Sarah Psutka: Thank you, Ashish. So good to be here.
Ashish Kamat: So Sarah, really, you need no introduction. I mean, you have been doing bladder cancer for so long, and sometimes I joke that you should also not be doing kidney, but of course you need to be doing that. But across the spectrum of cancer care and patients and advocacy, you've really been at the forefront of having an interest in developing patient-reported outcome tools. And at the recently concluded International Bladder Cancer Group Retreat, Task Force Meeting, whatever you want to call it, you were, I guess, volunteered by me to lead the patient-centric IBCG patient-reported outcomes tool. So thank you for accepting that task, and looking forward to what you have to say to share with our audience as to what your thought process and the process has been so far.
Sarah Psutka: Well, thanks, Ashish. And I think this was a tremendous opportunity that you kind of gently handed me, but I will say I'm really grateful for it. So this is just a preamble before we jump into these slides. I would say patient-reported outcomes are so important. And my interest, a lot of the interest in the trials that I've been working on and the sort of supportive oncology focus that I've had recently has really been towards doing a better job of having us as physicians understand the human experience of having cancer, the patient experience of the lived, day-to-day life of a person who's a survivor with cancer, either going through active treatment or in the survivorship period. And this is an opportunity to really force myself to think much more deeply about this. And so, I appreciate that. So these are a summary of the slides and really the discussion that we led, because I would say that what happened at IBCG this year was really an introduction to what is going to be a year-long, years-long, but year-long effort here as we start to think more deeply about how we can take the PROs we have and really make them do their job better, work better.
So I had the opportunity to work with a really tremendous team that was co-led with Kelly Bree from MD Anderson and then Dr. Kamal Pohar, Dr. Ben Pradere and Dr. Shilpa Gupta kind of joined and rounded out this wonderful team that was really tasked with trying to think about how we can use PROs in bladder cancer care to better capture the patient experience and really moving towards a patient-centric patient-reported outcome tool. So our task is to develop and validate a comprehensive patient-reported outcome tool that could really be used across clinical scenarios from the non-muscle invasive space, to the muscle-invasive space, to the advanced disease space, and hopefully something that will have longevity, that will be relevant now in contemporary practice, but will also have relevance in future scenarios, and importantly that will have relevance not only in clinical practice, but also in clinical trials so it could be something that we could really use across the management paradigms of bladder cancer.
And the goal is to have a tool that efficiently captures health-related quality of life and general health statuses that gets into cancer-specific and bladder-specific health-related quality of life, but also captures those nuanced patient-centric outcomes that are oftentimes not captured by conventional tools. But the other piece of all of this is it needs to be parsimonious. It needs to be nimble. It needs to be modular. We need to be able to adapt it to disease stage. And then again, capture all of the sort of, I would say oftentimes not necessarily easily captured nuances of what is the lived experience of bladder cancer treatment and survivorship. And so, this is a sort of a highlight. Again, this is really what we're trying to drill down on. So we want to include a tool here. We want to develop and prioritize the development of a tool that includes questions that capture all areas that are prioritized by patients. We really want to move towards understanding what are the aspects of the lived experience of bladder cancer that are relevant in day-to-day living? And we need to hear that from patients.
This has to be something that is translatable into multiple languages so that it can be used equitably and sort of democratized. And ideally, especially given that the IBCG is such an international organization, we'd like it to be something that can be internationally relevant. It needs to be freely available and accessible to researchers and providers so that it will be used widely. And then, it has to, again, be both relevant, not only to patients, but also caregivers and then of course to providers. And if we look at the number of PRO tools that we currently have at our disposal, so there's generic patient-reported outcome tools, and then there are a number of very good bladder cancer-specific tools. But I would say that there's redundancy between those tools when they're used together. So you end up having patients potentially subjected to survey fatigue. There's variable inclusion of sex and/or gender-specific questions which can introduce complexity, and I would say can potentially alienate some patients. There's variability across tools in terms of the recall periods and the questionnaire length.
There's lack of rational design to minimize survey fatigue, which is very important. So we need to, as we get more comfortable with, for example, AI technology, think about how we can create surveys that really respond to the patients' responses so that we're not asking questions that don't need to be asked and minimize the amount of time patients are filling out these surveys. We definitely need to make sure that we are capturing all of the salient domains for patients. And then, of course, these tools need to be relevant in the setting of not only contemporary therapeutic strategies, but those novel therapeutic strategies that are going to be developing in the future. And I would say I've been inspired by the work that Cris Bergerot, who is a colleague and really, truly an expert in this field has done. And she's led a lot of work trying to tackle a similar problem in this sphere in kidney cancer. And what her work has demonstrated is I think that the major punchline of some of her recent publications is that many of the PROs we have don't actually capture or evaluate questions that are truly salient to patients if you ask them. So they're asking about symptoms that have a high degree of variability in terms of the relevance. And you can see here, just if we look at one of the classic kidney cancer PROs, she asked patients whether or not the questions that they were being asked were relevant, and there was a very high degree of reportedness of non-relevance.
And so, we have started to put our heads together to really brainstorm some potential domains that need to be better characterized among those patients who are dealing with bladder cancer, either active treatment or survivorship. And those span domains that are not only the bladder function-specific domains and sexual function domains and physical and health-related quality of life, physical function, but they need to ask patients more discreetly about financial toxicity. And IBCG is leading the charge in this trying to get at the development of PROs that capture toxicity of treatment, especially novel agents and new drugs that are leveraging different mechanisms of action that are going to have different types of toxicities than what we've seen with conventional treatments. And then, we need to get into emotional symptoms, gender-specific questions. I think there's a lot that I've learned from my work in the geriatric space in terms of functional ability and independence, which we're just not capturing in conventional tools. And then obviously, understanding the impact on the family and caretakers, the implications of all of this for treatment burden and really the work of being a patient. And then, I love the idea of some of these novel treatment utilities that are increasingly being incorporated in trials, which is getting at a composite endpoint that not only looks at the efficacy of a novel treatment, but also the patient's assessment of the worthiness of that treatment, and putting that together to try to understand the actual utility of that treatment.
So we have started to lay out the task force work plan and try to set our steps in front of us. I'm currently with a couple of my trainees leading a systematic review that is really trying to understand what PROs we have across the bladder cancer domain, but we're also scoping PROs that may be in adjacent fields that will have high degrees of relevance to our patients. And then, we're going to specifically start to look at taking those tools, learning from them and trying to develop something that will be nimble, parsimonious, but highly relevant to our patients. And then, the next steps will be really to beta test that and lay it before patients, advocates and caregivers to understand not only the relevance of what we think might be helpful, but really get their feedback on what we're missing, and then of course, test and validate. So I'm excited to take this work on. I'll stop sharing here and excited for what we're going to learn in the process, but also I'm very hopeful that we'll emerge with something that will have a high degree of relevance for our patients and their caregivers that will do a better job of characterizing the experience of having bladder cancer.
Ashish Kamat: Thanks so much, Sarah. And I think you summarized that really well with your closing statement, right? Because we want to develop a tool that is relevant, translatable across different languages, simple so that it's not an added burden for our patients who are already going through a cancer diagnosis and participating in a clinical trial. And then, we throw another survey at them to get patient-reported outcomes, which is very, very important, but we don't want to have survey fatigue. And that's why I think a tool like this, which is ultimately going to be open access available to anybody that wants to use it, coming from an organization where pretty much everybody is there together because we truly care about improving the lives of our patients, I think is really, really important.
So again, thank you for taking this on. I do want to ask you a couple questions because I've heard these from patients, and I was just approached actually this week by a patient when I was at EMUC and then last week by one of my own patients saying, "Hey, I would like to take part in this." And of course, then we're talking to patients and talking to them, and obviously I can't mention names, but you know some of them because they've been at these forums and voiced their experience and their journey. And one of the questions the patient said is, "Why are you actually not just asking patients to list questions? Take a hundred patients, have them list questions, and then use AI to see if there's overlap, and then just create a new PRO." So in some ways, I think that reflects a little bit of what you and I talked about, not necessarily trying to collate everything that's been out there, but to come up with something novel. Thoughts?
Sarah Psutka: I think that's a... Well, your patients are asking the right questions, because at the end of the day, what we have, most of the PROs that we have, were developed by doctors for patients, right? They were physicians looking at what we know the side effects of these therapies should be. So we're trying to ask all the questions and develop with the best intent to really capture everything that we thought was important. The problem is, the patients need to tell us what's important. So that's actually... That may be an interesting experiment to run and to see what kind of overlap we get. Now, I don't pretend to be an expert in developing PROs.
In fact, you're very kind in your introduction, but this is something that I've thought a lot about, but people like Dr. Bergerot are true methodologic experts in developing and validating these tools. And there's a whole science, in terms of how these tools are carefully developed, carefully vetted, every word is scrutinized, and then the validation to make sure that you're actually getting at the domain that you think that you're getting at. So I think that this is actually a complex science. We are going to try to build something that's going to be nimble that we're going to put in front of patients and get their feedback from. But I think that actually one of the real benefits of doing this through the IBCG is our very detailed and very deep partnerships with a number of different advocacy organizations where we can actually have patients at the table throughout this whole process.
Ashish Kamat: Yeah, I think that's absolutely-
Sarah Psutka: They're going to have hands on this whole process and they're going to touch every point of it, because at the end of the day, it's not what I think is relevant. It's what the patients think is relevant.
Ashish Kamat: Right. And I think that is essentially the essence of the issue, right? Because all these tools that we, and I'm guilty of this, too, we jot down what we think is important because we really care, but it's our opinion, right? And then, we then try to take it to patients and say, "Hey, what do you think about this?" And we take it to their caregivers and say, "What do you think about this?" Instead of that, why not just redo the whole process and start with them and then have the physician say, "Hey, what do you think about this?" Because that way we can then provide our flavor and our scientific rigor, and Cristine's great, and get people involved in this, but have it come from the patient. So I think what you and the team have planned is really excellent. You always deliver. That's not a threat. It's me just telling you that I know you will deliver. And once again, thank you for taking that on and thank you for taking your time and sharing it with us here on UroToday. Thank you for the opportunity.
Sarah Psutka: Well, thank you. I think that one thing that I love about this challenge, and I will call it a challenge, is it's what I've been thinking about. So one of the biggest projects that I've been embroiled in for the last two years has been what we're calling the University of Washington Bounce Back Study. This is a study that we started funded by the NIA a couple of years ago that is tracking repeated measures over time of quality of life. And I incorporated a whole bunch of geriatric PROs, because I was trying to understand what recovery really looks like after cystectomy from the patient perspective so that when patients say, "When can I go grocery shopping again? When am I going to be able to go visit my kids in Arizona? When can I go to Paris with my wife for our anniversary?" and we're in the context of an upcoming radical cystectomy.
And as a doctor, the answer is, "I don't know. I don't have a prediction tool to tell you that. I can tell you the likelihood of the disease coming back based on the pathology, but I can't tell you when you're going to get back to life." And you and I both know how variable these recovery trajectories are. So I've learned a lot in my initial analysis of the first 82 patients that we have in this prospective registry, which we're now opening at a number of different institutions, and it's made me think much more deeply about how imperfect our tools for collecting and characterizing that experience really are. And I think we have the opportunity to do something here that is really novel. And I think we have the opportunity to do something here that has potential for a substantial impact. So I'm excited by the challenge. Our team is going to try to be really thoughtful in how we tackle it, and I am super excited that IBCG is taking this forward.
Ashish Kamat: Absolutely. And I know you will.