Health Related Quality of Life After Radical Cystectomy | What a large study tells us about the “new normal” after bladder removal.

February 16, 2022

With Dr. Bernie Bochner and Rick Bangs

You can read the entire Health Related Quality of Life Study webinar transcript at the bottom of this page.

Year: 2022

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Part 1: Understanding the Demographics of The Health Related Quality of Life Study

Video (15 min) | Transcript (PDF)

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Part 2: What were the Results of The Health Related Quality of Life Study?

Video (29 min) | Transcript (PDF)

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Part 3: Question and Answer about The Health Related Quality of Life Study

Video (17 min) | Transcript (PDF)

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Full Transcript

Stephanie Chisolm:

Welcome to health-related quality of life after radical cystectomy. Today, we’re going to look into what a large study tells us about the new normal after bladder cancer. So bladder removal surgery, or a radical cystectomy is the gold standard of treatment for many people with high risk bladder cancer and BCAN often gets questions about, what would my life be like after cystectomy?

Today, we’re really delighted to have Dr. Bernie Bochner and other experts. He’s representing the Memorial Sloan Kettering to talk about the long-term impact of bladder removal surgery on a patient’s quality of life. We’re also really happy to have voice of Bladder Cancer Matters, patient advocate, Rick Bangs here to find out what the surveys and interviews of more than 400 people tell us about longer term quality of life with an ileal conduit or a continent urinary diversion. So welcome, Dr. Bochner. And welcome, Rick. It’s nice to have you both here.

Stephanie Chisolm:

Well, Rick you talk about in Bladder Cancer Matters that you’re a proud owner of a 2006 model neo-bladder. Let’s start with you. That’s quite a surgery. What were some of the concerns that you had about how your life would change before you had a radical cystectomy?

Rick Bangs:

So I think for me, radical cystectomy was my second surgery in my entire life, so obviously I had concerns about surgery, but I think there are three things that I was concerned about in terms of my quality of life. The first, is that I had very significant concerns about self-catheterization. I would say, almost, I was freaking out. It was just something I just couldn’t imagine myself doing. The second thing is obviously I was concerned about continence because I was going to have a neo-bladder and would it retain urine? And how is this thing going to work? And how well was it going to work? And I think the third thing for me was sexual function and how that was going to work or even if it was going to work. So those would be my three major areas of concern as a patient.

Stephanie Chisolm:

Right. And those were things that were covered in this study. So Dr. Bochner, congratulations on getting this published. It’s a really important study to look at the long-term quality of life of patients who go through radical cystectomy. As a urologist at Memorial Sloan Kettering Cancer Center, you’ve done a lot of radical cystectomies in your career. Why did you think it was important to do this study? And what did you hope to learn by surveying all these participants?

Dr. Bochner:

Stephanie, great question. First of all, I want to thank you and Rick and the whole BCAN group for putting this really important discussion together. A lot of us in the medical field, treating bladder cancer spend a lot of time focusing on the cancer management side of things. Obviously our number one goal here is to get this cancer out, treat the entire body and really try to provide people an opportunity to walk away from this. But as you do more and more of these surgeries, you recognize that it has the potential for a lot of changes in people’s lives over time. And as we’ve gotten better with delivering more effective therapy, we see people living longer, more people living longer, and our second goal is to make sure that they can go on and live full and productive lives, to get back to the things that they want to do.

Dr. Bochner:

And as we look back at sort of the previous evaluations of how quality life is affected after a surgery, you realize that there’s not a lot of great data available. And in large part, it sort of stems from the fact that there are not a lot of great tools to be able to kind of help measure that quality of life, especially given the diversity of people that will have this disease and undergo care. So Rick is a perfect example, probably of the sort of prototypical person that would have bladder cancer, a male, much more common than female. And usually folks in their mid sixties or so is typical when bladder cancer gets diagnosed, but obviously it can happen in women, it can happen in younger people, it can happen in much older people. And there are so many different things that are happening in people’s lives.

So to ask the same questions, for instance, in a 40 year old, married woman, with younger kids and a job and a husband and the concerns that she may have undergoing a major surgery compared to, let’s say somebody who’s in their late seventies, who’s a male, he’s retired, maybe he’s lost his spouse at that point, he’s not working anymore. So the concerns are so different. And what we need as physicians is to be able to better understand the specific concerns that people have. And then we could begin to sort of address how surgery ends up affecting them. I think in the past, the perception was that this kind of a surgery led to a big black hole. As Rick had mentioned, there’s so many unknowns when you take somebody who otherwise is relatively healthy, maybe hasn’t experienced a major health issue and hasn’t undergone a major surgery. It’s like, what’s on the other side of this? And one big aspect of doing the study was to provide not the doctor’s interpretation of what is happening, but to use actual feedback from the patients, right? So that was kind of how we designed the study.

Stephanie Chisolm:

Great. Well, we’re really excited to learn more about it. So why don’t you go ahead and share your screen and give us some high points and any surprises that you found as you did the study.

Dr. Bochner:

Okay. So this is a study that had recently been published and a current fellow of ours, Matt Clements had been terrific at helping to put a lot of this data, but this is really a study that we had started back in 2008. Took several years to accrue. This was all done at Memorial Sloan Kettering. So it’s our institutional evaluation. And basically the people that we wanted to enroll were everybody who is eligible for a potentially curative, radical cystectomy, whether they received chemotherapy before surgery or not, they were eligible to enroll. We know that the choice of a reconstruction of the urinary system can be a very personalized decision. And it’s kind of a shared decision between a patient and the physician. So it’s not randomly assigned, but the choice of diversion was really per the standard of care between the patient and their doctor.

We used a whole battery of what’s called validated patient-reported outcome measures. And so these are a series of questions that have really been studied and have been shown to be able to provide consistent information in the way people answer the questions. And we’ll show you the various measures that we used. One of the unique natures of this particular study is that we got sort of how people were doing before their procedure. So it wasn’t a snapshot after surgery, how you’re doing, we really got a baseline measurement. So we got a sense as to what the changes were after surgery itself. The immediate period, right after surgery, as you could imagine, undergoing any kind of major surgery there’s a recovery period from the surgery itself. And that’s been pretty well documented following radical cystectomy. And most of the time complications and things like that pretty well collected up to about 90 days.

Dr. Bochner:

And so what we wanted to ask is, well, let’s see what happens after that? After people get over that kind of expected recovery from the surgery itself, how do they go on to rejoin their lives? And so what we did was we use these measures at three months, six months, one year, a year and a half, and then two years after surgery. We figured that that really kind of gave us a pretty good sense as to how things were covered. And what we did was we enrolled 550 patients, so pretty large study. And at that point, we needed baseline measurements. Some of the patients did not fill out all the baseline measurements. And so the eligible group for the analysis was a little bit lower. Ultimately, what we were left with was about just over 200 patients that underwent ileal conduit, urinary diversions, that’s the diversion that requires the external bag. And about 200 patients that had continent diversions, the vast majority of those were neo-bladder patients. This is the reconstructed bladder to the urethra itself.

I’ve listed here some of the measures that were used just to kind of show you the diversity of things that we were looking for. So there are standardized, validated measures if you will, that measure different parts of quality of life. And they can include things like sexual function, and there’s separate measures for females and for males, measures of urinary distress or incontinence, bowel function, because the GI system can be affected by the surgery. And then we looked at other things like decisional conflict scales, or satisfaction with life, fear of recurrence and other mental health inventories. So it was a real sort of diverse look using a variety of measures to try and identify kind of how people are doing overall.

The study was to designed look at the two groups of diversion patients differently, okay? And it wasn’t really to compare, how did the continent diversion or neo-bladder patients do to the conduit patients? It’s because they’re different groups of patients. There’s a selection process as to who gets what. And so we know that in general neo-bladder patients are going to be younger. And in this study, they were actually 10 years younger than the patients undergoing ileal conduits. The continent diversion patients were more likely to have better renal function, fewer underlying illnesses. And because they had healthier kidneys, a greater percentage of patients getting neo-bladders actually received chemotherapy prior to surgery as well, okay? In contrast, as I mentioned, the patients getting ileal conduits were a little bit older, they were more likely to have undergone previous washings within the bladder, intravesical therapies, there was a greater percentage of folks that had had pelvic radiation therapy. And so maybe that was one of the selection criteria for the conduits, and they were more likely to have pelvic surgery in general as well.

So just if you kind of look at the groups, you can tell that they’re quite different. So really what we wanted to do with this study was to show more of the trajectory after surgery, as opposed to separating the groups for direct comparison. So I don’t want this to be looked at as, well, continent diversions are better or worse than conduits. That’s really not what this particular study is designed to answer.

So these plots here, basically these are called spider plots, but basically what we’re trying to do is put a huge amount of information on these graphs here to try and get a sense as to how the baseline measurements of quality of life also differed between the two groups, right? So we have kind of a younger, healthier group of neo-bladder patients, many more that got preoperative chemo versus an older group, maybe a few more medical complications in the ileal conduit group. And a couple things stood out in the baseline measurements that showed that there were also some major differences. Sexual function, for instance, was really significantly different between the two groups. As you would expect, the younger men had better sexual function, overall satisfaction with their sexual function compared to the older group of folks. The ileal conduit patients, prior to surgery, had greater degree of urinary voiding symptoms, again, not unexpected in an older group of men. So again, these were kind of important baseline differences to take a look at.

Dr. Bochner:

I think it’s important to mention that the majority of folks in this particular study are men. And that’s not unusual because men are much more likely to get bladder cancer and undergo treatment for it than women. It’s more common in men. And so, not unexpected that we would have that higher male to female ratio. If I pause there for a minute, Rick, maybe I could bring you in and see if there’s any questions or Stephanie, with respect to maybe how the study was designed and then we can get into maybe some of the outcome results.

Rick Bangs:

Yeah. So, you raised this incredibly important point about baseline. And so is it unusual to capture a baseline when people in cancer research do these kind of studies? Because I’m not aware that it is. And I think it’s such an important point.

Dr. Bochner:

It certainly is logistically more challenging. What tends to happen, and it still provides some useful information, is that snapshot, right? So let’s see how folks are doing three months after surgery and we can measure that in everybody. This type of study, it took a lot more effort because now you’re longitudinally following folks. And you can see that even though 550 had agreed to join the study, there was a group that missed a fair number of the baseline measures. And so that was kind of anticipated. Not everybody, even though they have good intentions, they may not necessarily feel up to filling these out. And so that’s why the numbers of folks begins to drop.

I think it’s also important to recognize that not everybody follows the same course during their treatments, right? I mean, some people go right to surgery and other people may have spent several months receiving systemic chemotherapy before they went to surgery. During the follow-up period, everybody may follow a little bit different course as well, right? We hope everybody’s cured and no additional treatments needed, but we know that some people may require additional care afterwards. And if their tumor comes back, that can also affect their quality of life as well. And in a subsequent study that we’re working on, we’re trying to figure out what those effects are as well. So there’s a lot that’s kind of happening as you march people through treatments, and it makes this kind of a longitudinal study a bit of a challenge to do.

Stephanie Chisolm:

I have a quick question too, Dr. Bochner. You did the study on the population at Memorial Sloan Kettering, and you do talk about the continent types of diversions, that includes the neo-bladder as Rick had, and also the Indiana Pouch type of a diversion. So do you see that you end up kind of 50/50 Memorial Sloan Kettering? Or is it really dependent again, on that age and stage and overall health of that individual?

Dr. Bochner:

Yeah. It’s a great question. Who gets what? And why do people get that? So if we took a step back and we said, nationally, if we looked at the numbers, we know that probably on a national basis, only about 20% of patients get continent diversions. 80% of folks still are receiving ileal conduits. And unfortunately, that number has sort of been stubbornly stuck at 20% for quite a while, but it does vary from institution to institution and even within institutions it’ll vary as well. So a lot of it has to do, I think with surgeons preference, their comfort level, their experience, their training. And so it varies. So in my practice, I can say that probably about 70%, 75% of patients receive a continent diversion, and about 20% to 25% to 30% maybe receive an ileal conduit. But that can vary. At our institutional level, it actually does turn out to be about a 50/50 split. But it does vary from institution to institution.

Stephanie Chisolm:

Right. Okay. This is great. And as far as having a lot of men participating in this survey, we know that the number is kind of equal to the incidents in the male versus the female population. But when you’re going through and going to talk about all of these different changes that people saw over time, how can we tease out, because we know women do get bladder cancer, they’re often diagnosed usually after some misdiagnosis or just a long trail of other treatments before they get to their diagnosis. How can we see this information conveyed to women as well as to men? Is this kind of thing that is representing really the overall population?

Dr. Bochner:

It’s an excellent question. And so, because the numbers of women in many of the cystectomy series of patients that have been reported tend to be, it makes up the minority, it’s maybe about, maybe 20% of the overall group of folks. And that kind of is where that number falls here in this series as well. What we’re currently doing is we’re taking a very detailed look at the subset of women that had undergone surgery as well. And one of the things that we included here was the female-specific sexual function measure for women and the male-specific sexual function measure for men. And so we have that information. And maybe even at a subsequent meeting, we can kind of go through the specifics for women because many of us really feel that we need to spend a lot more time and interest focusing exactly on sexual function and outcomes in women and that are undergoing radical cystectomy.

Dr. Bochner:

So what you see here, I think, and what I can tell you is that when we look at male and female, the global quality of life, a lot of physical functioning, bowel, the kind of other functional aspects, which we’ll run through here is pretty consistent between men and women. The sexual function aspect is actually going to be… We’re writing up a completely separate evaluation of that because we think it really deserves its own attention. So it’s a very, very good point. But I think the takeaway for women who are listening to the webinar here, to the podcast is that these measures, I think for the other factors can pertain as well between men and women.

Stephanie Chisolm:

Great. Thank you. Well, we’ll let you get back to sharing this information for a little bit.

Dr. Bochner:

Excellent. Okay. So these are probably the most important visuals I think that people can use. And what this basically shows is again, we’ve separated patients that have undergone the continent diversions in the blue and the people undergoing the ileal conduits. And again, we’re not really trying to compare the apples to apples here. I want you to focus more on the trajectory, what happens over time? Okay? So if we look at sort of the top graphs here, these are measures basically of global quality of life. And what we would hope not to see would be that from baseline to those early measurements, a huge drop-off, right? Lower numbers here would represent major hits in global quality of life. And if it never recovered back up to that baseline, that would be what we would be most concerned about, right? That’s telling us patients are taking a huge hit and they’re not recovering.

Dr. Bochner:

And what these 400 plus patients told us is that simply not what they’re experiencing. So if you look at the area here, these are their baseline measurements, and this is now the continent diversion group, looking at their global quality of life. And what you see is you don’t see that major hit to quality of life. People are just simply not purporting that. And in fact, it continues to get a little bit better, or at least stays at the baseline as time goes on out to the 24 months. And this is basically the exact same thing that’s seen in the ileal conduit population. So here’s their baseline global quality life measures. Keeping in mind that higher scores mean better overall quality life. And you don’t see that major drop. People are not reporting that. And they’re able to maintain their baseline quality of life throughout the study.

If we look at measures of physical functioning, okay? So higher scores here mean better ability to perform physical activities. This is exactly what you would expect, right? So after major surgery, people’s ability to perform their physical activities does take a drop, right? And I’m sure Rick could speak directly to that. But after they get beyond that first three to six months, what we see in the continent diversion group is that they get back to their baseline level of physical activity. We see this same drop in the patients undergoing ileal conduits. It’s a drop, but it’s not a massive drop in their physical activity, but it’s definitely a drop. And then over time, it gradually begins to make its way back to baseline. Again, same thing that occurs in bowel function, okay?

Now, why would bowel function be interrupted? Well, it’s an intra-abdominal surgery when the bladder is removed and the reconstruction is done. The urinary reconstruction uses a segment of the intestinal system, whether it’s an ileal conduit or a neo-bladder or some sort of continent reservoir that’s catheterized. And so what we see here is that there is a slight drop in bowel function reported in the early parts of the recovery. And again, I think that most people who’ve undergone surgery would say, “Yep, my bowels were a little out of sorts there for the first couple few months,” but then they get back to what they report as sort of their baseline level of function. In the ileal conduit patients, you can almost not even discern much of a change in bowel function over time, and it stays stable as we move on.

Stephanie Chisolm:

Yeah. I just asked a question about that because the neobladder, for reconstruction that way, uses a larger portion of the intestines. Do you think that has something to do with why there’s more of a dip there in bowel function than there is in the folks with the ileal conduit?

Dr. Bochner:

Yeah. It absolutely may be. And again, I think that if you… You can see and numerically we can identify there is a little bit of a drop-off here, but what’s very satisfying to Stephanie is that we don’t see a major drop-off, right? Where we see this pressed down to these levels, which would really be significant bother due to their bowel function. So no question things change. I think that it’s absolutely reasonable to assume that because a little bit larger segment is used for these internal reconstructions, that they may take a little bit more time to settle down. But I think it’s important for folks to recognize from these three panels, what this told me is, number one, there’s going to be a recovery, there’s going to be some time, you’re physically going to need to recover from the surgery, but you are not going to be devastated by this operation, that your quality of life is going to remain high.

And that once you get through the early part of that recovery, there’s every expectation that you’re going to be able to get back to the physical activity that you were doing at baseline, your global quality of life is going to get back to baseline, and that your bowels are going to take a little while, maybe to settle, but that’s not going to be what drives a lot of the problems following surgery, which was, again, I think really important information for us to see. Honestly, this is what I’ve been seeing for a couple of decades now doing this, but it was very gratifying for patients now to be able to see this. And now I can tell you, this is what patients report. So these are very reasonable expectations. Well, what about some of the other nonphysical aspects? What about mental health, for instance?

Dr. Bochner:

And so here now, again, higher scores mean better mood, improved anxieties, improved levels of an anxiety, and you can see that, here’s baseline, obviously people are stressed moving into surgery and a little bit of the unknown, and you can see that rather quickly, mental health scores are reported as better, and they stay stable if not improve a little bit for both the conduit or the continent diversion, as well as the conduit patients as time goes on, okay? Social functioning. I think this is another really important aspect that many people have moving into surgery. Am I going to be able to get back to work and interact with my colleagues? Am I going to be able to have good interactions with my family and my children, grandchildren? And that’s exactly what we see here. So higher scores again, mean less interference with social and family life. And following this lower baseline measurement in the continent diversion folks, you could see this steady, nice increase and it actually returns to a level above their baseline.

Now, interestingly in the ileal conduit patients, we saw that social functioning actually was a little bit better at baseline. There was maybe a little bit less interference at baseline, the reports, with their social and family interactions, but that did change a bit. So they did see a drop in the early periods, but by about six months, that began to return back to their baseline levels, okay? So a little bit different again, and this may represent just the differences in the age of the patient, the overall health of the patient. It may be that it is a little bit tougher for people who are average age 72 compared to average age 62 early on undergoing this type of a surgery.

Stephanie Chisolm:

When I ask, did you tease out or have any opportunity to interview to really understand, for instance, maybe that change in social function for patients with an ileal conduit, until their comfortable and confident in how to manage that appliance might have something to do with anxiety about having a leak or we talk about this, we hear from patients all the time that they’re worried about having a leak or what if somebody knows that they have a bag and that limits their outside activity. Have you done any deep dive into some of that with maybe follow-up interviews with participants?

Dr. Bochner:

So the other aspect of this study, not represented by this data, was a separate, what we call idiographic evaluation, which is an interview technique. So these standardized forms basically are exactly that. They’re forms. They’re predetermined questions with various scales that people can answer. So Stephanie’s making a very important point, which is you get a lot of information, but you’re only getting what you’re asking and you are limited because it’s a set question and answer. And we recognize that. And one of the early collaborators in this study had a particular interest in this interview technique, in which open-ended questions are asked to folks, and then their responses are recorded and then coded. And so we have an equal mountain of data, of interview data that actually is undergoing analysis right now. And we have begun to start getting some information out through that. And I can tell you that a lot of that information is additive to what we get from the standardized forms.

Dr. Bochner:

And so it’s incredibly important to recognize that while many of these forms are validated, and this is what’s available, there’s so much more that patients want to tell us. And it will vary from person to person. And so super important. But to specifically answer your question, why maybe are we seeing the social functioning drop, it could be related to this. And so these were the two domains, the two areas that we looked at that did not return to baseline, okay? And I want to focus on the bottom one first. The bottom ones focus on body image. So here, higher scores mean worse satisfaction with body image. So here, you don’t want to see the lines going up. And as Stephanie had alluded to, so here are the neo-bladder patients, continent diversion patients, where body image essentially is unchanged, maybe slightly improved by the end of the study. And that’s not what we found with the ileal conduit patients.

And this has been identified in other quality life studies done in patients undergoing bladder cancer, which is one of the things that is not necessarily going to favorably change in patients with external bags is body image. And here we do see increased scores, which correlate with worse satisfaction in body image. And you’re right. This may translate as well to concerns about how comfortable they are with their appearance, with the ability to control the bag itself, the urine from leaks, other things until they get settled. Interestingly, even after two years though, of using the appliance, the body image domains really never returned to normal in the ileal conduit patients. So this was one area where I think we need to try and make some improvements for folks.

The other area that also showed a change over time was sexual function, okay? So here now, higher scores mean better sexual function, lower scores mean worse. And you can see that whether it’s for the continent diversion patients or the ileal conduit patients, there is a drop-off in function, which basically is sustained over time, okay? Now, why is that? Well, it is interesting here. If you look at the baseline measurements of sexual function, what I could tell you is that these are probably not unusual levels of measurement for men who are at this age group. We know that overall men’s sexual function can decrease as we age.

We know that again, because there’s a 10 year difference between the continent diversion patients, younger, 10 years older in the ileal conduits, that their level of function is even more depressed, which again, 72 medium age versus 62. The other important aspect here is that unlike prostate cancer surgery, where we’re much more able to do nerve preservation because of cancer related factors, safer to spare the nerves and many men undergoing prostate cancer surgery, and they’re also in general, younger, we can see a higher degree of maintaining sexual activity. For invasive bladder cancer, high risk bladder cancer, nerve-sparing surgery, for many folks, we just simply can’t do because of cancer-related factors, where the nerve bundles are located in relationship to where the tumors are. And even if we do nerve-sparing surgery in many men where their function has already been depressed, it may not work quite as well.

Dr. Bochner:

So I think we can certainly physiologically understand this, but we’re taking very hard looks at each one of these groups individually, because again, this is just sort of the overall groups that you’re seeing. And within each one of these groups, we’re going to have very different populations of patients. You’re going to have some men coming into surgery with very good sexual function with a partner and an interest to maintain that. And those are the folks I think that we need to spend a little bit more time thinking, can we do safe nerve preservation surgery? And if not, can we provide alternatives, other erectile rehab options? Because that may drive a lot of their overall quality of life.

Dr. Bochner:

On the other hand, and maybe some older men who have already lost a fair amount of function, maybe they’re widowed, maybe they don’t have a spouse or a partner, where sexual activity is not what’s driving their overall quality of life, they may be more interested in getting back to being with their social group, maybe being able to get out and go golfing or play cards, or maybe go swimming with their group of friends. And so these are the things that we need to focus on to be able to kind of help them get better. But I think that these numbers are real, and these are things that we have to be able to show folks, “These are the things that you may experience after surgery.”

Rick Bangs:

So can I ask a question? So you’ve got this great data across time. In the interviews, did you get any sense, particularly from baseline to three month period, some of the fluctuations that happen between the points, because I mean, clearly you’re going to struggle with continents and leaks in that first three months. So you’re going to struggle more, I am suspecting with sexual function, the bowel issues that you mentioned earlier. So did the interviews tease out any of the kind of fluctuation between the baseline point and let’s say three months?

Dr. Bochner:

Well, so three month is really the first evaluation that we did here, right? And Rick, again, I think you have this unique perspective having gone through this, you know that there’s a lot going on in that first three months.

Rick Bangs:

Yeah, exactly.

Dr. Bochner:

Right? I mean, the first month you’re trying to figure out up from down, trying to get your bowel settled and you’re bouncing between constipation and loose stool and at the same time, your urinary sphincter is working on getting its tone back and your neo-bladder is ensuring its capacity. So you’ve got a pad that’s leaking, you’re trying to find the bathroom and you’re just exhausted, right? And so that sort of sums up the first four weeks easily, of the recovery. And we recognize that there is that early recovery period where I think people are just taking that major hit from surgery.

So what this study was really trying to focus a bit on, and we lost some of that early change that you’re referring to, is where we were asking, okay, so what’s next? Right? So once people really feel like, okay, you know what? I’m eating, I’m actually doing a full-day’s activities now, I can see the light, I’m getting more control now, maybe I’m down to a safety pad in case I cough or sneeze, or if you have a conduit, I’ve got this figured out. I haven’t had a leak in a good couple of months and I’m able to find a comfortable position to sleep on and I’ve got clothes now, I’m not so worried that everybody’s going to stop me and go, “Oh, you wearing something under your clothes there?”

And so that’s kind of when we wanted to sort of begin to start seeing what happened once people sort of made it through that initial tunnel. And we know that it’s a good three months, at least for many folks that are going through this. And so that’s when we started our measurements and we wanted to see. And we figured by a year, year and a half, a lot of folks have sort of settled in as far as their continents goes, if you had a neo-bladder, your nighttime control probably is continuing to get a little bit better even beyond that. And for the ileal conduit patients, for the most part, they’ve kind of figured out life with the appliance. For men, at that point, by year, year and a half, most of them have freed their wives from having to do all the changes for them. And they’ve learned how to take ownership of the bag and they’re doing the changes.

Dr. Bochner:

And so that’s what we really wanted to see. And again, it was quite gratifying to see that many of the really important domains are not taking that huge hit. People are really getting back to the things that they love with the caveat yet that this is not a perfect surgery, that there are some of these measurements, such as what we’re seeing here that are going to change and are going to take some adjustments. And fortunately, there are options from a sexual function standpoint and they’re different obviously between men and women, and there’s some adjustments that are going to have to happen, especially in body image if you have a conduit.

Stephanie Chisolm:

I have a quick question. You talked about the qualitative interviews and somebody is very excited about processing all of that data from those interviews. When do you think we might expect to see a publication on that? And should we start thinking about scheduling you for the fall to do a follow-up interview?

Dr. Bochner:

Well, it’s interesting. So we did take an early pass at some of that data and there’s been some information published from that, but we’re still working our way through a lot of that. And I’ll tell you a little piece of that data which I thought was fascinating. And as a surgeon who’s always interested in how my patients did, I, by no means would claim to be a quality of life expert. But fortunately, I surrounded myself from people who really understood this field. And one of the things that did come out is that people’s frame of reference on how they should be doing significantly impacted how they sort of navigated this whole experience, okay? So for instance, if people come into surgery viewing themselves as, the people I need to compare myself to are the 60 year old guy, my workmates, right? Who are all healthy and they’re working and running around, and that’s what I need to be like, right?

That’s kind of an unrealistic comparison for what they’re about to run through, right? Whereas if people recognize, okay, I’m about to have major surgery and I’m going to need to cut myself some slack. And now my point of reference is a previously healthy person about to undergo some major treatment. And it’s okay if I take a little break from being Superman or Superwoman for a while. As they begin to travel through that journey, they begin to accept things easier or becomes more difficult. So for instance, if they suffer a setback, they have an infection let’s say, after surgery, the Superman frame of reference, that really challenges them to be able to absorb some of that recovery, whereas people who have voiced to us that they recognize that this is a big surgery, it’s going to take some time to recover, but I’ll eventually get there, they were able to navigate things better.

And what that told me was the importance of being able to give people a realistic view of what this surgery is going to put them through, right? To not tell them that, “Look, it’s a six week recovery and you’re going to be back at work and everything will be great.” That’s not the reality. That doesn’t help folks, but to be able to say, “Look, here’s a realistic view of what this recovery’s going to be like, and you’ll get back to be the mother or the grandmother or the daughter. And get back to work and enjoy the things you want to do, but it’s going to take some time, okay? And you have to expect that you’re going to need a little bit of help maybe during this.” So setting expectations was really important.

Dr. Bochner:

And this was… Even though I kind of always sort of knew this as a physician, this was the first time to really show quantitative data on how setting those expectations realistically had impact on how people were reported their quality of life afterwards. So it’s that kind of interaction that we get, which we would never get from these validated questionnaires, that we got from the idiographic data. And so we’re working diligently through that. So hopefully by the summertime, we have some really nice papers that show them.

Stephanie Chisolm:

So with that in mind, you’re seeing these sort of level off lines here for these different characteristics that you looked at. Are there any plans to go at the 36 month mark or a five year mark back to those same people to see, are they really well adjusted five years afterwards?

Dr. Bochner:

Yeah, it’s a really great question. And this particular study sort of ended at the two year mark, but I do think that you’re absolutely right, that even some of the longer term data would be very important to show. Again, Stephanie, this is such a broad group of people that get this disease. We kind of think of it as the older man who’s been smoking for quite a while, but we see a lot of younger women who never smoked who like to run marathons who can get this disease as well. And what I feel is that they’re on such different trajectories that we should not really be asking them the same questions. And so one of the ways that we’re using this data, I don’t envision having to give 14 standardized forms to everybody and a multiple hour interview.

What we’re in the process of doing now is to take all this information and do what’s called an item reduction evaluation, to be able to really find out what are the key questions that we need to ask. And I’ve challenged the statisticians that we’re working with to try and personalize this, because I truly believe that that older widowed, maybe having some issues with his sexual function, retired male doesn’t need the same set of questions as that younger mother working with a sexual partner does coming into this. And so what we’re trying to design is what are the baseline questions that everybody would need to be asked? And then given their clinical characteristics, age, sex, partner status, sexual function status, things like that, that we can develop an algorithm that the next set of questions would differ.

One person would get this, because we know from this data that this is what’s going to drive their quality of life. Maybe it’s related to their sexual function. And in somebody else, maybe it’s all about financial worries, right? That they need to get back to work so they can support their family. And that’s what they’re worried most about. Or maybe it’s social functioning and being able to remain close to the people that are around them. I think knowing that and feeding that information back to the doctors, right? Hopefully we’ll be able to then put the support, individualized support in place to be able to improve people’s quality of lives in a more thoughtful way, at least that’s my goal. So that’s where we’re hoping to go with this as time goes on.

Stephanie Chisolm:

We’re slowly starting to pick through some of the questions that are coming in. And there was one that came in really early. And I just wanted to see, you were doing this study at Memorial Sloan Kettering in New York City. It is perhaps one of the most diverse locations in our country, because there are people from everywhere and of all races and ethnicities. Was there a good representation across race and ethnicity in this study that maybe you need to do a little dive into those aspects, see if there’s any differences in there?

Dr. Bochner:

So, a lot of referral centers, you’d be surprised that the group of people we end up seeing may not be as diverse as we would’ve hoped from a study standpoint, right? So a lot of minorities are underrepresented in this particular subset. A lot of these folks are Caucasians. We don’t have nearly the same level of African-American, Asian or Hispanic groups that will make their way into Manhattan for care. And I think that that’s probably not uncommon amongst a lot of the tertiary referral centers. And so we lack a lot of that. And so this brings up a really great point, Steph, which is that ultimately what we love to do is to develop this useful tool and then export it. And try and get that information at all different sites, right? At the referral center level, but also at the community care center level and the rural clinic settings, right?

Because, you’re absolutely right. Just because this group of people is telling us this at our center, this may differ from group to group and from site to site. And we need to collect that information, because we realize that the vast majority of cancer care in the United States happens outside of the academic centers. It happens out in the community. And so it does raise an interesting question, are these outcomes transportable everywhere? And the answer is, I’m not sure that they are. With all major surgical procedures, whether it’s Whipple for cancer surgery or the pancreas, or removal and replacement of the esophagus, any kind of major surgery, surgical volume at the center, surgeon’s volume can affect outcome, right? Experience of the surgeon, experience of the team can affect outcome.

What I would like to believe is that this is not specific to Memorial, that there are lots of very dedicated surgeons that we have in the United States and throughout the world who are focused on this type of surgery, on developing a team that supports people throughout the hospital care, throughout their postoperative care is a really big team that’s required to provide this long-term support. And it’s out there, it’s at different centers throughout. But I also hope that patients can see this and people recognize this. These should be your expectations, right? And I think that as you begin to look around where you’re going to get your care, it’s important to have this data, right? Not just to know that, I’m going to be okay, but you want to go to a place where you can feel reasonably comfortable that these can be achieved as well.

Stephanie Chisolm:

This is awesome. Rick, do you have any questions coming up? Because I’ve got a few more coming in.

Rick Bangs:

No, this has just been fantastic. And I love the opportunity for patients to kind ask questions and the doctors to kind of explore around these individual areas, because it kind of puts some context around what is quality of life, so. But no questions.

Stephanie Chisolm:

Right. And you did factor in people’s overall experience like, if they have a partner and some of those other things. And so I think that those are addressing some of the questions that are coming in. So that was sort of considered when you were looking at again, sexual functioning or even just quality of life when you’ve got somebody living with you. And so that was part of that initial… You had a diagram, a little chart that showed all the different characteristics at the beginning of your slides, I think. If I’m recalling correctly.

Stephanie Chisolm:

Yeah. So married and partnered. So it was a deeper dive. So there is that ability to look in there to see, do you have a partner who can help you out? And as you were mentioning, sometimes over time partners don’t have to do as much for the patient who might have an ileal conduit because they get more confident in changing their appliance and managing that. Obviously with a neo-bladder or an Indiana Pouch, these are some things that the patient needs to learn how to take care of for themselves. And so looking at it from that perspective, do you have a sense overall about how many women that are able to have a neo-bladder that come out of your quality of life study?

Dr. Bochner:

Yeah. I mean, I think that what we have found is there’s some very specific selection criteria that we use as for women who would be an appropriate candidate. And in large part, there are tumor factors that are associated with it. We have to make sure that the area where the bladder and the urethra comes together, that’s the area we’re going to divide at the time of surgery so we can remove the bladder. That area has to be free of disease. And so knowing that their cancer is away from that area is critical. That they have good urinary control before surgery, right? So their normal bladder and pelvic floor support is in place. And that they potentially have the ability to perform catheterizations if they need to, okay? So they have to have some manual dexterity to be able to do that.

We do know that women still have a little bit higher risk of needing to catheterize compared to men. We’re desperately working out the mechanics of why that occurs. But I think that if you meet those criteria, we tend to go ahead and offer the neo-bladders in women. And as we’ve reported and other series have reported that women do quite well, other than the increased for catheterizations. But I have found that in the women who have the manual dexterity to be able to do that, it’s an adaptation that they make. And again, as we saw in this data, the body image issues, which sometimes is quite important for many folks, not just women, but for men as well.

Stephanie Chisolm:

And women. Right.

Dr. Bochner:

Absolutely. That the trade-off of eliminating the external appliance to learn how to catheterize a neo-bladder, for many women, they’re okay with that. Drives me nuts because I’d love to see them all perfect and emptying on their own, but there is a subset that may need to cath, so. Yeah.

Stephanie Chisolm:

So I think it’s really clear that it does take time to get used to what we at BCAN often refer to as the new normal. When cystectomy is in order, when it’s the best type of treatment to have, it does take time to adjust to life without a bladder. I think what’s really important in your study is that there is quality of life even without a bladder. And so many people who are faced with that decision, that treatment decision don’t think, how am I going to survive without my bladder? And I think it’s really significant that you’ve done this quality of life study. We look forward to hearing more about some of these really qualitative aspects. And maybe again, we’ll schedule something for the fall. That’ll give you time to get some publications out that you’d be able to share with us. And I definitely will keep all of our participants aware of that.

Stephanie Chisolm:

So this is wonderful. I see that we are at time. Dr. Bochner, this has been fabulous. I really, really think this was a great presentation. And Rick, thank you so much for joining us as our voice of Bladder Cancer Matters. We know that bladder cancer does matter and we will be hosting a podcast with Dr. Bochner over the next couple of months. So, keep an eye out for that. And we’re going to develop a patient sheet that kind of does a summary, that’s really a lay language sheet of what the study was all about. I’m working with some of Dr Bochner’s fellows right now on helping to make that more a plain language for everybody.