Prehab for Bladder Cancer Patients Explained

April 8, 2025

Transcript

Voice over:

This is Bladder Cancer Matters, the podcast for bladder cancer patients, caregivers, advocates, and medical and research professionals. It’s brought to you by the Bladder Cancer Advocacy Network, otherwise known as BCAN. BCAN works to increase public awareness about bladder cancer, advances bladder cancer research, and provides educational and support services for bladder cancer patients and their loved ones. To learn more, please visit BCAN.org.

Rick Bangs:

Hi, I am Rick Bangs, the host of Bladder Cancer Matters, a podcast for, by, and about the bladder cancer community. I am also a survivor of muscle invasive bladder cancer, the proud owner of a 2006 model year neobladder, and a patient advocate supporting cancer research at the Bladder Cancer Advocacy Network, or as many call it, BCAN, producers of this podcast.

I’m pleased to welcome today’s guest, Dr. Sarah Psutka, back for her second podcast. Dr. Psutka is a urologic oncologist, specializing in bladder and other genitourinary cancers at the Fred Hutchinson Cancer Center in Seattle. She’s also associate professor of urology at the University of Washington School of Medicine. Dr. Psutka is also one of two recipients of BCAN’s first ever Translational Clinical Trial Award, the TCTA, for her Get Moving clinical trial. This trial will enroll patients who have muscle invasive bladder cancer and are undergoing chemotherapy, followed by radical cystectomy. Her project aims to study how personalized exercise intervention and pragmatic prehabilitation can improve patient outcomes and health-related quality of life, and that’s going to be the focus of our podcast today. Dr. Psutka, thanks for joining our podcast, and again, congratulations on your BCAN TCTA award.

Dr. Sarah Psutka:

Thank you so much, Rick. I’m thrilled to be back and to have the opportunity to speak with you again.

Rick Bangs:

Yeah, and we’re excited to hear about this trial. So in 2023, you got this first ever Translational Clinical Trial Award, and the trial name again is Get Moving. So, what does the award actually entail?

Dr. Sarah Psutka:

Well, this was really an unbelievable opportunity for our research team, and I don’t think I can put into words how grateful we are to BCAN for their support of this idea.

So, the Translational Clinical Trial Award was released, the RFA, which is sort of the advertisement for it, was released in 2022. And what it really was looking, it was a $3 million grant that was supplied by a very generous donor with the objective of supporting a clinical trial that would be somehow transformational. And in my lab, we study ways to accelerate recovery, and we study ways that we can reduce the burden of treatment for cancers of the genitourinary tract. And I focus specifically, my practice is specifically focused on kidney, bladder and testicular cancer. But we really do think about how we can develop pragmatic interventions that will help people basically tolerate treatment better, get better faster, and hopefully we can improve quality of life across survivorship. And I’ve spent a lot of time thinking about how nutrition and exercise and other supportive measures can really help us deliver better cancer care.

So, this was an opportunity that our team jumped at because it’s actually really hard to fund the kind of work that we do because it doesn’t fit neatly into a classic research process. We’re not studying a new drug specifically, we’re not studying maybe molecular pathways, although there are a lot of translational correlates that we measure that are associated with the interventions we look at. But we’re really looking at some things that are maybe a little bit more common sense, but definitely sort of off the beaten path. And as you and I were sort of discussing as we were getting ready for this podcast, one thing that’s been really needed, is there’s been a lot of traction gained around these kind of supportive oncology interventions that previously had not really had a true, I guess, home.

But anyhow, this trial or this grant has just been an incredible opportunity. So we put in an application and we were actually, we’re one of two awardees, and so the award was split between us and the lab of Dr. Amir Horowitz, who’s a cancer immunologist at Mount Sinai at the Icahn School of Medicine. And Dr. Horowitz and Dr. Galsky and Dr. Sfakianos, his two co-principal investigators, are actually looking at a proof of concept for a novel immunotherapy combination of two drugs. So, they received a part of the grant award and then we received a part of the grant award, with the objective of supporting the trial that we proposed, which is this Get Moving trial, which we’re going to chat a little bit more about.

But it’s just been an incredible opportunity, so it’s a three-year grant. So basically, a very tight timeline for running a clinical trial that is very generously supported by BCAN and their donors, with the objective of bringing a new domain of science. Really advancing this new domain of science and figuring out if we can put some hard data behind some of the hypotheses that we all have been working on for the last couple of years.

Rick Bangs:

Okay. Let’s get into some of those hypotheses. So the name for the trial is Get Moving, and I think it’s a pretty good description of the trial. So, tell us what the trial’s about.

Dr. Sarah Psutka:

Yeah, so basically we call it the Get Moving Trial, and I think the objective here is to understand if a personalized exercise prescription can be, one, feasibly delivered through a, we’re using a mobile health application that was developed by engineers at the University of Washington. So, we have an app that is called Exercise RX. Exercise RX was previously developed to help deliver exercise prescriptions and track exercise in different patient populations. So it’s being used in some pediatric populations, it’s been tested in some trauma populations. But my collaborator, Dr. Cindy Lin, who’s a sports medicine and physical medicine rehab physician, she and her engineering team developed this app. And it’s a funny story of how it’s a very small world, but Cindy and I actually went to medical school together and when I got to U-Dub, we kind of reconnected and realized that we had some really synergistic research interests for a urologist and PM&R doctor.

So, Cindy and I started sort of talking with one of our other collaborators, Dr. Hanna Hunter, who’s the head of cancer rehab at the Fred Hutch Cancer Center, about how we could maybe leverage the incredible methodology that Cindy and her team have developed to start thinking about how we could deliver personalized exercise prescriptions to cancer populations. So, the idea is the trial is a randomized controlled trial. That means that patients, when they consent to participate, they’re randomized using a computer program to one of two arms. And the active intervention arm is an arm where patients not only get a personalized exercise prescription that is geared towards developing core strength and hip girdle strength, and lower extremity strength. We’re trying to build up the kinds of strength that is going to be needed to help patients move around after major abdominal surgery.

And they basically, they’re given these exercises, and I’ll tell you more about those in a moment, but also they get personalized walking step recommendations and it’s all based on, we meet people where they’re at. One of the things about exercise is that obviously it can’t be one-size-fits-all, because we may have patients coming into this study who are actually very active athletes who may go to the gym routinely and exercise and workout, run, lift weights, all those sorts of things. And we may have patients who come in who actually are relatively sedentary, maybe require an assistance device to help them get around and locomote. So we can’t give everybody the same recommendations. We can’t say everybody needs to do these weights or get on the treadmill for this many minutes every single day. That’s just not going to work, it’s not pragmatic. So we actually, the whole trial starts with a personalized assessment of where people are at, and then we build an exercise prescription that’s based on where they’re at and where we kind of want to get them to before surgery.

So trial participants, if you’re in the active arm, then they get these step counts which are delivered through the phone and actually, we also track their step counts through the phone and through a Fitbit that they wear. And then they also get these daily exercise prescriptions and we ask them to do the exercises four times a week. It takes about 20 minutes to do the exercises, they’re meant to be very pragmatic.

But the other exciting thing about the trial is it’s also an active recovery trial. So, once patients then go through their surgery, and these are patients who are going to go through either a radical cystectomy or we actually, and we’ll talk a little bit about some of the ways we’ve changed the trial as we’ve been running it, but we’ve also expanded it to people who are having surgery for upper tract urothelial carcinoma, so who might be having either a distal ureterectomy or a radical nephroureterectomy. After they go through their surgery, we pause the prescriptions for two weeks for recovery and obviously they can be paused for longer if that’s necessary but two weeks is, it seems to be the sweet spot where people are able to recover in the hospital, get home and kind of get back on their feet. And then we restart the prescriptions at a slightly easier set point baseline, and then they continue to get to do the exercises until they hit the three-month mark after surgery.

So the hypothesis we’re testing is, if we give people personalized exercise prescriptions as they lead into a big abdominal surgery for urothelial cancer, cancer of the bladder, cancer of the ureter, cancer of the kidney, and then we give them personalized prescriptions for the three months after surgery, can we actually accelerate the recovery? We’re looking to see whether it does things like if it impacts things like muscle mass, which is measured through CT scans and using a sort of a fairly innovative way that my lab has been working on developing where we use routine scans to measure body composition. We’re looking at physical performance measures. And then we’re also doing, it’s an implementation study. So we’re also looking at how feasible it is to do this, because we’re actually doing all of this virtually.

And then the control arm gets what we use as our standard of care, which is we give every patient the moving through cancer recommendations from the American College of Sports Medicine. And we support them with our standard recommendations but they don’t get these personalized prescriptions. And we can talk more about the specifics, but that’s the basic outline of the trial.

Rick Bangs:

Wow, wow. Okay, so we’re including people who’ve had a kidney removed, ureters removed, and bladder removed, and all those are pretty significant events.

Dr. Sarah Psutka:

Yeah, so this is one of the challenges of running a trial like this. So, this clinical trial was actually directly born out of a think tank that happened at the Bladder Cancer Advocacy Network meeting back in 2022. So we had this meeting that Hanna and I ran, a breakout session that was all about building resilience. And we talked a lot about functional assessments and personal prehab or exercise prescriptions, because this is something that Hanna and I do in clinical practice because we believe in it really strongly for our patients.

So, if I see a patient who I need to put through, bring towards a radical cystectomy and I’m worried about their physical performance because they come in and they have what we call a high burden of frailty, which is vulnerability based on lack of physical strength, maybe they’re malnourished, maybe they’re someone who lives a pretty sedentary lifestyle for one reason or another. And I’m worried that they’re going to have a hard time getting through the operation, I will have Hanna see them and she does these personalized prescriptions, and then we coach the patient as we get ready for surgery, and then we also coach them afterwards. But of course, we’re doing this because we believe in it, there is some data to support it, which we can talk a little bit about, but there hasn’t really been a trial like this really testing the way that we’ve been doing it.

So BCAN, with this Translational Clinical Trial Award, gave us the opportunity to apply for funding to really test this in a really controlled situation to see if this method, to really start to put some hard numbers on how this method changes things for patients. And so, the one thing we learned though is that running a clinical trial like this in a pretty short timeline means we need to have very pragmatic inclusion criteria, and we also really wanted to make sure that we were kind of making the trial available to as many patients as we possibly could.

So, we initially started thinking we would offer the trial to patients who were going to get chemotherapy and then were going to have a radical cystectomy for their bladder cancer. We quickly learned that just because of referral pathways in the Pacific Northwest and the way that patients get to us, we were going to miss a lot of patients because, just the way that things work. Patients come to U-Dub and the Fred Hutch sometimes in the middle of treatment getting their chemo, but then they come to us in preparation for surgery, but we were missing the clinical trial entry point. So, we were missing a lot of patients that we would’ve loved to have been able to offer this trial just because of the time point at which we were meeting them. And so we worked with BCAN to expand our eligibility criteria so that we could include patients who were getting any kind of systemic therapy before these surgeries and even those patients who were not, as long as we met them about six weeks before surgery, which is usually when we meet people so that this allows us to be much more inclusive.

And then it also, we expanded the eligibility criteria to really include anyone who had any kind of cancer of the urinary tract, so renal pelvis, ureter, or bladder, because the patients who were getting nephrouredorectomies had a lot of the same risk factors as those patients having their bladders removed. It’s a different surgery, but it’s still a major abdominal operation. The hypothesis is, can we help people who are having a major abdominal surgery for urothelial cancer accelerate their recovery with a personalized exercise prescription? Well, then it makes sense to include that patient population as well.

Rick Bangs:

So, I love the way you’re explaining how as somebody running a clinical trial, like you, is adapting to the information they’re getting and trying to make it more practical and more relevant. So, I think that’s a good learning for our listeners. And I also liked how the genesis for this idea was it was born out of a think tank. So I mean, that’s what the whole purpose of the think tank is, right?

Dr. Sarah Psutka:

Well, it was really remarkable because Hanna and I were doing this breakout session and we were talking about the things that we do and the participants in our breakout session, they literally, there was just this resounding cry like, why didn’t we know about this? Why isn’t this available? Where can we get this? And then we realized that there are centers that do this across the United States, and actually there’s a lot of folks in Europe who are doing this, but it is something that in 2022, it really wasn’t common to discuss it. And I would say that the research on it was a little bit niche, it wasn’t something that was being done widely. So, we were trying to think about how we could meet the needs of our patients and our patient advocates and our caregivers.

The other thing that we learned in doing this, so I had been working with a couple of members of my research team just trying to understand this literature better ourselves because it’s something that, like I said, I believe in very strongly and I’ve directly seen the benefits of in my patients. So the trick is of course in science, you’ve got to put the numbers on it, you’ve got to get the data. Otherwise, it doesn’t matter if you don’t have the data because again, we say science does it. Science isn’t what we believe, science is what we know. So who we needed the data. And so the other thing we were working on though was trying to understand what data was out there.

And so, one of my, who was a medical student at the time who I was working with from Harvard, Logan Briggs, who’s now a resident at Mayo Arizona, he and I wrote a review article a couple years ago where we looked at the state of the prehab literature. And there had been some really neat trials that had been done in this space but interestingly, a lot of them had not quite hit the mark and they’d either really struggled with a cruel, which we certainly learned many of those lessons upon opening this trial, and it’s been a real learning experience for us.

And running these trials are an exercise in being nimble and an exercise in being responsive to patient concerns because these people are going through a lot in preparing for a radical cystectomy or a nephroureterectomy, going through potential systemic therapy and recovery. Asking patients to then jump into a trial like this, we’ve got to meet them where they’re at and make it easy, otherwise it’s never going to work. And that’s an important lesson for us thinking about how we’re then going to scale this after the trial, because the goal here is not just to have something that’s a research intervention. We’re trying to create something that could actually be pushed out and scaled so that anyone could access it. And when we were looking at the literature, we realized that major issues that were limiting the scalability of prehab interventions were related to the fact that either the interventions were way too hard and therefore most people couldn’t do them.

So for example, in a bladder cancer patient population asking them to do high-intensity interval training before cystectomy, that’s just not something that’s going to be pragmatic for a patient population that has oftentimes a very high burden of other illnesses or what we call comorbidity, a very high burden of frailty, or decreased physical function. Patients with bladder cancer oftentimes have lower levels of physical fitness related to these other comorbidities. And so asking them to get to the gym and run on a treadmill or lift heavy weights or as I joke in some of my lectures, I don’t need people to flip tires. I need people to be able to get safely from their bed to the kitchen to the bathroom. And so we really need to think about pragmatic interventions.

We also need to think about, are we teaching to the test? So again, I don’t need people to be able to develop big beach muscles. I do need patients to have really strong abdomens and lower extremities so that they can safely transfer between chair to bed and stand, so that they can walk around safely without falling if we’re going to limit their core strength with an abdominal surgery. So, we need to increase their core strength and their balance so that they’re not going to have a fall after surgery that could set them back further or cause injury. So it’s really not about, we’re not training them for an athletic event, we’re training them for surgery, and so we need to make sure that we’re kind of, again, we call it teaching to the test, but thinking about developing balance and core strength and lower extremity strengths that people can get up and move more quickly after an abdominal surgical insult.

We definitely need to think about making it pragmatic. If somebody’s going to get chemo and they’re in the infusion center one or more times a week for the months before surgery, and then we say, “Oh, and by the way, you need to get to the gym three times a week,” and they live two hours from the hospital, that’s completely and utterly not going to work. But if we can do something that they can do easily at home, safely without any additional equipment that’s not going to cost them anything, that would be great.

And we also need to think about, I think, equity, right? So I really believe that this is something that everybody should have access to. And I take care of a lot of people who live really far from my center. So at the Fred Hutch, we’re the primary cancer center for five states, the WWAMI region. And I have a lot of patients who get their chemo in Alaska and then fly down for surgery and then fly back home.

Rick Bangs:

Oh my gosh.

Dr. Sarah Psutka:

And so, we can’t be asking them to buzz down to the gym three times a week so that we can watch [inaudible 00:20:52]. So again, we really needed to think about, okay, how are we going to do this pragmatically? And that’s where the digital innovations come in, and that’s where we start thinking about, how can we leverage these smart little computers that we all carry around in our pockets? So smart devices, phones and iPads, how can we leverage that? How can we leverage telehealth visits so that patients don’t have extra hospital visits, and how can we make it easy for people to do?

And so that’s where using what’s called mobile health applications, or in this case, and that’s sort of the overarching term for this Exercise RX application we’re using. We’re really trying to see, how can we do this as easily as possible in a way that patients are going to be able to do and are going to want to do? It’s not going to add burden to their days in their weeks while they’re going through therapy, it’s going to be something that they can integrate into their life. And maybe in some ways, we’re really hoping that we can set up some really positive habits for folks as they’re going through bladder cancer and upper tract urothelial cancer care.

So really, as we learned about all these kind of pragmatic issues, we really designed this trial with the goal of meeting those issues head on. And then of course, even as we thought we’d designed one of the most pragmatic trials we possibly could, we had to make it more pragmatic once we started and be really receptive to what patients were telling us, because we are still committed to being successful here.

Rick Bangs:

Okay, so I want to get an understanding of what’s included in the prehabilitation or of the prehab, right? So I’ve heard about the app. So I’m a patient, and I understand you’re going to customize this to me and what my current state is when I come in, what I can do, and where you want to get me. So, what kinds of things am I doing? The app’s reminding me to do them and kind of cataloging what I do, but what kinds of things am I doing?

Dr. Sarah Psutka:

Yeah, so the first thing is just step count. So walking is actually really important and the amount of time we spend active versus sedentary during our days is very important for building cardiopulmonary fitness, as well as muscle strength. Just the difference between sitting and standing using your muscles is really important. So the app’s going to, in the lead in period to the study for about a week before the study, patients wear a Fitbit and just carry their phones with them. And we just track how much they walk in an average day. And we take an average over about seven days, and that’s their baseline. So, your baseline step count may be some patients, the baseline step counts may be 3,000 steps a day. Some patients, it’s like 12,000 steps a day if they’re really active. Some patients who may not be very active, it may only be 1,000 steps a day.

So we start there, and every week the app gives you a target average steps of the day, and it gives you some feedback on that if you’re in the intervention arm. So, if you hit that 1,000 steps, let’s just take 1,000 as an example. If you take that 1,000 steps a day, if you get that to that 1,000 every day of that week with your app just kind of giving you a little ping saying, “Hey, great job you, you’re getting to the 1,000 steps,” the next week, it’s going to give you a 4% increased target and we’re going to increase by 4% every week, which is a pretty doable increase. So in that case, that’s only 1,040 steps.

Rick Bangs:

Right, right. That seems reasonable.

Dr. Sarah Psutka:

But over six weeks, that’s something that someone who’s going through cancer treatment can do. And so every week you’ll get that just incrementally slowly increasing step count. And then when you have your surgery, it actually drops down by 20% and we start from a lower baseline and then we begin that gradual increase again.

But then the other thing you’re getting in the intervention arm are these personalized exercise prescriptions that Dr. Hunter develops for a patient. So we have a menu of, I think at this point it’s between about 25 and 30 exercises, and we actually developed these exercises with our patient advocate for the trial. So one of my patients who had her bladder removed, who’s in her release, she and her husband worked with us and they actually were our models. And we have little videotaped examples of what each of the exercise looks like. And the interesting thing is we have the exercises at varying levels of difficulty, so most of the exercises can be done sitting, standing, or with a little bit of extra resistance for people who are actually pretty strong and don’t have a lot of deficits. Where we give them a Thera band, which is kind of like an elastic, stretchy band that gives just a tiny bit of additional resistance to help them build their muscles.

And the exercises are things that you can do at home with no additional equipment. So they might be things like arm raises or chair squats. There’s a bunch of core work that can be done sitting, standing, lying down. Some of the exercises are actually done in bed, so for people who have some real mobility concerns. So the idea is, even if you’re someone who actually gets around normally with an assistance device like a cane or a walker, we even have some… some of these exercises, we design them so that even patients who didn’t have a lot of lower extremity activity and sometimes need a wheelchair to get around, we could even help them, because the goal is here to create something that everybody can use.

Rick Bangs:

Right, right, not just Simone Biles.

Dr. Sarah Psutka:

Not just Simone Biles, exactly. And so the idea is these exercises, so Dr. Hunter then prescribes, she basically goes through the menu and gives patients kind of what they need. If they are specially noted to be vulnerable, say in their core strength or their low extremity strength or with balance maneuvers, she develops a program that she chooses about five exercises and gives them the prescription, which is the dosage, right? So it’s the number of reps, which is usually somewhere between eight to 12, and the number of times they need to do those sets, which is usually somewhere between two to three, of these four to five different exercises. So the whole program is designed to be done in like 25 to 30 minutes, and people can do it throughout the day sort of on their own calendar time, whenever it works for them.

And the idea is that when the app’s kind of open, you set the phone up in front of you and the app actually uses the vision capabilities of your phone to track your own movement. And so what patients see is they see the model who’s one of our patients doing the exercises that they then follow, and then they see a little avatar of themselves that highlights their body position so they can make sure that their body is kind of in the right location and doing the exercises correctly. And they get the immediate visual feedback of what they’re-

Rick Bangs:

Wow.

Dr. Sarah Psutka:

… supposed to be seeing. It’s helpful on our end because this also means one of the big differences between this trial and a lot of exercise trials that have been done to date, is a lot of exercise trials before did require patients to go to a gym and be watched doing the exercises so that we can say, “Yes, this patient did the exercise.” But again, that’s not pragmatic.

So we needed a way to be able to look at what’s called adherence, which is patients actually doing the exercises in a way that was privacy protecting, so patients could do it at home and the privacy and the safety of their own home. We also wanted patients to get feedback and have a, we didn’t want to just say, “Hey, go do eight times three chair squats,” without giving them the experience of having a leader or a teacher or a model. And so, this gets at that having someone show you how it’s done, and then also us being able to validate that the exercises are being done. And on the back end we get that video feedback and it goes just into our server bank where we can then test the adherence and actually validate it for one of our feasibility outcomes for the trial.

The goal here is actually to get to a point where we don’t have to use video. We don’t have to collect the video from a scalability standpoint.

Rick Bangs:

Oh, yeah.

Dr. Sarah Psutka:

Because one of the things we’re hoping for is that all of our little iPhones and sort of smart devices actually have a sonar capability, it’s really interesting, and it can actually track movement without the visual input. So the goal is actually what we’re testing on the back end is a really neat engineering feat of strength, which is to see if we can actually validate the sonar use to test adherence, as opposed to using video, which would allow us to scale this even further and-

Rick Bangs:

Oh, wow.

Dr. Sarah Psutka:

… be able to provide real-time feedback to patients and say, “Hey, great job you did all your sets,” without the need for that video recording. So for the trial we do a video recording, but we’re trying to get to a point where we don’t even need that.

Rick Bangs:

Really cool, really cool. Okay, so let’s summarize who qualifies for the trial, and then I want you to tell me where patients can find this. So, I heard muscle invasive bladder cancer, upper tract and kidney cancer. Is that the general criteria to summarize?

Dr. Sarah Psutka:

Yeah, so it’s actually, it’s a little bit simpler than that because it’s-

Rick Bangs:

Oh, good.

Dr. Sarah Psutka:

It’s really meant to be anyone who’s getting surgery for cancers of the bladder or the lining of the ureter or the urothelium. So, we’re meeting BCAN’s target population, right? Because BCAN also, although it’s the Bladder Cancer Advocacy Network, they do support work for upper tract urothelial cancer and urethral cancer as well. And oftentimes, those disease spaces don’t get a lot of funding because they’re more rare.

Rick Bangs:

Oh, no, that’s right, yep.

Dr. Sarah Psutka:

And it’s really important that we take care of those patients too. And like I said, the risk factors for those patients are pretty similar to patients who have bladder cancer.

Rick Bangs:

Sure.

Dr. Sarah Psutka:

We really wanted to be inclusive here. So really simply, the trial is for adults who are going to have definitive surgery for cancer of the bladder, the ureter, or the upper tract.

Rick Bangs:

Excellent.

Dr. Sarah Psutka:

So, that means they’re going to have either a radical cystectomy, and that could be for muscle-invasive or non-muscle-invasive disease, with or without systemic therapy. They could be having their distal ureter removed or their whole kidney and ureter removed upper tract disease, and then they just need to be willing and able to participate. There’s no other eligibility criteria.

And I should specify, we do need patients to be English-speaking for this trial, just because a lot of the survey instruments are in English, but we’re trying to develop ways, to develop, to allow, for example, the app to be translated and things like that. But we just don’t have that at this time. And this is obviously the first trial. But the goal is going to be to ultimately have it be more expansive than it even is, but really, it’s just adults who are having definitive surgery where they’re going to have their bladder removed, a part of their ureter removed, or their kidney and their ureter removed. And then with or without systemic therapy, and they need to be willing and able to participate. That’s it.

Rick Bangs:

Excellent. All right. So now, where can patients find this trial?

Dr. Sarah Psutka:

So right now this trial is being run through the University of Washington and the Fred Hutchinson Cancer Center, and ultimately, we hope to develop trials that actually will be able to be run at other places. And so it’s for any patient who’s getting care here at our place, and having their surgery done here.

Rick Bangs:

Yeah. Okay, so, so our listeners know, we’re talking about Seattle, Washington, right?

Dr. Sarah Psutka:

Correct. Seattle, Washington. Yeah, the Fred Hutch Cancer Center and the University of Washington in Seattle, Washington.

Rick Bangs:

Excellent, excellent. All right. Now tell me, how many patients do you need for the trial and how did you come up with that number, whatever that number is?

Dr. Sarah Psutka:

Yeah, good question. So this is a small trial, so we need about 100 patients, give or take, where our target enrollment is 102. And when you develop a clinical trial, we use what’s called a power calculation, which is a statistical way of calculating the number of participants we need to include so that we can make sure that we have enough people that we will be able to kind of answer the question. There’s a lot of complicated assumptions and calculations that go into this and there are different ways of doing a power calculation based on the strategy of your trial, the hypotheses you’re testing. But for the purposes of this trial, we based it on prior mobile health application implementation studies, as well as prior prehab studies.

And then one of the key points here, at the end of the day, what two questions do we want to answer? That’s a way of getting at what are the primary outcomes of the clinical trial. And we have co-primary endpoints, which means we have two things we really, really, really hope that this trial is going to deliver critical data on. One point is the feasibility of doing this. So it’s a feasibility study, which is measured based on how we recruit patients and how they’re retained within the trial and completion of the activities with the goal of patients completing more than 70% of the exercises among the intervention arm. And so that’s the feasibility endpoint.

The second is we’re looking at change in physical performance, and we do that with a short physical performance battery assessment, which is, it’s a less than four-minute physical assessment that is validated and used widely in exercise studies, as well as actually in a lot of geriatric studies that basically consists of three ten-second balance tests, which are very straightforward and easy to do, a quick four-meter walking test, which takes about give or take somewhere between two and five seconds. And then what’s called a five-time sit to stand, which is where patients are timed as they go from seated to standing. It’s basically like a chair squat, five times. So, we’re looking at how patients do from baseline, to the day of surgery, and then at the three-month mark, and we’re looking at the change in their performance on those three at tests. And that’s how we got to the number of 102.

So, the goal is to have 102 patients who we can evaluate, which means we’re trying to enroll up to 120 patients, because we expect that about 20% of patients will at some point need to drop out of the study just because of the nature of the study population that we’re working with. But 102 is kind of the magical number that we’re shooting for. And so far we have, as of today, we have 32 patients enrolled, which we’re really excited about, and that’s 32 patients who have joined our study over about give or take the last year and a few months.

Rick Bangs:

Okay, so you need another 90-ish, roughly?

Dr. Sarah Psutka:

Yeah, a minimum of about 68, but up to about 90.

Rick Bangs:

Yeah. Okay. All right, so if we have listeners in Washington, this is something you may want to consider. All right, so let’s suppose I’m your patient, I have agreed to join the trial. What would that involve? Because so far I haven’t heard anything that seemed like it was impossible for me to do or require skills that I wouldn’t have. So, what do you need from me?

Dr. Sarah Psutka:

That’s a great question. So, we’ve tried to make it as easy as possible, but basically once patients agree to participate, they’re given an informed consent that describes the trial activities and our safety considerations and all of the data safety, because one of the big things about joining a clinical trial is patients, we worry about how their information is going to be handled and we’re very careful to protect patient’s confidentiality. So, they learn all about that.

Once they sign the informed consent, they are randomized through a computer program to one of the two arms, either the prehab arm or the standard of care arm. If they’re in the standard of care arm, they get a Fitbit and one of our study team members will work with them to load up the app on their phone. And then that’s kind of it, because at that point they’re given the moving through cancer recommendations, but we just basically encourage them to do all of the things that their study, their normal clinical care team recommends to get through treatment and surgery and recovery as best they can. But there’s nothing else that’s needed on their end beyond, we do surveys at baseline before surgery, and then at that three month after surgery mark where we are assessing their quality of life, we’re looking at how they’re feeling and basically also doing, it’s a self-reported geriatric assessment evaluation, which is a very brief assessment of their physical function. So, there’s about give or take 20 minutes of paperwork that they fill out.

Now, if they’re in the prehab arm, they do the same thing after informed consent, they get the Fitbit, which we give them for the study, and we work with them. Our team does all the tech, we call it tech onboarding, which is where they help patients load up the app and show them how to use it and how to interact with it. And then there’s one additional visit for the prehab team, and that’s where they have a visit either in person or virtually over telehealth with our physical medicine and rehab doctor, Dr. Hanna Hunter. And then she will do about a 45-minute assessment, and that’s where she develops the exercise prescriptions. And that, like I said, that visit can, we try to stack that visit with one of their routine clinical visits if they’re coming to either the Hutch or U-Dub, but if they’re actually not coming back because they’re doing everything from Alaska or Idaho or wherever they might be, or Eastern Washington, then we do it virtually over telehealth.

And then once that’s done, basically about four to six weeks before their surgical date, the exercise prescriptions start coming in and we ask them to do their exercises and they also start getting this slowly increasing step count. Then both groups have surgery, the standard of care arm is encouraged to recover, as per our standard routine care here at U-Dub and the Hutch. And then the intervention group about two weeks after surgery, they start receiving notifications again about their goal step counts, and those will slowly increase if they meet those goals. If they don’t meet the goals, the goals just stay the same. And then they also will get the instructions about a modified exercise prescription that can be done starting two weeks after surgery with the goal of, again, focusing on redeveloping core strength, lower extremity strength, and balance.

And then at 90 days, there’s another follow-up set of studies for both groups. And then on the back end, we are tracking all sorts of metrics in terms of how the app is functioning, if patients are having complications with the app in terms of it not working. We are carefully monitoring for any side effects of exercise and any complications of exercise. So every week, the exercise arm, we ask patients, “Are you having any new problems that we need to know about?” And if they are, we immediately talk to them about it. If patients are having trouble just using the app, that’s actually an important endpoint for the study for our feasibility arm. So our engineering team is constantly troubleshooting any issues that may arise.

And then for those patients who are interested, at the very end, we have what are called exit interviews where patients can tell us more about their kind of qualitative experience with participating in the study.

Rick Bangs:

Excellent.

Dr. Sarah Psutka:

So, that’s a detailed description. The short and the long of it is, once you enter the study, if you are randomized to the prehab arm, there’s one extra visit that can be done virtually, and then the research team kind of helps you get everything all set up. If you’re in the standard of care arm, there’s no extra visits, you just have to wear a Fitbit and carry your phone. And then there’s the questionnaires, which are done three times throughout the whole thing.

Rick Bangs:

It doesn’t sound incredibly onerous, which is great from a patient point of view. All right, so you’ve got 32 patients. When did the first one sign up and when do you expect the last one, which is somewhere around 100 and something, 120 maybe. When is that last patient expected?

Dr. Sarah Psutka:

We had our first enrollment just at the very end of 2023. So we received the funding in the late spring of 2023, and then it takes about six months to get a trial like this kind of going through all the regulatory processes. So things like getting approval by our internal review board or the IRB, which reviews all patient facing studies to make sure that they’re safe and ethical. We had to build all the data collection programs and things like that.

The other thing we had to do was the app had originally been developed for other patient populations like pediatric groups and trauma populations. And obviously, we are now going to be using this app for a patient population that is going through treatment for cancer. So actually before we started the trial, we did a, we called it phase one of this phase two, three study, which it was not a phase one clinical trial, but it was a run-in where we met with about eight patients and then two surgeons. So these patients had previously had radical cystectomies, and we showed them the app and we walked them through the protocol, and we made sure that the protocol was acceptable to them. And we also got feedback on how the app worked. Did they like it? Did they like everything from font size to where the buttons were to what they said?

So interestingly, the app had been kind of developed for more of a teenage population before, so we actually had to change a lot of the language to make it just more acceptable to a adult oncology population. So we developed it, and we’re using a version of the app that really has been developed with direct patient input to make it acceptable for the patients that we’re really trying to target here. So, that was a super interesting exercise and we’re actually publishing the findings on what we call barriers and facilitators to exercise during bladder cancer care. That paper is actually under review right now with the observations that we learned from those interviews with those patients.

And then to the end, we’re hoping that we will successfully finish enrollment by around the end of 2026, and that would mean that we would have data hopefully sometime in 2027.

Rick Bangs:

Okay. We’re going to look forward to that. All right. Any final thoughts?

Dr. Sarah Psutka:

I think that one thing, Rick, that you and I have talked about this before, but I think one kind of perspective I’ve been trying to share is that I really do think that this concept of prehabilitation and active recovery is something that should be available to all of our patients. And patients often ask me in clinic, they say, “What can I do?”

Rick Bangs:

I know I remember asking that question.

Dr. Sarah Psutka:

Right? People want to know, what can I eat? How can I make this easier on me? Because it’s a lot to go through. Exercise and nutrition, we didn’t talk about nutrition. This trial’s not a nutrition trial, but there are prehab trials out there that look at nutritional interventions as well. These are the kinds of things that patients can do to engage in their care and to sort of think about affecting positive change as they’re going through treatment.

And I think one perspective I’ve really been working on thinking about how to, again, put some cold hard data behind, is that prehab is not just for people who are getting ready for what we call the marathon of your urology, which is a radical cystectomy. It’s also for people who are kind of training for our future race.

So I think about, I’ve got some patients, I have a big non-muscle invasive bladder cancer practice, and I get a lot of those patients onto prehab programs. They’re not in this trial, but we are actually waiting for an announcement to see if we get funding to run a trial in that patient group. Because patients who are going through BCG or going through intravascular chemotherapy, or just on surveillance for their low risk non-muscle invasive bladder cancer, there’s a chance that at some point they may have to go through one of these surgeries. So, it’s a great opportunity to start thinking about how we can get people fitter and healthier, even if they don’t have sort of an imminent need for a physiological stress. And I definitely think that prehab is something that really has potential value for all patients.

I think about one of my patients who is really wonderful, nearly 90-year-old gentleman, who’s had non-muscle invasive bladder cancer for years and he started doing prehab a couple years ago, and he was quite physically frail at that time. But he has joined a local Y and he goes to exercise classes a couple times a week, and he basically stopped needing an assistive device to get around.

Rick Bangs:

Wow.

Dr. Sarah Psutka:

And unfortunately, he sustained a stroke recently, but what was interesting was that he recovered remarkably quickly from it, and he and his wife both have commented to me about how they felt that a lot of that was due to the fact that he was so physically robust when he had the stroke. And so, he actually got out of rehab a lot faster than he was expected to. And obviously this is an anecdotal observation, but there are a myriad benefits to exercise. I mean, I see it, I try to be physically fit and I know you do too. We talk about these things, like how exercise just helps your… There’s a lot of benefits in terms of emotional benefits. There’s a lot of benefits in terms of obviously cardiopulmonary and strength benefits. There’s cardiovascular benefits, if patients maintain healthy weights, they’re less likely to see really significant complications related to comorbidities. So, it sounds maybe a little silly for a urologist to be telling everybody that they need to get fit.

Rick Bangs:

Yeah, it’s usually the colorectal people or the cardiac, the cardiologists.

Dr. Sarah Psutka:

But honestly, it’s something we probably all need to hear a little bit about.

Rick Bangs:

Yeah, exactly.

Dr. Sarah Psutka:

[inaudible 00:47:12]. I talk to my kids about it, but I do think that the thing, the message I kind of shout from the rooftops is I do think there’s a role for prehab for everyone, and I do think that it’s a great way for patients to engage in their care and start thinking about how they can kind of build their resilience, in terms of whatever stress is coming down the pipeline. If there’s an immediate stress in front of them, like a radical cystectomy, but maybe it’s not. Maybe it’s a big stress in a couple of years that they don’t yet know about.

And then the other thing is we’re trying to see if we can expand this program to patients who have more advanced disease. And so we have another funding application to see if we can run a trial in patients with really advanced disease who are getting treated for metastatic disease, because those patients warrant the opportunity to work on their fitness and their physical function as well, because it’s all about promoting independence, survivorship, and quality of life kind of across the spectrum of care. So, that’s my soap box.I hope someday that we’ll have lots of hard data that we can share that will support pragmatic ways for patients to integrate these kinds of tools into their daily life.

Rick Bangs:

Yeah, you’ve really nicely explained the universality of what you’re doing here, so that’s wonderful. So, Dr. Psutka, I want to thank you for explaining your BCAN-funded Get Moving trial and what you’re hoping to accomplish with it.

Dr. Sarah Psutka:

Well, I’m so thankful to you for the opportunity, Rick.

Rick Bangs:

Oh, my pleasure. If you’d more information bladder cancer, please visit at the BCAN website, www.BCAN.org. In case people would like to get in touch with you, could you share your Twitter handle or any other information you’d like to people have?

Dr. Sarah Psutka:

So my Twitter handle is at my first initial and last name, so SPSUTKA MD, and we are always thrilled to talk to folks about ways to seek these opportunities. And certainly, if there’s any interest in this trial, we’d be delighted to talk to you. We’re so excited about it and really hoping that we can be successful in enrolling fully so that we can get the data out there and think about next steps.

Rick Bangs:

Excellent. Just a reminder, if you’d more information about bladder cancer, you can contact the Bladder Cancer Advocacy Network at 1-888-901-2226. That’s all the time we have today. If you like this podcast, never miss an episode by clicking on the subscribe button on your favorite podcasting platform. Thank you for listening, and we’ll be back soon with another interesting episode of Bladder Cancer Matters. Thanks again, Dr. Psutka.

Dr. Sarah Psutka:

Thank you.

Speaker 1:

Thank you for listening to Bladder Cancer Matters, a podcast by the Bladder Cancer Advocacy Network, or BCAN. BCAN works to increase public awareness about bladder cancer, advanced bladder cancer research, and provide educational and support services for bladder cancer patients. For more information about this podcast and additional information about bladder cancer, please visit BCAN.org.