Chapter 15: The Community Clinical Oncology Program (CCOP); Finances, Organization of Research, Some Examples
Dr. Fisch begins this segment by noting that he began looking for experts to begin developing the new focus of the CCOP. He explains why MD Anderson physicians need community based patients.
He explains finances: the program pays for the infrastructure, not the drugs and other related costs. He discusses strategies researchers use to address this challenge. He gives an example of a trial run by Dr. Lorenzo Cohen comparing the impact of meditation versus relaxing music on patients’ inflammation cascade. He discusses how to convince community physicians of the value of such studies.
Dr. Fisch notes his role as facilitator and stresses the importance of being respectful of the research issues that behavioral scientists confront. He gives some examples.
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Michael Fisch, MD:
So then you start figuring out, well, who are the experts around here? And it’s not so much drug-oriented, but working with Palliative Care and Rehab, behavioral scientists, integrative medicine specialists, cancer pain people, anybody with these types of ideas. But the whole program was based around interventions, so it wasn’t for just descriptive studies, it wasn’t for health services research or cancer care delivery research or quality improvement things. It was more or less interventional research, and a lot of it was sort of empirical. So somebody might say, a rehab physician here, Dr. Gwo [phonetic] and others, working with Art Forman [phonetic], a neurologist, might say, “We think that alpha lipoic acid would be able to prevent the neuropathy, or nerve damage, due to Cisplatin-based chemotherapy, and here’s why we think that on some small observational bases and some theoretical bases. But it’s not proven, and we’d like to do a trial where we look at using alpha lipoic acid compared to placebo to prevent platinum-related neuropathy.” That would be an example, a neurologist, a rehab physician, an idea related to treatment. And then can we do that? That’s much easier to do in the community setting than it is to do here. The rehab specialists are not all seeing platinum-exposure patients. They’re just getting referred patients. So they can’t just wait in clinic for a flow of these people to come through into the trial. And none of them are in the setting where they can prevent. You know, the neurologist is getting referred people with neuropathy but is not seeing people at risk for neuropathy, so they can’t enroll patients under their own practice to address this question. They need help. So the neurologist and rehab physician would be very knowledgeable, could work together, could write a study, but would need an oncologist to execute the study, and would need a setting, probably of general oncology, where multiple reasons to use Cisplatin would be there across diseases, and then you could conduct the study. So that’s kind of a nice example of general oncology meets supportive care and supportive oncology, and in a cancer control type of study, having more to do with cancer control, meaning things that are not directly anti-disease, some aspect of care that’s not directly disease-focused. So, yeah, that’s an example. So that’s really where the program started to go, and then we started to not only work on—drug trials are tough because somebody has to pay for the drug. The program sort of pays for the infrastructure, the data management, the incentive to enroll patients, but they don’t pay for the intervention themselves. So if you want to give 150 people alpha lipoic acid and 150 people placebo, you’ve got to come up with a drug and you’ve got to come up with a placebo. Who’s going to make a placebo that looks the same? And then how are you going to distribute it to the sites? I mean, all these pieces of the puzzle are not funded, so you end up having to get other grants or work with companies that will help you do this, and generally speaking, if there’s not an FDA approval and a market for what they’re doing, then it can be hard to put these things together. So you can try, and we conducted the alpha lipoic acid trial with the help of a company. But in the end, the other thing you can do is start doing interventions that you don’t have to pay for, or you don’t have to pay for in such a discrete way. You don’t have so much trouble distributing it. So it might be like a mindfulness relaxation technique versus relaxing music as a control to prevent chemotherapy-associated symptoms and ameliorate those.
Tacey Ann Rosolowski, PhD:
Was that a real study?
Michael Fisch, MD:
It’s a real study.
Tacey Ann Rosolowski, PhD:
What were the results of that study?
Michael Fisch, MD:
Well, this study took a number of years. It’s now complete and being analyzed, so I don’t have the final punch line quite yet. This was a study led by Lorenzo Cohen, who’s a fabulous researcher in integrative medicine, a professor whose background is behavioral science, and really a world leader in integrative medicine, collaborating with a physician in Toronto whose name is John Hunter [phonetic]. He was a psychiatrist and just a terrific thinker and a great partner. So a psychiatrist in Toronto and a Ph.D. behavioral scientist integrative medicine guru here, working with community practices whose patients experience a potpourri of symptoms during chemotherapy and thinking that a mind-body intervention could work for various reasons related to this sort of ideas about the inflammatory cascade and the mind-body relationships that are involved, and the neurohumoral access, you know, the connection between number of hormones and inflammation. So quite a nice body of science around that. That study would involve empirically, like did the mindfulness relaxation group or the relaxing music group have better experience, but also collecting biological correlates to say did the slope of cortisol change seem more normal and physiologic in the group that got the intervention and was more blunted and abnormal in the group that didn’t respond, the control group that maybe wouldn’t respond as well. So to do that sort of thing, first you have to explain to the community oncologists why this makes sense and what the biology and the background science is, and then you have to understand their workflow, like how would you do this, who’s going to teach them mindfulness relaxation, where do people get chemotherapy, where is this intervention going to take place, how can you do it in a HIPPA-compliant manner, how can you do it without increasing the amount of chair time that they spend, because chair time is money in your practice as you try to run it efficiently. So, all kinds of logistical issues of trying to conduct the research. Then it’s not like these days where you might get on the web and try to get some interaction, but this particular study involved training the specific people who would be at that practice, because it’s to deliver the intervention. So it might be if you were a nurse and you were working in Spartanburg, South Carolina, that we would train you about this intervention so you understood the basis of it, but then you would record a CD of your voice doing the intervention so that the patient would learn it from you but then would have a CD, would hear your voice reinforcing the intervention. So it was tailored, and that’s an element of the trial. But, anyway, all this stuff means travel time for the guys from Toronto to do the training, for making the CDs, and then sometimes staff turnover. What if the person you trained in Spartanburg got a new job? Does the study end there? Are you going to train more than one of them? Are you going to bring them back and make another recording? You’d have to have different sessions. So the logistics of doing any of this stuff is tricky. But, again, in my role, I’m a facilitator of this type of research, to know what we need, to know what kind of expertise is involved, and very respectful of the fact that behavioral scientists, they encounter all kinds of research issues both at the conceptual level, how to write them, how to get them approved by the review committees to be conducted, because we don’t get to just decide what we’re going to do and do it. We decide what we want to do, and since this grant program is a cooperative agreement between us and the NCI, the NCI reviews and approves whether their grant funds will be used for what kind of research. So you need behavioral scientists to have the ideas, to sell those ideas, to make sure they’re tight and rigorous enough, and to have the professionalization to work through all the various pieces of the execution of these projects and then ultimately, also, the analysis of these things. How do you analyze these sort of data? These are things that are often tricky to find the right statistician. You can’t just say, well, data analysis is a statistician issue. You need the right kind of statisticians interacting with, many times, behavioral scientists or whatever kind of scientists you’re talking about who bring their perspective to that data, and the analysis is sort of a team effort in its own right. It’s not just a commodity that you hand over to a statistician. The statisticians are actually involved in the construction of the project and often the execution of the project as they kind of learn what’s going on with the data. So when done properly, that’s very carefully coordinated over time. So, behavioral science center, it could be exercise. We did mindfulness relaxation versus relaxing music. We’ve done an exercise intervention during the time that people are getting chemotherapy for colorectal cancer versus a control which was not as rigorous and that sort of thing.
Fisch, Michael J. MD, MPH and Rosolowski, Tacey A. PhD, "Chapter 15: The Community Clinical Oncology Program (CCOP); Finances, Organization of Research, Some Examples" (2015). Interview Chapters. 838.
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