, we've all been involved with treatment trials, and we've started getting into survivorship and health services. But I think that we really are realizing there are other issues for our patients that affect their cancer care and outcomes. So, first, I just wanted to level set and see if maybe Dr. Gany, you can kick us off, can you define food insecurity and just kind of briefly discuss the prevalence patterns in women and men that are diagnosed with cancer? Dr. Francesca Gany: Sure! So, food insecurity is essentially not enough access to food to help you maintain your health. And that could come from a variety of reasons, including not having enough money to buy food, living in a food desert, where there's not availability of food and other factors that could make food inaccessible to you. This potentially has a tremendous impact on health. We see that with folks with cancer and folks who don't have cancer. We know with cancer patients, it's a particularly difficult issue because of the increased nutritional demands that come with a cancer diagnosis, the need for special diets, and decreased absorption of nutrients for certain folks. So, it's especially important that our cancer patients have access to enough healthy food, so they can have the best cancer treatment outcomes possible. Dr. Theresa Hastert: I can add a little bit about the prevalence of food insecurity more broadly. So, in the US population, about 4% of Americans have what's called very low food security. So, that's where people actually reduce the amount of food they eat because they have a lack of money for food. And by contrast, in previous work among cancer survivors, that number is closer to about 15% in sort of population-based studies and much higher in certain select patient populations. So, if you're in an under-resourced population, and as some of Dr. Gany's previous work has cited figures of more like 55 to 70% of cancer patients and survivors with low resources can be food insecure and not have enough money for food. Dr. Francesca Gany: All of this has, of course, worsened with a COVID pandemic because just food insecurity rates have gone up overall and we have certainly seen an impact on our patients in the cancer centers in which we work. Dr. Shannon Westin: And you can imagine with the high costs of drug pricing and all of the other issues around coverage of cancer care that people are having to make those types of decisions between food and shelter and basics and getting their treatment for their cancer, their treatment for their other related comorbidities. Am I on the right track? Dr. Francesca Gany: Absolutely! In fact, we did a study that specifically asked patients whether they were not purchasing medications in order to be able to feed their families. And a very high percentage of them, up to a third of patients, said that they were foregoing some of their cancer meds in order to be able to feed their family. We asked it the opposite way as well, whether purchasing their cancer meds meant that they were unable to feed their families and unfortunately, it was a similar percentage for those food insecure patients. So, it has a tremendous impact on fully engaging in cancer treatment, and also being able to take care of one's family which of course is so important to our patients. Dr. Theresa Hastert: So, in Detroit, we're in Michigan, which expanded Medicaid. So, in the work that we do predominantly among African-American cancer survivors, we find that most Americans are able to access care, like with the expansion of Medicaid, people are able to get treated for cancer. Paying for drugs is another thing but we still have a lot of food insecurity among this population. About 15% of our cancer survivors, African-American cancer survivors in Detroit are food insecure. So, it's not an insurance issue in the sense. They have Medicaid coverage and they're able to get cancer care, it might not cover every out-of-pocket expense, they still have food insecurity. So, broadening insurance is not necessarily enough to help people avoid some of these follow-on impacts. Dr. Francesca Gany: Yes! One very important issue is that looking at food insecurity at a moment in time with our patients is not enough because we know that as treatment progresses, financial hardship also progresses – financial toxicity of the cancer treatment. So, it's really important not to do just an initial screen for food insecurity and for other social determinants of health because food insecurity is certainly a window into other essential needs that have to be met, but it's really important that we don't just ask once, but that we ask in an ongoing way because we know that as time goes on, it only gets worse. Dr. Theresa Hastert: That's so important. I've talked to several providers who have these issues with patients, where it's the people who are sort of more middle class who are going into cancer and be like, 'I'm fine, I'm fine, I'm fine" when first asked if they need assistance. And it's not for several weeks or months when they start racking up out-of-pocket costs, and then suddenly, they realize they're not fine. It can become very delicate also because people are used to being self-sustaining, and financially independent, and they're used to being able to maybe help other people who have financial needs to donate to charities and things like that. And there can be a shift for people when they realize, ''Oh, no, now I need assistance.' That can be difficult for people to grapple with. And it's so important to keep checking in with patients throughout their treatment experience to see how they're doing. Dr. Shannon Westin: I think this is really a great segue into kind of getting into the nitty-gritty of the publication. I would love for you, Dr. Gany, to give our listeners a little bit of information around the trial, the patient population that you chose, and the intervention arms. Dr. Francesca Gany: Sure, I'm happy to do that! So, we started when we first saw the high prevalence of food insecurity among the patients, we were working with that are partnering with safety net institutions, we knew that we needed to do something. And so, we did a study and we looked at emergency food resources in the top 50 zip codes that our patients lived in and then we did site visits, etc, to these emergency food resources and saw how inadequate they were for our cancer patients. They were inadequate because they didn't have medically tailored foods. Often, they didn't have culturally tailored food choices. Their hours of operation were very short and with all of the appointments that our patients had to keep, it made it really hard for them to reach the pantries. They weren't that geographically accessible so that was a deterrent to patients. So, we realized that we have to do something that was much more convenient for our patients that would address their medically tailored food needs. And also, the difficulties they might have traveling to another site to get food. So, we started a medically tailored food pantry of one initially, in which we partnered with a local food bank for New York pantry site that was close by to the hospital and worked with them around food choices for our patients, etc. And would work with them to pack the bags at their site and then we would bring the bags over to the hospital. We found with our patients that there was tremendous uptake of this service, and tremendous appreciation and they reported improved quality of life and improved ability to get on with their cancer care. This grew to now 15 pantries in both safety net facilities and also Comprehensive Cancer Centers because there are a sizable number of people in Comprehensive Cancer Centers, as you know we've been discussing that are also food insecure. So, we had 15 pantries, but pantries - they're a great piece of the solution - but we didn't feel that they were enough of the solution because even though they were medically tailored and patients had some choice, they didn't have total choice in what they were getting. And especially with cancer care, people's food preferences shift, etc. And what they need to be healthy shifts. So, we explored two other options of home grocery delivery service where they would get to pick what groceries came to their home, and having the groceries come to their home eliminated the issues that come up certainly with having to carry heavy bags, etc. It was some choice that this gave them but the windows of delivery were a little bit of a problem for the patients because sometimes the food delivery services would be coming at a time that didn't work for the patients. And then, the third option was a voucher system, where people get basically a debit card, and they can buy whatever they want within, no alcoholic beverages, etc, but whenever they want to purchase with that voucher card. And we accompanied that with education around healthful food choices, nutrition during cancer, etc, which was translated into a number of different languages. So, those ended up being three pieces of the arms of the study. The pantry had become pretty much the standard of care in all of the facilities we were working in. So, that was one arm. So usual, customary care. And then, we added to that because it was in the sites that we were at, we added a voucher arm as well. And in the third arm, it was a home grocery delivery arm. Those were the three arms of this randomized control trial. All of the monetary amounts were the same for the three arms. So, the grocery bag cost the same as the amount they were given in the debit card, which costs the same as the home grocery delivery pretty much, or it was at least equivalent nutritional content and food content. So, those are the three arms of the study. Dr. Shannon Westin: Great! Well, just cut to the chase and let the group know what did you find? Dr. Francesca Gany: So, we found that after six months of participation, the voucher plus pantry arm had the greatest treatment completion rates, 94%, versus the home grocery delivery, 82.5%, versus the pantry alone, which was 77 and a half percent. So, tremendous differences between these three arms. All three arms saw a significant improvement in food security status but those were the treatment completion rates across the arm. We also looked at quality of life and depression symptoms across the arms at 6 months, and across all arms, patients had fewer depression symptoms in follow-up. And improved FACT-G quality of life scores. But the statistically significant differences were actually found in the pantry and the delivery plus pantry arm for both of those measures. Dr. Shannon Westin: That is so interesting and so exciting to see this type of intervention making a difference for our patients. Was there anything that surprised you about your results? Dr. Francesca Gany: So, the one that was a little surprising was why the quality-of-life results did not exactly mirror the treatment completion rates. And we are assuming that that has to do with the fact that with the pantry, there's a lot of in-person interaction with staff and with the home grocery delivery, actually, because many of the patients found it a little bit tricky to order the grocery deliveries online, they also had a fair amount of staff interaction. Whereas with the voucher, there was less of that. So, perhaps that explains that we're not sure and we're doing a much larger randomized control trial now in which we're going to look at that. One really great finding was that around food choices and healthy food choices with the voucher because we wanted to look at that, we were controlling what we gave to patients with the pantry arm, and we were controlling that to some extent with the grocery delivery, especially because we were ordering with them. But we were very interested for the voucher arm and across the board, people made very healthful choices with the voucher. Again, they all were accompanied by nutrition education, etc. And interestingly, limited English proficient patients and patients who were born abroad had the healthiest food choices. So, this was a great way to intervene with all patients who were food insecure. And we saw that it had a tremendous impact equally regardless of country of birth, language, etc. And great extra finding that there were healthful food choices and that was especially true in immigrants and in folks who have limited English proficiency. Dr. Shannon Westin: Great. It's so exciting. I think though, it brings up the obvious question that seems like a ton of work. So, how do we operationalize this in our clinic? How do we screen patients? How do we work with our cancer center directors or our clinic directors to be able to provide these types of interventions? Sorry, I know it sounds like it's a million-dollar question. Dr. Francesca Gany: This screening is simple. For these studies, we use the 18-item USDA Food Security screener. That's a longer instrument but we wanted to make sure we use that for this study. But in actual clinical practice, the two item screener works. And we are working now on one question specifically for cancer patients that we're finding is also quite sensitive and quite specific, and that does not take a long time at all. We should be screening everyone. We should be screening in an ongoing way. We should be tracking this as a very important patient outcome. What does take longer and which is a little bit daunting to folks is that once you find food insecurity, you need to treat it. And so, we do a lot of work around how to treat food insecurity and how to treat it efficiently. In the end, I actually think that the food voucher is going to be the way to go because it requires less staff time. And people are used to paying for groceries with debit cards, and with cards, and that has not been an issue at all for our patients. And I do think from a clinical operations perspective, from a policy perspective, and from an insurer's perspective, this should be part of the workflow. The vouchers are a really eas…

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    How to Confront Climate Change: A Framework for Change in the Operating Room and Hospital as a Whole. A Conversation with Dr. Anaeze Offodile and Dr. Elizabeth Yates Jun 17, 2022
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    Dr. Shannon Westin discusses the topic of climate change in the operating room with Dr. Anaeze Offodile and Dr. Elizabeth Yates. TRANSCRIPT The guest on this podcast episode has no disclosures to declare. Dr. Shannon Westin: Hey everybody! Welcome back to JCO After Hours, a podcast where we get a little bit more intense, a little bit more specific about articles that are published in the Journal of Clinical Oncology. My name is Shannon Westin, and it is my honor to serve as the social media editor for the JCO. I'm an associate professor at the University of Texas MD Anderson Cancer Center and a gynecologic oncologist. Today, we are going to be discussing a really exciting paper which was published in the March online JCO. It's a Comments and Controversies piece called, "Prescriptions for Mitigating Climate Change-Related Externalities in Cancer Care: A Surgeon's Perspective." I have several guests with me today, none of whom have any conflict of interest. The first is Dr. Anaeze Offodile, who is an assistant professor in the Department of Plastic Surgery, as well as in the Department of Health Services Research at the University of Texas, MD Anderson Cancer Center. He also serves as the Executive Director of Clinical Transformation at MD Anderson. He is the senior author on the paper, so he will have a lot to offer here. But we're also accompanied by Dr. Elizabeth Yates, who has the title of clinical fellow in surgery at the Brigham and Women's Hospital in Boston, but tells me she's a rising PGY 4 resident, which makes it even more impressive that she is already published on the role of the surgeon in climate change. And so, we're so honored to have her with us today to share her perspectives as well. Welcome both of you. Thank you for being here. Dr. Anaeze Offodile: Happy to be here. Dr. Elizabeth Yates: Thanks so much for having us. Dr. Shannon Westin: So, I'm definitely someone that has been interested in climate change for some time, and living in the state of Texas, does what I can to rally the political climate here. But I was really intrigued because I never really thought of it in terms of what we do in the operating room. So, I'd love for each of you to give just a little bit of background on your careers and how you kind of got involved with this idea of climate change and environmental sustainability here in the operating room and in medical care? Do you want to start, Anaeze? Dr. Anaeze Offodile: Liz can start first. Dr. Elizabeth Yates: Absolutely! So, I actually came at it from an interesting perspective, I have always been interested in issues of resource distribution and disparities. And when I was in medical school, I started to think about these issues pretty deeply, especially because my younger brother was at the University of Michigan at the same time as I was, studying Environmental Science for his undergraduate and kept nagging in my ear about this problem of climate change and why I wasn't thinking about it as a doctor. And with my kind of ongoing interest in disparities, I came to realize and become compassionate about the role that climate change will play in driving the existing disparities that we see both nationally and globally. And I realized that nobody was really talking about it yet, at least in the surgical field. It had started to permeate some of the medicine and subspecialties, but really, there wasn't a conversation in our world yet. It became all the more relevant to me because I did see this dual relationship where not only do the downstream factors of climate change, like heat waves and major storms, impact our patients' access to care and their outcomes, but on the flip side, we contribute to climate change, because the delivery of surgical care, particularly in high-income countries, is so energy intensive and so wasteful. And so, I felt like if any clinician has a role in this space to really lead and change the narrative, it would be us as surgeons. Dr. Anaeze Offodile: It's really interesting to listen to Liz's journey to this issue, which affects all of us. I came at it from the micro level, bottom-up level. So, when I was a fellow about four years ago, under the mentorship of Nancy Perrier, we launched and have since scaled, I don't know if you're aware of this, Shannon, so the 'Know Your Costs' program. For the audience, this is a project at MD Anderson where we really try to minimize cost variability and waste in the operating room by providing a feedback tool to surgeons that sort of made them more conscious about the spending directly attributable to disposable supplies, implants, devices in the OR. One direct outcome of the project that we found was that actually narrowing the variability in these disposable instruments, supplies implants surely had no impact on the outcome, but also got sort of the cost structure of what we do in the OR down. So, that's the value-based care proposition. And in doing this work as I dug more into literature, I learned as we so highlighted in the article, my co-authors and I, that actually the perioperative environment is a major driver of waste in the hospital setting. I think that recognition certainly led to this work, which we're very glad that JCO looked upon favorably to champion. Dr. Shannon Westin: Yeah, I love 'Know Your Cost'. My fellows make fun of me, because I always take the electrosurgery devices, they're the cheapest. And they're like, 'Oh, you're using the Costco version!'. And I'm like, 'You know what? We're reducing costs. So, just hold it a little bit longer there, and you're gonna be fine.' So, I was really struck by one of the first sentences out of the gate in your commentary that the healthcare industry accounts for roughly 8.5% of total GHG emissions in the United States, the most in the world in per-capita and absolute terms, I mean, to me, that was so eye-opening within the first few sentences. What are some of the other major takeaways that you hope that readers of the JCO get from this piece? Anaeze, I think we can start with you and then I'd be interested to hear your perspectives as well, Liz? Dr. Anaeze Offodile: So, I will say, a couple of high-level, and I can touch on the sort of specific prescription that we put forward, but I think the big takeaway is, one, is healthcare has a certain moral imperative to keep our contributions to sort of environmental sustainability, greenhouse gas emissions, to control that, there's a moral imperative to this work, right? One, climate change effects are differential. So, the vulnerable populations, like Liz said, tend to suffer the worst. So, when you think about communities and countries in the global south, they bear the brunt of this, not industrialized nations. And number two, our activity directly maps to greenhouse gas emissions. And as surgeons, the relationship is much more direct. So, carbon-intensive procedures like the robot, the perioperative environment, and the supplies, the waste, and the supply chain that sort of feeds into that. So, those are the things high-level that I want to call out. And many ways this paper is intended to start a conversation that will be ongoing amongst the community, the academy, and I'll say in both surgical and medical respect: to what extent do we take ownership of this problem and contribute to the meaningful solutions of the problems? And I can certainly talk about some of the recommendations we put forward, but I think that's the key takeaway. Dr. Elizabeth Yates: Yeah, as not an author, but a reader of this paper. I really thought it summarized the high-level ideas, and really did serve as a conversation starter in the best way. What I really liked, and I try to strive for in my own work at our hospital, and we implement sustainability initiatives, was the perspective that you took coming from more of a cost-saving perspective initially, because I think people have a misconception if they do ever think about sustainability and care delivery, that somehow quality has to be compromised for sustainability - to go green, you have to do less - and that's not necessarily true. And you really highlighted a lot of opportunities in the four domains you emphasize in this paper about how you can change the way your system works, or the choices you make, for the devices you use or the energy supply, without actually compromising outcomes for patients, that we can maintain a high level of quality that makes them smarter choices for our systems to also be more sustainable. And then a lot of the time there are cost savings. It could be a triple win but we just need to put more time and effort into the surgical world thinking about these issues. Dr. Anaeze Offodile: Liz, thank you so much. What we tried to articulate was, there is no trade-off between planetary health and value-based care and high-quality care. I think those two are actually synergistic, and certainly mutually reinforcing. So, that's the one thing we tried to do. I'm glad it came out to push forward. Dr. Shannon Westin: I was joking about our bipolar use and such, but that's really what I'm trying to teach our fellows is that you can do the right work with an instrument that doesn't cost as much. And in this case, the robot is perfect. I was reading that as a robotic surgeon who also does laparoscopy and I thought, 'Gosh! When I'm making these decisions, this is such a trickle-down effect.' And so, I really do think that I'm interested in strategies to offset those things. Because sometimes, for us in gynecologic oncology, the robot is a superior tool as far as visualization and also surgeon back pain and such. But you really have to understand that trade-off or what else you're impacting. So, I guess, what can we do with the framework of this piece in mind, what can the clinical care providers really do across the country to meaningfully address climate change and improve overall healthcare sustainability? Dr. Anaeze Offodile: So, I will talk from the surgical perspective and maybe I'll point to Liz for a broader outlook on this, but we touched on four main buckets or domains of sub-activity. So, one is the OR environment, right? Thinking about the type of anesthetic gasses that we use, thinking about energy efficient lighting, thinking about the heating ventilation AC, HVAC, can we sort of bake in preventative maintenance on a scheduled time, and using things called setbacks. So, for instance, don't have it run overnight when no one is using the OR. For the most part, there are always emergency cases, but when there's low foot traffic, like nighttime, could we not have the HVAC running during that time period. So, some things like I'll say, low hanging fruit that we can do in respect to the OR environment. And as we think about building new ORs in new hospitals, let's bake in sort of an environmental impact assessment as you sort of commissioned these new environments. So, that's one. Number two, the supply chain and thinking about streamlining the disposables, the gowns, the implants that we use, and really thinking about the procurement and sourcing of these things, taking a climate change lens to picking vendors, picking partners, almost sort of requesting an audit for these vendors with respect to how they create these goods that are sort of being engineered for the environment. The third thing is actually waste. And thinking about sort of the amount of waste that comes from the cost of surgical care – Can we lean more towards reusable as opposed to disposables? Can we think about reprocessing devices sort of like, the world is a circular economy now? Can we think about those types of initiatives with respect to waste? And the last two are value-based care, specifically thinking about low-value surgical care, really that's another way of saying activity that doesn't track to meaningful clinical outcomes. So, that activity, if we're to reframe it , creates carbon that worsens our greenhouse gas emissions, but doesn't track to any meaningful benefit to patients' society. So, low-value care, de-escalating that, or de-implementing that certainly could help with our greenhouse gas profile. And lastly, COVID has been a major force in functioning telemedicine. Can we think about telemedicine in a way that optimizes traffic, and transportation, while keeping cost structure down and thinking about greenhouse gas emissions? So, those are the four or five main elements that we've sort of proposed in our paper. I'll say pieces of this can be contextualized in a medical context. Waste can be put in the medical oncology lens as is virtual care, and as is low-value practices. So, that's how we thought about it for this paper. Dr. Elizabeth Yates: It really nicely summed up the categories of areas for implementation. So, I think I'll keep my comments focused, one, on what does it mean to actually implement that kind of work, and then scale back and what can we do, as you highlighted more broadly as clinicians. But as someone who's really started this work, and we initiated what we call 'Watching Our Waste' program across our procedural spaces at our hospital, and working with my mentor, Dr. Winn who's a vascular surgeon has been really beneficial, because having a clinical voice start to push and champion these ideas, is really meaningful. And when it doesn't come from the administration or top down, it feels a lot more homegrown, and people accept it a lot more quickly on the clinical side, rather than an eco-green team being purely administrators and people who work behind desks. You know, having boots on the ground, saying that this is important, and champion ways to integrate it into our workflow without compromising efficiency or quality of care has been really meaningful. And for anyone who's starting these initiatives, I would say the gateway for anyone who wants to really tackle this, I would recommend a waste audit. Just start with your floor, your OR, whatever your clinical area practice is, your outpatient clinic, and see what kind of waste you make in a day. The efforts you put towards that in terms of meeting your environmental services people, meeting Environmental Affairs, going through the trash, understanding what your use of various supplies is, gives you so much information and such a strong foundation as an easy thing to do as a first step and you'll know where to go from there. It'll really guide your next steps. And as you scale out, and if you get more involved in this work, what I've come to find is the administrators are looking for a clinical voice. There's the policy being pushed at a national level, to start really looking at healthcare and its carbon emissions, and there isn't a lot of expertise, and making sure that this kind of effort and these policies and the implementation of more sustainable practices align with clinical care is a priority and a growing one at the hospital level. And they need clinical voices to actually understand how this is going to work and move this forward and in an effective way. So, if you're interested, I would just highlight that this is an opportune time to get involved. Dr. Anaeze Offodile: Can I make one somewhat controversial comment, I hope it's not that controversial. You know, Shannon, as you think about the demographic shifts in the next 15 years, millennials will be the dominant healthcare workforce and the dominant patient population, right? And as you think about awareness, I will say, as you go down in the age levels, I'll say anxiety, apprehension, and more optimism increase as you go down.…

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    JCO After Hours: A Discussion With Veena Shankaran and Scott Ramsey Apr 01, 2022
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    Shannon Westin, Veena Shankaran, and Scott Ramsey discuss the issue of financial toxicity among low- and middle-income cancer patients. TRANSCRIPT The guest on this podcast episode has no disclosures to declare. Dr. Westin: Welcome to JCO After Hours. I am your fearless leader, Shannon Westin, the editor for social media of the Journal of Clinical Oncology, and it's my great pleasure to bring you another episode. Today, we are going to be talking about a paper published in the January 7th version of the JCO called "Risk of Adverse Financial Events in Cancer Patients: Evidence From a Novel Linkage Between Cancer Registry and Credit Records." And none of the participants have any conflicts of interest. I am joined by two amazing people. First, let me introduce Dr. Veena Shankaran. She is a physician in the Seattle Cancer Care Alliance, professor in the Division of Medical Oncology at the University of Washington School of Medicine, and co-director of the Hutchinson Institute for Cancer Outcomes Research at Fred Hutch Cancer Research Center. Hey, welcome. Dr. Shankaran: Hi, Shannon. Thanks for having me. Dr. Westin: I'm so excited to have you. And she's joined by her colleague, Dr. Scott Ramsey, who is a professor in the cancer prevention program in the Public Health Sciences Division at Fred Hutch and the director of the Hutchinson Institute for Cancer Outcomes Research at Fred Hutch. Welcome, Dr. Ramsey. Dr. Ramsey: Shannon, great to be here. Dr. Westin: This is such an exciting paper and so very timely. We've been certainly hearing—I wouldn't say a lot but more and more about financial toxicity over the last few years, I'd say very appropriately. So, let's start with the basics. Let's make sure we level set. Can you educate our listeners on what financial toxicity is and what it means for patients with cancer? Dr. Shankaran: Yeah, absolutely. I can start. Financial toxicity, I think, is a relatively recently recognized complication, if you will, of cancer treatments. And really, I would say over the last decade or so, the literature has just sort of exploded describing kind of the various aspects of this big problem. I think one conceptual model that sort of helps me understand financial toxicity was developed by Robin Yabroff and Reggie Tucker-Seeley that really describes financial toxicity is that trifecta of material, financial hardship, kind of what we think of as out-of-pocket expenses, debt, the money that you pay to get cancer care. The other aspect is sort of the indirect coping mechanisms related to the cost of cancer care, like forgoing treatment, forgoing surveillance, cutting back on treatment-related cost concerns. So, more of the behavioral aspects. The final aspect is sort of the psychosocial-psychological aspect of financial hardship, which is really just the distress related to how am I going to pay for all of this? How is this going to affect my children and sort of our financial well-being? It's a big problem, a broad problem that touches on a variety of issues and also affects families and caregivers too. Dr. Ramsey: I would add that financial toxicity really got into the literature probably seven or eight years ago. The term itself was coined by an oncologist, Yousuf Zafar, at Duke University. He told me he actually heard it from a patient who, when he was describing all the toxicities of cancer treatments, the patient said, "Well, don't forget financial toxicity." And so, that's how the term, according to Yousuf, was coined. He published a series of case reports on patients who experienced financial toxicity. And our group did a study where we linked federal bankruptcy records to the cancer registry and found about a 65% higher risk of bankruptcy among cancer patients. We also did a subsequent paper looking at mortality among cancer patients who went bankrupt compared to cancer patients who did not and found excess mortality. So, we do have evidence that severe financial toxicity, i.e. bankruptcy can actually affect survival. And now, since that time, there have been other papers that have looked at quality of life, adherence to therapy and have found those as adverse impacts as well. Dr. Westin: Well, that makes sense when you're looking at that trifecta. I hadn't heard that. That was really educational for me. But looking at the ways that patients cope with this issue and actually foregoing their cancer treatment. And I think I've certainly heard about that in terms of like diabetics, like maybe taking their insulin every other day versus every day. You could see where we would see something similar in a patient with cancer. Do we have any data to know how common this is across our patients with cancer? Are there specific cancers where we see this more commonly, or is this kind of every cancer type is at risk? Dr. Shankaran: The non-adherence aspect? Yeah, I mean, I think in the studies that we've done, it hasn't been reported terribly commonly by patients. So, probably on the order of 7 to 10% of patients in the studies that we've done, though you have to imagine it's much, much more common and prevalent, particularly in cancers where people are taking oral cancer therapies, and these tend to be associated with a lot of high out-of-pocket costs, these drugs that go through the prescription plans. Actually, I mention a few papers that have been published over the years by Stacie Dusetzina, who's a wonderful colleague of ours, who's looked at how changes in copay, not even by a lot of money, but just slight increases in copays for these oral cancer medicines can significantly impact not only adherence to prescriptions that have been built, but whether or not people actually fill their prescriptions. Dr. Westin: Wow, that makes sense. So, what led you all to this particular work that's described in the paper in the JCO? Dr. Ramsey: As I mentioned, we had this bankruptcy study where we linked federal bankruptcy—and bankruptcy is an extreme form of adverse financial outcome. And I think our interest was, well, what happens with less extreme forms of adverse financial outcomes. And that led us, I think, to search for ways to characterize less severe forms, and Veena and I have done surveys over the years where we've asked patients, but it's very hard to define something that's on a population-wide level. So, we came to this idea of using credit report data and that led to a very long journey—I think it was about a two-year journey—to get one of the credit reporting agencies to agree to allow us to link their database with the cancer registry in our state. Dr. Shankaran: I always laugh when we talked about the study, because I feel like we've spent years—I mean, two years might be right, Scott, but in my head, it feels like closer to a decade—just trying to make this happen, because it was a long process trying to link the credit records to the cancer registry data. And to add to what Scott already said, part of our motivation for doing this is that there have been a lot of studies that have used survey-level data and where we've asked patients to describe what their financial burden is, and it's substantial. Sunny reports anywhere from 30 to 75% of cancer patients report financial hardship. These surveys, they're subject to interpretation, whether patients understand the question being asked. There's bias in terms of who participates in a study in the first place. And so, our feeling was, can we be a little bit more methodical in trying to understand what the impact is and looking at measures that—almost everyone has access to credit on some level or the other. So, it's a very kind of standard way of looking at people's financial status to use credit data. So, that was our goal in trying to understand, as Scott said, at a population level, what is the impact? Dr. Westin: One, that's brilliant, and that makes total sense. And anytime you can get population-level data, as opposed to the kind of trying to get people to answer questions and give you details, is always ideal. But I loved your aside about the two-year process because we have trainees listen to this or young investigators, and it's always good for them to understand sometimes the amount of time that can come—and this is obviously a really high-impact paper and so important, but even when we're doing just simple retrospective studies, the amount of time sometimes that goes into it, I love that kind of background, just to tell people it's okay if it takes a long time. It's still going to have an impact and still going to be important. That's a great segue into just really a review of some of the methods that you used for the study, what were your primary outcomes, and how you laid everything out. Dr. Shankaran: Yeah, so we essentially went to the credit agency—TransUnion, in this case—and asked them to provide us with a long list of credit attributes that we were able to link with the cancer registry. And there were many, many items that they gave us of credit data, of which we went through them all and really tried to understand the financial literature, the landscape of what credit measures are important, what indicates kind of this spiraling down towards bankruptcy, what happens first, what happens next? And so, with a lot of guidance from the economic literature and the folks from the credit agencies, we defined three categories of financial hardship that we looked at. The first one was what we categorized as severe financial hardship, which we described as inability to pay the bills as evidenced by third-party collections or charge-offs, which are basically kind of like collections where it's not worth it to the creditor to actually collect on it. The next is the kind of more of the impacts on or events that suggests potential action against a person's property. So, tax liens, delinquent mortgage payments, on to the most severe kinds of financial hardships, actually losing a home through foreclosure or repossession by the bank. And so, we took individuals with cancer, matched them by age and sex to individuals without cancer, and essentially looked to see how common these events were in the cancer population versus the non-cancer population, and then controlling for confounding factors that could also influence this association between cancer diagnosis and financial hardship. We found that cancer patients had a significantly higher, 71% greater risk of adverse financial events than individuals without cancer. Dr. Westin: That's so interesting and then can you take us through the bottom line of what y'all found? Dr. Shankaran: Well, the bottom line is that when you take people with cancer and similar people without cancer, cancer diagnosis has a significant impact on risk for major credit events that are likely to have, we think, long-term impacts on people's financial health. And that's a problem, and this does not seem right, and it should not happen that people who develop a disease, for the most part, no fault of their own. I mean, this is a major health shock that leads to potentially severe and long-term effects on people's financial health. Dr. Ramsey: And overall, the excess risk for any of these adverse financial outcomes was about 71% higher for the cancer patients compared to the non-cancer patients. Dr. Westin: Wow. That's an incredible number. I read your paper, but still hearing it just is incredible. So, what can we do? What recourse do we have here? How can we help support these patients? Dr. Shankaran: Well, I think you touched on this a little bit earlier, Shannon, which is that, how do we screen people for financial risk in the first place? How can we identify those who are most likely to develop these adverse events? I wouldn't say that screening everyone's credit score and credit status is really feasible at the clinic level, but our hope is to use these data along with other studies we've done to see if we can develop risk scores to try and predict those who would be most likely for these kinds of severe credit impacts. I think, in addition to screening, what we're really thinking about a lot, and I'll let Scott add to this in a second, but is what can we do at the clinic level to help avoid financial hardship. And we've been doing a lot of work on developing financial navigation interventions, which is essentially kind of like patient navigation, where you're trying to get people to their appointments and get them there on time, but really instead of navigating the logistics, navigating more of the financial aspects. So, hooking them up with resources for copay assistance or lodging, transportation, in the hopes that kind of comprehensively addressing all the financial aspects of care can help, ultimately, people stay on treatment and live better, have better outcomes. Dr. Ramsey: Yeah, and I'd add that I think the immediate things that we can do for patients—Veena outlined very well—screening people to find out people who are financially fragile, getting those folks to financial counseling services so that they can adjust their spending and saving so that they can withstand what could be months or years of excess costs due to cancer. It's worth noting that a lot of people don't choose to enter cancer, and they come with the financial situation they have, and some are well off, and some are very tenuous. And in order to prevent people getting into a disastrous situation, having someone look at their current situation is critical, and we've worked with a bankruptcy judge who says often it's the people that are kind of in the low or middle income that are at the biggest risk for falling because they have expenses that we all have, cable bills and car payments and everything else. And they don't think about adjusting those when they have cancer because they don't think this is going to be an issue, and pretty soon the added expense of paying for cancer care and the loss of work and the caregiving needs pile on to all the other expenses, and before they realize it, they're in serious trouble. It's much harder to get out of trouble at that point than to try to adjust your expenses to accommodate what's going to be a long journey for many people with cancer. Dr. Westin: What about more globally? I think that you addressed kind of at the clinic level. What about from an advocacy standpoint? Drug charges are the elephant in the room here, right? And I think one of you mentioned copays. I feel like we do quite a bit of targeted therapy in GYN oncology with PARP inhibitors and now lenvatinib and pembrolizumab, and it's just such a wide range. I have patients that have $0 copays and patients that it's going to be $2000 dollars a month or even more. So, how do we level that? And how can we advocate to our lawmakers to try to reduce the bonkers costs right now of targeted therapies and novel drugs in America? Dr. Ramsey: Well, I think it'd be easy to blame the pharma companies and the high price of drugs, but it really is a multifaceted problem. And I personally think we do need to have some policy discussions about what we can do to address this because it's so prevalent. I should add that it goes beyond cancer. People with other chronic diseases surely suffer the same problem. But yes, the drugs are very expensive. But there's also the insurance plans have copay and deductible structures that really are beyond the means of many Americans. I mean, as we mentioned, in the paper, a federal reserve study found that only 40% of US households could afford a $400 unexpected bill in their average life. And we know that's going to happen in probably the f…

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    JCO After Hours: A Discussion With Virginia Sun Feb 21, 2022
    Show notes

    Shannon Westin and Virginia Sun discuss the JCO article "Patient-Reported Outcome-Based Symptom Management Versus Usual Care After Lung Cancer Surgery: A Multicenter Randomized Controlled Trial" TRANSCRIPT Speaker 1: The guest on this podcast episode has no disclosures to declare. Dr. Shannon Westin: Hello everyone. This is Dr. Shannon Westin, your JCO Social Media Editor here with another episode of Journal Clinical of Oncology After Hours Podcast. So excited to bring you in depth discussion on some of the amazing studies and manuscripts that have been published in the JCO. I am joined today by Dr. Virginia Sun, who's Associate Professor in the Division of Nursing Research and Education and the Department of Population Sciences Education at City of Hope. Dr. Shannon Westin: She has 17 years experiences as an oncology nurse, four years experience as a nurse practitioner, before becoming a full-time nurse scientist. And her research program is meant to develop and test interventions to improve patient and family-centered care and outcomes, specifically on cancer surgery and cancer survivorship populations. And what better person to have with us today as we're discussing the article, Patient Reported Outcome Based Symptom Management Versus Usual Care After Lung Cancer Surgery, a multi-center randomized control trial by Dr. Dye and colleagues. So welcome, Dr. Sun. So excited to chat with you today. Dr. Virginia Sun: Thank you so much for the opportunity to be here. Dr. Shannon Westin: So let's get right into it. I think this article caught several of the editors' attention, because it really is an exciting [inaudible 00:01:42] into how we might take care of patients after surgery. And as a surgeon myself, I was completely intrigued so I can't wait to get your perspective. So let's start off first, the author's note that patients with lung cancer have a high symptom burden after surgery, as a non lung cancer expert, can you walk those of us through a typical post op course and some of the issues that might be experienced by these patients? Dr. Virginia Sun: Sure. So, I think symptoms is something that probably all of our patients who just underwent surgery experience. But for our patients with lung cancer, some of the common symptoms would include pain. I think pain is one of those universal symptoms that many of our patients experience after a procedure. But particularly for this population, they would also experience shortness of breath, of course, because anatomically there were certain parts of their lung that were removed as part of the procedure. Dr. Virginia Sun: Cough is something that they would experience regularly as well. And I think sleep disturbance is one of those general symptoms that all of our patients may experience. And also just emotionally, the anxiety perhaps, and the stress may continue probably in the immediate post op timeframe when they just transition home. And then also the functional decline, also happening along with the fatigue. Many of our patients, although we get them up and out of bed as soon as possible, as a nurse, I know that's generally sort of our responsibility in the post-op recovery period. Certainly fatigue and the functional decline is something that our patients will experience in this population as well. Dr. Shannon Westin: Certainly many of those are universal across what we see in patients in the postoperative period. But I know personally, and I'm sure you could speak to this as well, we're busy post op, right? Especially whether you're rounding in the hospital, or you're seeing patients in post op in the clinic, I don't know how much we really get super deep dive into a lot of these symptoms. So I think that's what makes this work so important. So I'll just have you, if you could, briefly discuss this study design that was performed by Dr. Dye, and Dr. She, and their colleagues. Dr. Virginia Sun: Sure. So the intervention is really patient report outcome based symptom management. And this is done by way of alerts and completion of the MD Anderson Symptom Inventory, which is very well known symptom inventory tool well validated within this population as well. And also when patients share that information after surgery, and while they're recovering in the hospital, that will prompt an alert. So there were predetermined thresholds by way of the symptom score. So if a patient on the trial that reported a four to 10, which is generally a moderate to severe intensity for a symptom, and that will trigger an alert to the surgeon and the surgical team for management purposes. Dr. Virginia Sun: Now, in terms of this trial, the investigators chose several very relevant symptoms to focus on for this population to assess. And that would include pain, fatigue, cough, shortness of breath, and sleep disturbance, although the MD Anderson's Symptom Inventory does cover more of symptoms and beyond those as well. And in addition, I think, to the surgeons in response to the alerts, there were also other management, I think, that were triggered from the alert itself. So there may have been other services that were triggered as part of the intervention. But the first line of response to the alert were from the surgeons for this particular trial. Dr. Virginia Sun: So the patients after they were discharged home continued to provide, I believe, twice weekly symptom information by way of completing the MD Anderson Symptom Inventory. These are all done electronically, and then the alerts I think were continued. And this was done up to four weeks post discharge. And they also did include on data that's collected in the pre-op setting, I think, one baseline, and then after post-op there were several data collection time points. In the hospitalization period I believe it was a daily symptom report, and then after they return home in the first four weeks, it's I think twice a week. Dr. Shannon Westin: I think it's perfect to have a way to automatically alert the surgeon and their team. Because again if we just don't have time to engage on that level with the patients on.... Can you imagine every day your team having to call? Just the amount of operationalizing that that would take, it would just be bonkers. And so I love this because I'm already kind of thinking tick, tick, tick in my mind, "Okay, how would I incorporate this to the patients of mine that are in the postop setting?" So tell us, should I do that? What are the benefits of incorporating patient reported outcomes into the post op care? And then of course, were there any negatives to the strategy? Dr. Virginia Sun: Sure. I think we have quite a bit of evidence now by way of patient report outcomes guided management. This was done in many different settings, I think primarily starting in the chemotherapy setting, but now more and more in the surgery population as well. And so I think first and foremost, it's a great way to make care more patient centered, right? Everything is driven by the patient's needs. And everyone may be presenting different symptoms at the same time, even though there are common symptoms that we may see from patients with lung cancer after surgery. But it makes it really personalized and relevant to each of the individual patients. Dr. Virginia Sun: Another way I think about it is sort of the proactive versus reactive approach of postoperative care. In most settings, perhaps, I don't want to say all, but certainly in most settings our approach to postoperative management, while the patients are at home and in the community, I think are more largely reactive. So most of the time we may... We have information that we give to patients, "If you are having any symptoms, or you're meeting any of these criteria where you have a fever or anything like that, please call us." And many institutions may have a phone number that patients can contact during business hours or after hours. Dr. Virginia Sun: But this approach gives patient an opportunity and places to contact us when they're experiencing challenges. But it relies on the patients, right? So it's still the patients who need to remember that, "Oh, I need to call when I have these things." In most situations unfortunately, it may be a little too late. We may get a phone call from patients or families when it's kind of at a crisis mode and we need to bring them in or they need to be you readmitted. So I think the patient reported outcomes approach to me is more of a proactive way. Dr. Virginia Sun: The patients share their information with us at certain time points, during the perioperative setting or postoperative setting. And the healthcare team and oncology team, the surgical team, somebody on that team is the one who is monitoring or getting the alerts from this team, and then we proactively contact the patients to perhaps assess and manage. So I think another way that I kind of tend to look at it is that, the responsibility is really on the healthcare team to sort of act on the patient's information rather than sort of more of the reactive approach, where we wait for patients to call us when they're having pain issues, when they're having sleep disturbance issues, or shortness of breath issues. By that, it kind of makes also for a more patient centered approach too that patients have a way communicate with us and they know that someone is on the other end that will be reacting. Dr. Shannon Westin: Well, and I think some of the symptoms that you're covering, I feel like patients will call for, "Oh, gosh, I'm really short of breath, or my pain is uncontrolled." People feel really comfortable with that. But some of the other things like, "Well, I'm not sleeping that well," or some of the other things that could be precautious to a worse issue, exactly to your point, they may not call early on, and then you get behind the eight ball and you're in a really serious situation. Dr. Shannon Westin: So I do. I like this and I like that they know, "Okay, there's someone on the other end of this. I'm not just shouting my issues out into the ether. Someone is going to hear this and respond." And then conversely, the care team is prepared. They know, "Okay, these are coming in and these are the triggers. These are the thresholds at which we're going to mobilize what. Okay, we're going to get pulmonology involved for this, so we're going to bring the patient into clinic to have them look at a wound," or whatever. I think to me, this makes so much sense. Do you see any negative? How's the burden on the patient, I guess, is one obvious question. Dr. Virginia Sun: From this trial, we see that the investigators did assess and try to examine sort of the burden on both the patients, and I believe the surgical team as well. And the patients were very favorable in their response in terms of the system, because it's another way for them to communicate with the care team. Especially for our surgery patients who were before surgery at home, right? There may be had been some visits, but they're mainly out of the community, and in the home setting. And then of course, when they're discharged after. Dr. Virginia Sun: So one of the things I think we should think about is, this is of course.... And this is a great study but it's done in, I would think, a different healthcare system. So this is a study out of China. And so is it replicable, perhaps, within the United States Healthcare System, where there may be differences in terms of when we get patients into the OR versus sort of the care that's provided after. And who will be monitoring this information? It's great to see that the surgeons, and I think the data from this trial shows that on average, it took them three minutes to manage some of the symptom alerts, which is great. Three minutes, it's actually really, really amazingly quick, right? Dr. Shannon Westin: That's incredible for that. Dr. Virginia Sun: I know. Dr. Shannon Westin: Well, which Is great. Dr. Virginia Sun: But is it possible for example, within a healthcare system in the United States? And of course within the United States different healthcare systems have different systems too. And so it's identifying who are the people that are going to be receiving this information, and then are there resources for them to be able to react in a timely fashion? And then communication processes in place with the surgeon and the surgical team, if there is a need. Because I think that would be helpful in terms of these types of information, these types of trials, being helpful for surgeons in surgical teams to make decisions about care. Should we be bringing the patient in a little bit earlier, for example, for the first post-op visit or do we need to see them a little bit more often? Dr. Virginia Sun: The other thing I think that would be very important for us to think about, is the digital health and the digital technology disparities. Technology is great. Being able to capture symptoms in a remote fashion electronically and in a relatively quick fashion is great. But we also, I think, need to be mindful of the fact that, what is the comfort in terms of using these kind of programs and devices, and does everyone have access to this? During the pandemic we've heard a lot about Telehealth. We use Telehealth quite often. And Telehealth has great potential. But Telehealth and digital health can also create disparities. And so, I think we just need to be mindful of the population. And perhaps be mindful of the fact that not all patients and families will come with the knowledge in relation to using mobile applications, or technology based programs. And just have those support systems in place, so that we can make things at equitable, right? And that everyone will be able to access these kind of systems to communicate with their surgical team. Dr. Shannon Westin: That's a great point. And I could see something around the fact that for the patient population that maybe doesn't have the devices necessary, needing to kind of lend out devices to the patients, and make sure that the nursing staff or medical assistance can counsel the patients. Then they should walk them through the process. So yeah, I could see where that would be a place where making sure that it was generalizable to the population here and equitable will be essential. The other thing, and this may be completely off base is, for us and I think for you all as well, we use quite a bit of enhanced recovery. We have a pretty elaborate enhanced recovery program request. Really all of our surgical services. And I noticed that wasn't something that was mentioned in this particular article. I don't know if that's something that they were doing. Do you think that that would have an impact in any way on these findings, or if there's a way to incorporate this into some type of enhanced recovery pathway? Dr. Virginia Sun: I think definitely. Perhaps the more long-term, if there is a need to do more long-term remote monitoring when patients are out in the community, or more frequent timeframes in terms of follow up. A lot of this work can also be thinking about what does the data mean? And how can this data not only drive sort of the symptom management piece, but is there a way for us to utilize this data perhaps at the very beginning, as part of that ERAS program, right? In terms of being able to identify those who may need a little bit more communication, or monitoring after they're discharged home. So I don't see this as replacing the ERAS program, I see it as something that could potentially enhance, and perhaps really be able to bring in that…

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