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MATCH Study: Breaking the clinical trials mold

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The MATCH Study: Mindfulness And Tai chi for Cancer Health. This innovative clinical trial conducted by the University of Calgary/Tom Baker Cancer Centre and the Princess Margaret Cancer Centre is now recruiting cancer survivors! As a participant you get to choose which treatment approach you want, or let us assign you to a group if you are equally interested in both. We will measure program effects on psychological, physical and biological outcomes including quality of life, mood, stress, balance, blood pressure, heart rate, immune function and more! Visit www.thematchstudy.ca for more details.

 

 

by Dr. Linda E. Carlson, Study Principal Investigator

 

The Match Study Methods

If you’ve been following these blog posts about the MATCH study, you’ll know that we are comparing group programs in Mindfulness-Based Cancer Recovery to Tai Chi/Qigong for distressed cancer survivors. That’s the overall study design, but there are some interesting ways we are setting up the study that are completely novel, and allow us to make very important comparisons once the study is done. First and foremost, unlike the norm in randomized trials, we are letting people choose the intervention they prefer, either mindfulness or tai chi. They get to take the group they want. While this only makes sense in a real-word setting where people make choices like this all the time, usually in scientific studies like this people don’t get to choose – the researchers tell them which program they get, like the flip of a coin. This can result in many people being assigned to a group they didn’t really want when they signed up for the study.

 

Imagine for a moment you sign up for a study with two interventions (say it’s a mindfulness group or a talk therapy support group). Likely you are really much more interested in one than the other, but what if you are assigned to take the one you’re not as keen on? Would that affect the way you respond to the program? I would think so. But this is rarely taken into account or even measured in traditional randomized controlled trials. So what we did in a previous study(1) was to ask the question: Does it matter if people are assigned to the group they most want? Specifically, will they benefit equally from a mindfulness group whether it’s what they wanted, or if it was their second choice? What we did was ask people at the beginning of a study which of three groups they were really hoping to get: mindfulness, the support group, or a one-day stress management seminar. But then they were randomized to one of the three, not taking into account their actual preference. In fact, about half of the people wanted the mindfulness group, another 20% wanted the support group, 15% wanted the one-day seminar and 15% had no real preference. When all was said and done, only about 30% of all participants got the group they initially wanted. When we then compared outcomes between that 30% who got the group they wanted (no matter which group it was) and those who did not, lo and behold, the people who got their preference improved more on some outcomes, like quality of life and stress symptoms.

 

What does this tell us? Well obviously that preference matters! It needs to be taken into account when we evaluate therapies in randomized trials or the results we find may not be due to the power of the therapy itself as much as the expectations and hopes a person takes into the program.

 

So in the MATCH study the first thing we do when people join up is ask them which group they are hoping to get, or if they are equally interested in both. If they have a preference, they get that group. If they don’t have a preference, then we randomly assign them. This way we can compare the outcomes of people in mindfulness who chose it to people in the same group who were assigned; similarly in tai chi/qigong we can compare those who wanted it specifically to those randomized to it. This will allow us to separate out, to a certain extent, the power of preference, or expectancy (or some might call it the placebo effect!). This is very exciting and a first for research into these therapies. We are just beginning to see what the distribution of preferences is across therapies and so far things are coming out pretty equally, which is great! We are now recruiting participants in both Calgary and Toronto, and need people who are interested in either group, and especially people willing to be randomized to either as well.

 

MATCH study breaks the clinical trials mold and allows patients to choose their intervention.

For more information visit our website: www.thematchstudy.ca

 

 

 


 

Reference

Carlson, L. E., R. Tamagawa, J. Stephen, R. Doll, P. Faris, D. Dirkse, and M. Speca. (2014). Tailoring Mind-Body Therapies to Individual Needs: Patients’ Program Preference and Psychological Traits as Moderators of the Effects of Mindfulness-Based Cancer Recovery and Supportive-Expressive Therapy in Distressed Breast Cancer Survivors. J Natl Cancer Inst Monogr (2014)2014 (50): 308-314.

 


 

 

 

lindacarlsonDr. Linda Carlson holds the Enbridge Research Chair in Psychosocial Oncology, is an Alberta Innovates-Health Solutions Health Scholar, Full Professor in Psychosocial Oncology in the Department of Oncology, Cumming School of Medicine at the University of Calgary, and Adjunct Professor in the Department of Psychology. She is the Director of Research and works as a Clinical Psychologist at the Department of Psychosocial Resources at the Tom Baker Cancer Centre.

Dr. Carlson’s research in Mindfulness-Based Cancer Recovery has been published in many high-impact journals and book chapters, and she published a patient manual in 2010 with Michael Speca entitled: Mindfulness-Based Cancer Recovery: A step-by-step MBSR approach to help you cope with treatment and reclaim your life, in addition to a professional training manual in 2009 with Shauna Shapiro entitled The Art and Science of Mindfulness: Integrating mindfulness into psychology and the helping professions. She has published over 150 research papers and book chapters in the area of psycho-oncology, been awarded several national and international reserach awards, holds several millions of dollars in grant funding and is regularly invited to present her work at international conferences.

 

 

 


 

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