Developing a Decision Support Tool for Individuals with Peritoneal Surface Malignancies (PSM) – Dr Godfrey (2024)

Dr. Godfrey 0:00
Hello everyone, thanks so much for joining tonight. I just want to really thank you for your time to come listen to me gababout my work. I’m working on this initiative that is targeting making a tool to improve the decision making experience that people with cancer have, as well as their loved ones who participate with them in those decision making experiences, when it comes to deciding whether or not to have cytoreductive surgery. And before I start, I want to say that I’m here today because your perspectives, your experiences, are really the important part of what I’m doing. That’s why I’m here. That’s why I’m doing this project. And so I’d like to invite you, as we get started, to think about ways you think we as a care team could help your decision making processes and conversations and experiences better and more confident, and better for your well being. And there will be a link to take the DECISIVE survey at the end, and that’ll be shared through the Perimets neighborhood.

Dr. Godfrey 0:59
So I’m going to share my screen now with you guys. A lot of the material I have tonight is material that Dr George, Manju, wanted me to give you as kind of background, a state of the art, give you some updates on where research is and Peri Mets. So we’re going to spend some time on that, and then I’ll transition into what my work is about. A couple of disclosures. First, this project is supported by the Bucksbaum Institute for Clinical Excellence at the University of Chicago. They gave me a grant to do this work. They’re focused on ways to make the patient and doctor experience better and and have better outcomes for patients. Second, I am a surgery resident, so that means I am an MD, but I am a physician in training. I’ve only been a clinical doctor for two years, and then I’m in my second of two years after that of academic work. So I’m not licensed to provide clinical advice independently, and I’m not what would be called a colon cancer specialist by any means. I am still in my general surgery training. It’s my research expertise that overlaps with this space, and is why I’m here today with you guys. Finally, I’m not going to share any patient or surgery pictures. I do have some artist renderings of anatomy and surgery in this presentation, so I just wanted to make you aware of that before we start. I just want to briefly thank all the people who helped bring me here today to talk to you guys. Thank you so much to Dr. George for helping me set this up, to Megan, to the COLONTOWN crew, there’s been a whole village involved with getting me here and getting this project here, A lot of patient advocacy organizations and a lot of really wonderful mentors who’ve spent time with me. And finally, I’d like to acknowledge my patients who have been so generous about sharing their stories, as well as my friends whose lives were affected by cancer in various ways, who also shared their stories with me and inspired me to to want to do this.

Dr. Godfrey 3:05
So I already know a little bit about all of you guys. I know you’re all here because of some connection to Peri mets, but I’m so I’m going to reciprocate, and I’m going to tell you how I ended up here studying PSM, PMP, colon and appendix cancer is my area, and as I just mentioned, I’m really early in my career. This isn’t a very long story, but briefly, I was a Texan for 24 years. Now I’m a surgery resident in New England. So growing up in San Antonio, these are two people that have been really important to me, shaping my health career journey, who has type one diabetes, and on the right is my grandmother, who has since passed away of heart failure. But I spent much of my childhood sitting in hospitals and doctors offices with them, and some of the most impactful experiences of my youth were hearing the bad communication that we as providers are often guilty of and having our care teams not understand our needs and priorities, or just telling us bad news in a very unhelpful way, and all of those things inspired me to be what I didn’t see and devote my career to making those interactions better. So then I went to Houston, Texas for college and med school, and that directed my life in a lot of really important ways. From an academic perspective, it’s the biggest medical center in the world. I got great exposure to these rigorous, innovative minds in medical science, and from the personal perspective, I made a lot of life changing friendships, many with other scientists and doctors who still inspire me today. In the top picture actually a whole table of doctors who helped make me what I am today, but also with a lot of people who lived with cancer in every sense, both of the people close but in the picture on the top are friends of mine whose lives were affected by cancer. And many of them in the bottom picture as well, and I learned a lot from their cancer journey. Some of these folks are still with us. Some have died, some have relapsed, some have had more rounds of treatment, but all of them taught me some really fundamental truths about how they navigated living well with cancer, and I learned from them that one really important thing that they needed their doctors to do is to listen and support their life goals, not just numbers and probabilities, like helping make treatment work around life events, family priorities, meeting their goals of care, not just necessarily expediting or fast tracking that you get all the chemo on by such and such due date, it’s about a person as a whole, and everyone has a unique story and unique needs.

Dr. Godfrey 5:49
So then I took these lessons with me, when I moved up to Yale, I moved on Memorial Day during the height of COVID, one of the very first attendings I worked with was Rachel Greenup, and she is the head of our breast surgery division. She’s also a really wonderful thinker and clinician who focuses on turning compassion into both action and science. She’s a world expert in decision science and decision satisfaction in cancer surgery. She also models for me being brave about asking hard questions in straightforward ways, and also asking straightforward questions in very nuanced ways, like how to help people understand and cope with the financial burden of cancer care in a way that doesn’t disempower them, or understanding how decisions can better serve priorities that are hard to measure, like peace of mind. So as I progress through my first two years at Yale, another really big thing happened, which is that Dr Kiran Turaga, with whom some of you might be familiar, came to Yale from UChicago before Dr Turaga, Yale was not doing an active cytoreduction and HIPEC program. He got here midway through my second year, and he quickly started a high volume multi disciplinary program, including forming what we call the Peritoneal Surface Malignancy or PSM Consortium team. And this was a group of residents and students who were passionate about solving the problems in PSM that he assembled over the course of just a couple of months and then deployed to move forward the state of care and PSM. So I joined this team, and I also joined with Dr Greenup to learn more about her revolutionary techniques. So this project reflects how I’ve merged the two. We started by talking about a lot of the problems in PSM right now. So clinicians nationwide have really different backgrounds and beliefs about PSM and PMP. And for those of you who haven’t heard the term before, PMP refers to the appendix form of PSM and some subset of the colon form, it just means a sort of mucinous cancer in the abdomen. Many clinicians throughout the nation, really the world, but we’re obviously, we’re focused on what we can reach, are not aware of the differences between kinds of PSM, PMP, they’re not always aware of recent treatment offerings, and some don’t know about the role of surgery at all, or don’t believe it can be helpful. For this reason, a lot of national trials and organizations don’t address patients with PSM and PMP. Having PSM is often an exclusion criteria for trials, and a lot of national guidelines just don’t include clear recommendations for it. And then thatleads to the third problem, which is that surgery residents like myself do not get systematic education about PSM and PMP, which exacerbates the other problems.

Dr. Godfrey 8:51
What we did with this consortium was we formed a group of every kind of physician that is usually involved in PSM care. So that ended up being over 230 experts in various fields of cancer care, 40 trainees– so residents, students, fellows, and then advocacy groups like COLONTOWN, that could help us involve patients in highlighting their perspectives and needs as we went through the process of studying how to improve PSM care. So together, we created shared recommendations and consensus guidelines. We created a shared curriculum for residents, and we also created shared resources for physicians taking care of PSM, so that we can see how other people are taking care of PSM and use their strengths to strengthen all of us collectively. This is an example of one of the guidelines that we made. It’s the guideline for colontumors. What it does is illuminate for people taking care of individuals with PSM, what steps to take when, including when to do systemic therapy, when to think about surgical options. And how to diagnose it at the beginning and how to surveil it or follow it at at the end of treatment. And we did this for seven total manuscripts over six disease types.

Dr. Godfrey 10:15
Of course, this is all just a start. This is what we’ve been doing for the past year and a half, and we’ve made some progress, but the work, very clearly, is not done. To give you a sneak peek of what we’re doing as consortium members, first, we’re working towards coordination and updating of other national and international guidelines so that this information and these recommendations can get to people who are less familiar with the field and less familiar with the needs of people with PSM. We’re also finding a permanent home for those guidelines to live and be updated and maintained, as well as our educational resources. We’re working to advocate from the physician level for better access and coordination for national clinical trials. We’re working right now on building a coalition to gather people’s information and bring more patients on board to be involved from their end. And then we’re also working on a lot of specific projects that are inspired by the gaps and knowledge that have been going on for a long time, but that the consortium has helped shine a light on. So one area of that is studying exactly what chemotherapy works, for which people. This can be on a personalized level, or in the more general, peritoneal tumors versus other tumors, where exploring the causes of cancer and the cause of PSM metastases, by studying how other conditions appear to occur at the same time and other health patterns and characteristics of folks with PSM. We’re also doing a lot of genetics work, including implementing AI techniques to study things that previously we just had too much data coming out of these new methods that have been designed over the past decade for us to understand it. So AI is helping us do that. But this all leads down to what DECISIVE is about, which is focusing on patient and caregiver reported outcomes and quality of life. And that’s something that’s been lacking with this community, and I’ll go more into that in a little bit, but first I’m going to take a step back for a moment.

Dr. Godfrey 12:16
I’m going to talk a little bit about the basics of colon cancer that Dr. George wanted me to touch on. It’s a refresher. I’m sure most of you are very familiar with all of this, and nothing I tell you,will be totally new, but it’ll help us as we navigate what I’m interested in doing with DECISIVE. So this is a cutaway version of what the digestive system looks like. Our large intestine, obviously, is what we’re worried about right now, the colon. There’s a zoomed in version of the colon. I thought this was a helpful view, because you can see where all of the blood forms these looping swirls. And the green dots are lymph nodes, and those show the most common pattern of how cancer spreads. So briefly, what is colon cancer? It’s surprisingly hard to define in general what cancer is, but the most universal definition, as all of you are familiar, is when cells grow out of control, they lose their context, they lose the structure they’re supposed to have. They stop doing the function that they’re made to do. In colon cancer, specifically, there’s certain patterns of mutations that we think lead to cancer. The most common is a gene called APC mutates, and this causes some disturbed or dysregulated cell behavior that seems to contribute to a gene called KRAS getting mutated. And then P 53 is sort of the last line defense. It’s a gene that helps maintain DNA control, so it helps eliminate cells that have damaged DNA. But when you lose that particular gene, sometimes that’s when cancer finally really takes off. And so those genetic characteristics combined with some cell damage and some changes in the immune system seem to all work together to cause normal checkpoints, normal defenses to fail. Or sometimes the tumor even manages to hack into those defenses and use them on its own behalf to invade previously healthy tissue.

Dr. Godfrey 14:20
I think it’s helpful when we’re talking especially about peritoneal disease, to look at the layers of the colon and kind of understand how the path reports relate to what peritoneal disease means. So this is a cutaway view. The mucosa is the inner layer of specialized skin type cells that line the colon. Those are the parts of the colon that process and absorb our nutrients. The dysplasia, which is disordered growth, that’s the starting point of cancer, generally starts in the mucosa. And if it starts there and it stays there, it’s what we call a TIS, or in situ tumor. So that is not invasive disease. That’s something that can be managed, often with colonoscopy, sometimes, if that doesn’t work with surgery, but it isn’t disseminated cancer. Then there’s submucosa, and that has the tissue that supports that mucosal layer. It has the blood vessels. It has lymphoid or immune tissue. If there’s tumor in that layer, it’s T1. Then there’s a muscle layer called the muscularis. It’s this orange- red layer that would be a T2 tumor if it reaches there. And then there’s the serosa, which is the connective tissue that surrounds everything. And that would be a T3 tumor. When we start getting into peritoneal disease, we’re talking about somewhere ranging between a T4 and an M1. A T4 tumor is all the way through the wall of the colon and touching the lining of the abdomen, but it’s only involving a part that’s directly connected to the original tumor. When it gets beyond that, that means it’s spread to the peritoneum, and that’s an M1 if it’s metastasized, to t4 if it is not.

Dr. Godfrey 16:05
So what is the peritoneum and how does cancer get there? Again, this is probably the same old song and dance you all have heard before, but about five to 15% of people with colorectal tumors eventually have some peritoneal involvement. What I was talking about T4 to M1, is direct extension spread. So that’s the tumor keeps growing. It’s reached to the surface of this teal lining that you see in this picture. Everything in the abdomen is lined with a sort of very thin film. It’s sort of like our skin, but even thinner. And when it spreads directly, that’s direct extension. It can also do what we call metastasize, which means the tumor may have perforated. The cells from the tumor might spill during surgery. That’s one way that we believe it can sometimes spread. And it can also spread through the lymph nodes, just as cancer can do to other parts of the body. This is the second most common place to have spread by some counts, we’re not entirely sure, because of when it arises, and it can be hard to detect. It’s less common than the liver. And when we think about peritoneal mets, we think about synchronous Mets, which means we discovered it when we diagnosedcancer, or metachronous mets, which come about later in your course.

Dr. Godfrey 17:24
So PSM is a unique challenge for diagnosis and treatment, and one of the questions that I want to ask you as part of the DECISIVE study, which those of you who take the survey will see, is how that process was for you. It can be very difficult for us as doctors to anticipate that it’s happening, and that’s because of one figure of speech that Dr Turaga has used a lot when he explains this to me is called grains of pepper. Peritoneal spread of cancer is like grains of pepper being sprinkled over this area. So the tiny, little, single cells, or handfuls of cells, tiny grains of cancer, like grains of pepper, coat the inside of the abdomen, and so they’re very, very small, but they can cover a fairly wide area. CT scanners and MRI scanners, really, any machine we have, the smallest thing they can see is about two to five millimeters, which is much smaller than those grains. So PSM can only really be seen if it’s advanced enough that it started to grow from that grain of pepper to that two centimeter nodule, or if we can see it during surgery. And once it’s there, it’s hard to treat, because it’s hard for the chemo that can work on tumors that are in the colon, in the liver, in the lungs, it’s hard for the chemo to get into the peritoneum. It doesn’t have very many blood vessels, and it also has something we call the peritoneal plasma barrier, which is just how the way cells grow, form a sort of filter between the compartment as what we call it, of our body that has blood vessels that carry the chemo, and the compartment, that’s sort of where the organs are floating. We also think that PSM has a unique genetic fingerprint. There’s people that are focusing all of their efforts on studying exactly what those genes are, because we believe that it could affect what chemo can do to the tumor once it gets to that tumor. But what this leaves us with, because we can’t really get chemo to the tumor, is performing cytoreduction and then applying chemotherapy from the inside so that it doesn’t have to get through that barrier.

Dr. Godfrey 19:41
So I’m sure most of you have heard of this, or have even had it, and know the process really well. But for anyone who wants a refresher, I want to go over this process. Cytoreduction just means removing cells. What it means in this context is that in a person like this image shown at the right, that has all these yellow nodules of cancer, they would be removing all of those nodules and also removing the lining of the abdomen, that was shown in the teal on the last slide. It also means removing affected organs where cancer is too stuck down to take it off, that’s usually removing part of the colon and rectum, but can also involve parts of the small bowel, the stomach, the liver, the bile system, usually the gallbladder, but sometimes other parts. The diaphragm, which is your breathing muscles, and the ovaries and uterus, depending on whether they’re involved. And in some people, depending on where the cancer is that also means getting an ostomy and even abdominal wall reconstruction, which means we have to take some of the muscle away. We have to provide a way to reconstruct that. And where we go from there is, in many cases, depending on the surgeon, depending on other factors, like the institution and whether any studies are being done, some people then administer intraperitoneal chemotherapy. And that can include any variety of ways of delivering chemo, but it can be heated chemo that’s flowed through the abdomen during surgery. It can be aerosolized chemo that’s pumped into the abdomen. There’s a small number of places that are doing this. It’s still being studied because it’s a new technique, but there are places that do it. And then there’s something called catheter based IPC, or EPIC, which flows the chemo into the abdomen after surgery through a catheter that’s left in place for a few days, two weeks.

Dr. Godfrey 21:43
I did want to touch on t4 tumors, specifically. Dr. George mentioned that this is a topic that comes up a lot, and I found when I was explaining how the peritoneum is involved, this is a complicated topic. T4 tumors do involve the peritoneum, but they aren’t always what we treat as PSM, even though they do involve that structure. So what does this mean for how T4 tumors are cared for? Well, t4 size, regardless of whether it’s in the peritoneum or something else, is generally considered a high risk feature. Systemic chemotherapy is indicated in almost all cases of T4 tumors and sometimes even radiation, if the tumor is touching something that’s what we call a fixed structure that radiation could potentially treat. But this is completely individualized depending on the characteristics of the tumor. But regardless, surveillance is going to be more intensive for people that have T4 tumors, because T4 automatically moves you from stageI into II or III, regardless of other characteristics, and that will include CAT scans, tumor markers and other blood work. One question I get a lot about T4 tumors in general, is the question of whether prophylactic cytoreduction and chemo is something that we should be doing for this. This is also a complicated question. Right now, it’s not recommended outside of a trial. There are some studies that looked back at past patients and how they had done, that said, Well, some people who got prophylactic cytoreduction seemed to do better. But there’s a lot of limitations to retrospective studies, because all we know is that this person, somebody decided they would do well with surgery, they got surgery, and they did well, but that doesn’t tell us about the people that didn’t get surgery. That doesn’t tell us about whether other people did equally well who didn’t get surgery? So it doesn’t really answer the question very well. So there have been three RCTs so far on this question, and one is currently ongoing. Two of them so far have not supported doing this. One showed some advantage, but they all used different regimens for intraperitoneal chemotherapy, and we still don’t actually have an randomized controlled trial that’s completely validated, which chemo works, even in people that already have peritoneal meds. So this is a difficult question to answer. There’s a lot of people who are still working very hard to answer it.

Dr. Godfrey 24:24
As many of you have experienced, and all of you can certainly imagine, if you haven’t, there’s a ton of preparation that goes into a big surgery like this. Many of you have probably gone through this process of having all these tests and imaging to assess you to prepare. Almost everyone gets chemotherapy before they even go to the operating room. There’s questions of nutrition and getting your nutrition status improved. There’s physical therapy to prepare for the demands. There’s also a lot of financial and spiritual and emotional preparation, because it’s obviously very demanding to do this, and then have to think about the recovery process. And then when it comes to recovering, most of the same things still have to happen on the other side. But there are also issues of potentially having complications. There’s also social recovery and spiritual and emotional recovery, of coming back from this major event. Some of the complications that people have to think about, and people are typically warned about, before deciding whether to have cytoreduction, are short term complications, like we call serious morbidity. The rate of that is about 13% we think for the surgery. When we say serious morbidity, we talk about things like cardiac arrests, wound infections, wound dehiscence, needing to be on a ventilator, getting a pneumonia, getting other kinds of infections, having any kidney complications. And that doesn’t count all of the smaller but very significant things that can impact your care experience, like being stuck in the hospital an extra day or two because of delayed bowel function, or, having what we call an ileus

Dr. Godfrey 26:15
Longer term, we’ve started to study what the long term experience is after site a reduction, and Everybody tells us that the first three to six months, at least, there’s GI dysregulation. There’s a lot of working through post op pain. Everyone has poor energy. It’s like running a million marathons and then having to recover from that. Now many people do get back to work, but some people can’t, because it takes that much out of you. Most people do tell us that if as they’re getting better, if they’re still getting better around six to 12 months post op, they do start to feel normal again. But that isn’t true of everyone, but most people say the two things that still bother them are fatigue and pain. Limitations of these kinds of studies are that people have been very generous with their time to tell us how they’re doing, but people who do worse and feel poorly sometimes aren’t able to tell us how they’re feeling, and so that makes it difficult to tell what happens to folks who’ve had that happen to them. Cancer recurrence and progression after cytoreduction does usually happen eventually, but not always, and it differs by how complete the original surgery is. So median survival data that’s out in the literature says about 40 to 50 months if we can get all of the the tumor out. So that is an improvement over not doing it, but it carries with it, obviously all of these substantial things to think about and risks.

Dr. Godfrey 27:45
When we talk about having a conversation with somebody on the doctor’s side about, should I tell this person that we could do cytoreduction, what are we thinking about? We’re thinking about when it’s possible. So that means somebody with PSM can have surgery that their overall health is good enough, their heart would be able to stand the anesthesia, other things like that. But we’re also thinking, could we get a substantial amount of the cancer out that would be helpful? Can we get out enough that it would have what we call a cancer advantage, or could we at least give somebody some relief from symptoms. When we’re talking about getting a cancer advantage, the guidelines that the consortium I’m part of, concluded was that a PCI, which is the index of how much cancer and where in the abdomen it is, needs to range from 19 to 25 which is a moderately high number. If it’s very, very high, that means there’s too much to safely remove. And our goal is achieving what we call CC-0 or CC-1 status. And that just tells that it’s just a measure of how big the tumors that are left behind can be. CC-0 means there’s nothing left that we can see. CC-1 means 2.5 millimeters or less. The reason this matters 2.5 millimeter tumor, we believe, is small enough for chemo to get into them when we perform intraperitoneal chemo. Unfortunately, sometimes we don’t know if it’s possible until we’re in the operating room. And one of the parts of decision making that I talk to a lot about people who are part of DECISIVE is that it really affects how you feel about your decision when you ultimately can’t do the thing you set out to do. So this is a situation that that we hope to improve through other avenues of research, but that I also want to help better explore and prepare people for as a part of this work.

Dr. Godfrey 29:46
And just to summarize, we also think not just as it possible, but is it going to be helpful for you? We think about is the cancer slow growing enough, indolent enough that surgery will help? But it’s not so slow growing that there isn’t a reason to do surgery, if that makes sense. And we want to make sure it’s compatible with people’s holistic life goals, because cancer is a chronic disease and it takes time to treat and think about, and it’s a long journey to navigate together. For people who can’t or don’t want to have cytoreductive surgery, we’re thinking a lot about the best ways to move forward without surgery. Most research right now is focused on targeted systemic regimens, things like immunotherapy or biologics. There are some surgical strategies that we study, like iterative HIPEC and serial CRS, where we do things in stages, give treatment time to work, and then go from there. But none of this is ready for the general public. It’s all still under studies, and we don’t have a good idea yet of how it could be helpful and and how helpful. All of this is to say, at some point, we as doctors and people who take care of people with PSM have to decide whether surgery is something that we think is the right choice, and then you have to decide whether you’re ready to say yes to it or if it’s not the right choice for you. And the stress of navigating that decision, called decisional conflict, is one of the things I really want to improve. You can have that stress, even if you feel like your options are very clear. For some people, your doctor may say yes, every factor leads to saying, yes, let’s do surgery. We think we can get it all. If we don’t, it’s going to come back and you’re healthy, it’s going to we think you’ll do fine, but that’s still a big decision to make. You know, it doesn’t matter how simple it is, it still is a lot to process. And for some people, there may also not be a clear answer as to which choice really fits your goals. Not only is the decision in front of you, one that we’re that has potentially been in front of you, been one that requires a lot of thought, weighing all your options, but PSM and cancer specifically, that make it even more difficult than just a straightforward surgery or no surgery type of question.

Dr. Godfrey 32:20
We know that stress and fatigue get in the way of patients and their family’s ability to feel confident about what the next step is. It makes it hard to navigate your options when everything feels very high stakes as it is. And there are a lot of other considerations to think about, like all the intensive preparation and then planning for things that will be important once you’re on the other side of it, which is something that historically, doctors aren’t very good at talking about. We’re good at talking about the how do we get you through the moment part, and less good at the long term part. And what I’ve heard personally from people who have been part of DECISIVE and who I’ve seen in clinic taking care of and from the people that love them, is that even when the outcome is good, even when people feel like they made the right choice, there’s a lot of questions and regrets they had about the process itself. They wished it would have gone differently. They wish different conversations that happened. A lot of people say, Well, I didn’t know I had any options, or I didn’t feel like I had any options which are different but important, complimentary concerns. Some people felt very pressured for time, and they didn’t feel like they had the information they wanted, or they were emotionally prepared yet, but they had to jump in there and make a decision. Many people also said, Well, I had no idea this was what this was going to be like. And a lot of people wanted to talk about things like fertility concerns, and that wasn’t something their team could do. Follow up care, long term changes in their health, all of these are things that people report have not really been adequately described.

Dr. Godfrey 34:00
Clearly we as surgical oncology researchers and practitioners, and more broadly, the people all over the country who take care of cancer are not always giving our patients and the people who love them the right kinds of support for making decisions about this process. So as a physician in training who’s worked under and learned from an expert like Dr. Turaga, I’ve gotten to see what some of the best, most expert counseling and systems and big hospitals like Yale have to support patients. But the interactions that I’ve had with people through these talks, through DECISIVE, through national meetings, have really highlighted that a lot of the time these resources are not available or they’re hard to find. The public knows very little about PSM. Support and patient advocacy groups are often the only vehicle people have to talk to other people who have had this. They are some of the best sources for reliable information and for peer support. And while some programs like mine, some institutions that are actually providing the care do provide education, it’s often really only written packets. And the science that we have about how people make decisions, key media, information, interactive formats, plus often written things that people can refer to later, are the most helpful tools. So we take this need and we look at what people in other fields of surgery are doing. People in really common cancers, like early colon cancer, transplant surgery, endocrine surgery, even bariatric and preventive surgeries have tools called decision aids to help them, and there’s a lot of knowledge about how people make decisions.

Dr. Godfrey 35:50
So like I was describing, we know that there’s a difference between making the right decision and feeling good about the decision you made. People with cancer tell us that overall, compared to people without cancer, there’s more dissatisfaction and regret about their surgeries. Surgeries that are more complicated, people often report being more likely to regret the process by which they decided because they didn’t feel as prepared for what the outcome was going to be, because the complexity means so many different things can happen. It’s impossible to anticipate them all. Side effects that interfere with daily life also have been shown to contribute to regret not feeling good about making the decision. Even patients with common cancers like thyroid cancer say that the information that they’re given about their cancer and the next steps often is not delivered in a way that they can retain or understand. Doctors are often not great at turning things into digestible bits, but you also have so many things running through your head with a new diagnosis that providing you with something you can refer to, providing you with something that you can come back to when you need it is absolutely key.

Dr. Godfrey 37:04
And there’s also a substantial body of evidence that physical, mental and emotional symptoms of cancer and all of its treatment, like chemo, make it literally difficult for the brain to process information. So what is the solution to all of these problems? There’s symptoms that affect your ability to think through what’s happening next and remember things. You’re very busy. There’s a lot to think about, a lot of treatment burden and load and effort. People don’t always get the information they need, and doctors aren’t always very good at helping you explore what your values and priorities are for care. So the solution to this in other fields has been shown to be something called decision aids. What is a decision aid? Well, it’s something that helps make your choices clear. It gives you the data that matters the most for you, and then it gives you the data and the choices in context of what values they fit best with for you. This can be an app, it can be a pamphlet, it can be an interactive flow chart or algorithm. But regardless when they are provided to people, we’ve shown that they increase knowledge about treatment options and risk. They decrease conflict about the decision. They increase satisfaction and well being about it, they help make decision making feel more shared and less one sided. And they increase what patients tell us are the number of their decisions that match the values and things they hold dear. Couple of examples just to flip through. One is by my mentor, Dr Greenup, when she was a professor at Duke, she did this. She created a decision tool for her breast cancer surgery patients, which is obviously a very different group, but the strategies and the programs and the educational principles are similar. That started with an education module that people could refer to refresh their mind about information they needed to make their decision. And then it guided an individual through choosing between pairs of possible outcomes. So it said, if you have this surgery, this is a possible outcome. If you have this surgery, this is a possible outcome. And it allowed people to choose which outcome they found more tolerable. So that after a series of these comparisons, at the end, an algorithm computed what people’s latent priorities are and helped them visualize, sort of what that looked like for them, and give them something they could talk to their doctor about. The limitation is, this is kind of burdensome. This is a lot of button clicking, a lot of thinking. It makes people do more work when they’re already at a very stressful time, for all the reasons I already talked about.

Dr. Godfrey 39:48
This is a more descriptive decision aid, a more informational one. It’s about LVADs, which are circulatory devices that people who need heart transplants get. It has mostly educational information, but it also has a lot of stories. It has discussion guides, and it has information, not just for the person making the decision, but also the caregivers in their life. So this works to present numbers in a visually relevant way, things that people can process better. Doctors are terrible at understanding percentages. Everyone is terrible. We found through education studies at understanding percentages, but what helps is seeing a number of people out of a number of people. So that’s one of the strategies that this tool used. So what do we need to make a decision aid that works, available for people with PSM. Well, one aspect is determining which of those decision aid strategies is best for people, and it also involves learning from people with PSM about what information they want included.

Dr. Godfrey 40:57
Decision making is a very human experience, as a doctor, guiding it and being a part of it is part of the art of medicine, but the science of medicine and decisions can also help us do a better job. So one of the things that we have to dial back and do to make these decision aids is think about what we don’t know. One of the things we don’t know enough about is patient perspectives for peritoneal cancer and patient and caregiver decision needs and satisfaction. So Dr Alyssa Greenbaum, who’s somebody I’ve collaborated with in the past, has studied this, starting with appendix cancer, and has found that 15% of participants in the group that she worked with expressed regret about their decision. The more difficult post operative experiences typically went with higher regret. So people who had more surgeries, whose cancer came back early, those are reasons that people regretted it, but also just having experiences that they hadn’t been warned about in advance. And next steps are looking at this in colorectal cancer, which is why I’m here with you today. Even with that study, which is a great start, we still don’t know what the actual needs people say come with their decision, and nobody else has yet tried to make a decision aid for this question. So that’s what I’m doing here with DECISIVE.

Dr. Godfrey 42:22
This is anonymous survey. It’s for anybody who’s ever thought about having side reductive surgery. So if you ever spoke with a doctor about it, if anyone that you have cared for has spoken to a doctor about it, whether or not you’ve had it, we still want to hear what your experience was, because that helps us understand if you got what you needed, and if you didn’t, how can we fix that? It has 10 pages, nine if, if you’re not a caregiver. So that that 10th page is for caregivers. The first two are basic demographic and medical information, tells you about the person responding and a little bit about their cancer. The next part is accessing evaluation. Some people have a very hard time finding a surgeon to talk to about cytoreductive surgery or to give them the information they need, and thus seeks to explore that. The next two questions are really get at the meat of the decision making. It talks about how was that initial decision made, and what priorities and obstacles did you have? There’s several free response questions for those that have the time and inclination to do so. That gives us an opportunity to hear your story, your in depth opinion about what we could do to make decision making better in PSM. The next two pages just are questions about how that treatment played out for you, whatever you chose, whether it was CRS or not, or whether your loved one chose it or not. This helps us understand how the experience of what happened after the decision affected your experience of the decision. Then the next two pages are about quality of life now or towards the end of the person with cancer’s life, if they’ve passed away, and for caregivers, also the impact of their experiences and how they are still feeling about them. And then finally, we end with some simple questions about satisfaction with the decision. All of the parts before that, tell us about the details and characterize that decision in the end as an opportunity to say yes or no how you felt about it, and afterwards, there’s a place to rate the quality of survey. You can volunteer to join us or help us with future work or enter it’s actually not a prize raffle. It’ll be a gift card for the first 50 people to respond, just to thank you for your time, because it does take time to contribute to things like this, but we so appreciate the stories that you have to share, because they are how we can make it easier for the next person. Once we do this, we’re going to take all these responses. I’m going to be analyzing them for the next several weeks to months, and use that to develop a tool in collaboration with patient advocates that I already work with, and also those of you who want to be involved, to do all of those things that we wanted to do with a decision aid, elicit key values, give people the information that’s relevant to them, and then bring that back to how to make the best decision. And then we’ll start to test that tool with patients and families. So we need you to take the survey, invite others, tell us if you would be interested in working with us, and later, eventually, tell us what you think of our tool. So here is the QR code. I’ll share the link in the chat in just a moment, but I want to give you time if you would like to use the QR code.

Speaker 1 45:49
I’m going to close this survey for you guys probably around the 31st of December. So you have about six weeks. You can save the survey, you can come back to it with a code at any time. There’s instructions on all of how to do that, if you if you are so inclined to join us, which we would appreciate. But thank you all so much for listening today. I know Megan has probably got some questions for me from the chat.

Meagen Lockhart 46:15
You do have a couple of questions. And thank you so much for all of the information you shared. As a stage IV patient myself, that’s over five and a half years into my own diagnosis, you would think the questions relating to making surgical decisions get easier, but I found that they’re just as hard as the day one. So I’m so glad that there’s going to be more information developed for patients to assist them in making those those choices. We do have two questions both, from Jim, so his first is, it seems that patients have to push pretty hard to get laparoscopic look to see their level of peritoneal metastases. Is there any work done to make this more of a standard of care or to make this an easier choice, to get patients to understand their burden of disease?

Speaker 1 47:18
Yeah, solet me go back to the the guideline slide. So for for some people, even if you have a high risk tumor, other characteristics make it less likely that it’s going to become a peritoneal metastasis. So we think we we don’t necessarily recommend that everybody get surgery just to check because that has risks too, anesthesia is still a big deal. But what we do tell people is that there are times, several inflection points in care, when we should think about doing diagnostic laparoscopy. This particular guideline that I shared is for people who have peritoneal mets when we first diagnose them, the synchronous group. So it’s less clear, but one of the things that we also did as part of the consortium was talk about how to surveil people and think about whether they need a diagnostic laparoscopy or not. Sometimes, even though it’s hard to see on imaging, we see indications on imaging. Sometimes we see it in tumor markers. Often symptoms do clue us in. But on this slide, there’s several places where we say, Okay, if you think somebody might have peritoneal mets, you know, do a diagnostic laparoscopy, see where we are. And then here it says systemic therapy. And then, okay, do your restaging. And then, okay, do a diagnostic laparoscopy. So our consortium was very, very reliant on saying, you should be thinking about doing diagnostic laparoscopy if this is something that’s safe to do and and you’re suspecting peritoneal mets, that that’s something we should do. So, so, yes, there is a push to make it more systematic. We’re still gathering data on the exact criteria, and that’s something that I think we’ll get better at as these guidelines start to be used widely, because more people will be providing the same type of care and taking the same steps.

Meagan Lockhart 49:34
Wonderful. Thank you, and I know Dr Turaga has a number of fans in COLONTOWN as well, and also from Jim, an earlier slide mentioned a surgical trial in Italy. Are there any surgical trials that we should be watching that are going on in the US? And then, are referrals ever made for patients to get into trials in other countries where these surgeries are being done?

Speaker 1 50:03
I so there’s always trials going on. Most of the ones I’m aware of right now are not surgical, they’re medical. For this particular situation, there are places that are currently doing PIPAC trials in the United States, and there, I know I do happen to know a little bit more about the clinical trial landscape in appendix, because that’s my specific area of expertise. But I partner with our colon expert. So the only one that comes to mind immediately is PIPAC, and then iterative PIPAC. I mentioned some places are studying that, and some places are studying serial site reduction. But I don’t know if the serial site reduction is active, but iterative HIPEC is something that’s being done now. You can always go to the National Clinical Trials website and search for peritoneal and that will pull up any actively registered trials in both the US and other places. I don’t have a lot of information for you about how to get involved in a trial in another country. There’s often some limitations that have to do with how their health care system has completely different sort of intakes and enrollment and and financial situations. So I don’t know much about that, but many of them are still registered in the United States National Clinical Trial database. So if a person saw something that they thought applied to them, there’s usually an email that they could contact if they wanted to engage. One of the things that I briefly mentioned that we care a lot about as a group, is centralizing clinical trials. Right now, most of that is happening through institutions that are partnered with each other, but what we’re trying to do is over the course of the next couple of years, develop a central registry where people who have PSM can sign up and say, I want to be monitored by this group in this collective pool where all the trials are happening together. So more on that later, but we’re still in very early stages of seeing how that would how that would look

Meagan Lockhart 52:19
wonderful. Thank you so much. And I do have a question of my own. Is the survey open to members of the US or any patient worldwide?

Speaker 1 52:29
It’s the US only. Unfortunately, the Yale information security people told me no, I couldn’t give it to people in Canada, and I had somebody ask too, but potentially later, if I’m doing interviews or something like that that are more personal, or having people be in focus groups to help me tweak that tool, that’s something that the rules are less strict on. So I’d love involvement from anybody. But unfortunately, the survey is US only.

Meagan Lockhart 52:54
No worries just I’ll make note of that as we share, although the vast majority of our yes members are American. No worries.

Dr. Godfrey 53:02
That actually came up with somebody a couple weeks ago, and I felt really bad because they really were excited to contribute so.

Meagan Lockhart 53:12
Well, we’ll be happy to share the Canadian perspective when the time comes, for sure. But in the meantime, I know a number of our members are looking forward to this, and I really hope that something comes from it that will really help patients make these important decisions and feel a bit more confident in their choices.

Dr. Godfrey 53:30
Yes,

Meagan Lockhart 53:35
Thank you so much

Meagan Lockhart 53:32
We all hope for I just shared the survey link too, so I know it’ll go out other places, but if anybody’s still in the chat, they can grab it. Wonderful. Another question people ask, can my caregiver or my friend or whoever take it, even though I already took the survey? Yes, please. We love that. We love everyone’s perspective. That’s one of the main questions that comes up. So yeah,

Speaker 2 53:58
Wonderful. Thankyou so much for sharing your time with us this evening.

Dr. Godfrey 54:01
Well, thank you guys for for hanging out with me while I talked for an hour.

Dr. Godfrey 54:06
Happy to have you