Chapter 21: A Landmark Study on Chemotherapy and Depression
Dr. Fisch begins this chapter by explaining that as Chair of the Eastern Cooperative Oncology Group’s Symptom Management Committee, he wanted to study how to manage patient symptoms, but there was a lack of basic data about symptom experience. This led to a landmark study of more than three thousand patients that surveyed a broad range of symptoms and practice patterns for lung, breast, colorectal and prostate cancers. (He observes that such long-term studies sometimes fail, discouraging some researchers in the process.)
Dr. Fisch notes that the SOAPP study continues to make a unique contribution. An unusual feature is that the study has a website (http://www.ecogsoapp.com/) to facilitate dissemination of information. Data also is available through twelve published papers, with more coming. Dr. Fisch talks about the difficulties of maintaining the website when money runs out.
The Researcher; The Clinician; The Administrator; The Leader; Career and Accomplishments; Overview; Definitions, Explanations, Translations; Discovery and Success; Multi-disciplinary Approaches; Understanding Cancer, the History of Science, Cancer Research; The History of Health Care, Patient Care; Beyond the Institution
Michael Fisch, MD:
I felt similarly about an earlier study that was the ECOG SOAPP Study. ECOG, Eastern Cooperative Oncology Group, one of the other oncology groups that are now called network groups that I’d been working with since the time of my fellowship and where I’ve served as the chair of the Symptom Management Committee. Working with them and realizing that we wanted to do interventional symptom studies and we sometimes had trouble justifying those studies because we didn’t have enough pilot data about the symptom experience of patients. So an example would be right around 2000 or so, we were interested in studying the question of whether using an antidepressant would improve the symptom experience of patients who were getting treated for lung cancer with chemotherapy and radiation. Andrew Miller at Emory University, a psychiatrist and very interested in the biology of depression, he and his group had already looked at this idea of using antidepressants for people who were getting treated with Interferon for melanoma, and found that they had some better results. We thought, well, the sort of cytokine storm, the biological milieu when you give chemo and radiation had some real effects on the brain that could be mitigated by using antidepressants so that people would be having less depressed mood, less fatigue experience, better sleep, and might be able to even have better cancer outcomes because they’d be more likely to complete the full course of therapy at full doses. So we wanted to study that, and so we proposed that to the NCI and they said, “Well, that’s an interesting question, but here’s why we think it’s not ripe for doing the study. We don’t really know how often people getting chemo and radiation are depressed, and we also don’t know how often they already get antidepressants. So if that’s already the practice pattern, you won’t be able to enroll people and randomly assign them to an antidepressant versus a placebo.” So we thought, “Well, are you going to fund us to do some of the pilot work that gives us that information so we can do the study?” And they said, “We might consider that, although that’s not normally what we do in this mechanism, descriptive work, but if it’s fundamentally important to some of the research you want to do, we might do it.” Then we started to put together the symptom surveys, where we’d look at the symptom experience and the practice patterns, but then we thought, why do it just for lung cancer patients? Because this is not the only research we want to do. So why don’t we look at a broad set of symptoms, physical and psychological symptoms, and look at function and then look at all the prescribing patterns for pain medicines and nausea medicines, all kinds of things that people are prescribing or consults are asking for, like what are they doing, what’s the patients’ effects, and what are people doing about it? And then let’s not just look at lung cancer, but let’s look at the four common solid tumors: lung cancer and colorectal and breast and prostate cancer. And then we’ll just take people as they are, flowing through outpatient oncology, like who’s coming through outpatient clinics in the community and the academic centers, what is their symptom experience wherever they are in the course of their care, and we’ll do this on a large number of patients, and then we’ll have the data to plan whatever studies need to be planned. We will have enough data to not run into that kind of problem when we propose the next thing, and the next thing might be we want to study Dronabinol, sort of cannabinoid for nausea, and we’ll then be able to say this is how many people are already getting Dronabinol and this is how many people have nausea, and we’ll have something to say about all these things to help us plan the research. So the SOAPP study was ultimately put together and conducted between 2006 and 2008. These things take years. I mean, these are not meteoric career contributions. These things are part of your long-term portfolio, because for a long time you work on a study like that and you don’t even believe it’s ever going to happen, because you can just have call after call and negotiate, negotiate, and then sometimes it just never comes together. Many people have this experience in the group system, and they say, “I worked on some study for a long, long time and it never happened, and I feel burned by that, and so I’ve decided to never do that again.” So some people have that experience and they leave. I actually had experience like that earlier in my career, and it had to do with wanting to use Sildenafil, which is Viagra, versus placebo, for prostate cancer patients with respect to erectile dysfunction. And when I proposed it, nobody knew whether it would work for those patients, and it wasn’t commonly done, and the whole idea was would it work under that circumstance. But anyway, I got all that through and it was approved, and then we were working on it. And then the NCI changed its mind and withdrew its approval. That made me very frustrated, but I didn’t leave the system and didn’t stop trying. I came back to play again. (laughs) And ultimately, still at the time we were working on this study for several years, negotiating, writing one version, trying to see if the group would approve it, the committee would approve it, the NCI would approve it, and then what scope and what number and how many measures do we want to do and can we justify all the data we want to collect. Anyway, many, many steps, but eventually we did it, and we enrolled basically a little over 3,100 patients. It was a very large prospective study.
Tacey Ann Rosolowski, PhD:
What does SOAPP stand for?
Michael Fisch, MD:
Symptom Outcomes and Practice Patterns. So actually at least right now, if you go to www.ecogsoapp.com, that website is a website for the study that would describe for you the study, some of the data, the publications, the background, how you can get some of these data to plan your research. So that was actually another unique contribution of this study. We did this big study, but then how to disseminate and make this resource available not just to us but to everybody. It’s one thing to disseminate it by publishing, so we published a dozen papers or so, so far, from this study over time, and we are still publishing on it, because it’s a very large dataset, and it’s not just me and a few people, right? So you wait to see who’s got a question that the dataset might be able to inform, and they come up with hypothesis and then submit that for a secondary concept, and it gets approved and they deliver the data and they publish it. But anyway, the idea that a study would have its own website and would use that website to interact with others and data-share and disseminate, that was a unique element of the study as well, and that required another set of dialogue, some proposals, some other funding. And then, like anything else, the funding for the study runs out, then the funding for the website runs out, and then the study, the data are still there, the website’s still there. The money’s gone, and you’re still trying to manage these legacy things. So all that has a certain life, but the SOAPP study is a landmark study, kind of like the Predict study.
Fisch, Michael J. MD, MPH and Rosolowski, Tacey A. PhD, "Chapter 21: A Landmark Study on Chemotherapy and Depression" (2015). Interview Chapters. 844.
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