Protocol for the MATCH study (Mindfulness and Tai Chi for cancer health): A preference-based multi-site randomized comparative effectiveness trial (CET) of Mindfulness-Based Cancer Recovery (MBCR) vs. Tai Chi/Qigong (TCQ) for cancer survivors.

Contemp Clin Trials. 2017 May 30;59:64-76. doi: 10.1016/j.cct.2017.05.015. [Epub ahead of print]

Carlson LE¹, Zelinski EL², Speca M², Balneaves LG³, Jones JM⁴, Santa Mina D⁴, Wayne PM⁵, Campbell TS⁶, Giese-Davis J², Faris P⁷, Zwicker J⁸, Patel K⁹, Beattie TL¹⁰, Cole S¹¹, Toivonen K⁶, Nation J¹², Peng P¹³, Thong B¹⁴, Wong R¹⁵, Vohra S¹⁶.

Author information

1

Department of Oncology, University of Calgary, Calgary, AB, Canada; Cancer Control Board, Alberta Health Services, AB, Canada. Electronic address: l.carlson@ucalgary.ca.

2

Department of Oncology, University of Calgary, Calgary, AB, Canada; Cancer Control Board, Alberta Health Services, AB, Canada.

3

College of Nursing, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada.

4

Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.

5

Osher Center for Integrative Medicine, Harvard Medical School, Brigham and Women's Hospital, Boston, MA, USA.

6

Department of Psychology, University of Calgary, Calgary, AB, Canada.

7

Centre for Advancement of Health, Alberta Health Services, AB, Canada.

8

School of Public Policy, University of Calgary, Calgary, AB, Canada.

9

Department of Immunology, University of Calgary, Calgary, AB, Canada.

10

Department of Biochemistry and Molecular Biology, University of Calgary, Calgary, AB, Canada.

11

Department of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.

12

Department of Oncology, University of Calgary, Calgary, AB, Canada.

13

Department of Anesthesia, University of Toronto, ON, Canada.

14

Department of Athletics and Recreation, McMaster University, Hamilton, ON, Canada.

15

Department of Oncology, McMaster University, Hamilton, ON, Canada; Department of Medicine, McMaster University, Hamilton, ON, Canada.

16

Department of Pediatrics, Faculty of Medicine and Dentistry, Integrative Health Institute, University of Alberta, Edmonton, AB, Canada.

Abstract

PURPOSE:

A growing number of cancer survivors suffer high levels of distress, depression and stress, as well as sleep disturbance, pain and fatigue. Two different mind-body interventions helpful for treating these problems are Mindfulness-Based Cancer Recovery (MBCR) and Tai Chi/Qigong (TCQ). However, while both interventions show efficacy compared to usual care, they have never been evaluated in the same study or directly compared. This study will be the first to incorporate innovative design features including patient choice while evaluating two interventions to treat distressed cancer survivors. It will also allow for secondary analyses of which program best targets specific symptoms in particular groups of survivors, based on preferences and baseline characteristics.

METHODS AND SIGNIFICANCE:

The design is a preference-based multi-site randomized comparative effectiveness trial. Participants (N=600) with a preference for either MBCR or TCQ will receive their preferred intervention; while those without a preference will be randomized into either intervention. Further, within the preference and non-preference groups, participants will be randomized into immediate intervention or wait-list control. Total mood disturbance on the Profile of mood states (POMS) post-intervention is the primary outcome. Other measures taken pre- and post-intervention and at 6-month follow-up include quality of life, psychological functioning, cancer-related symptoms and physical functioning. Exploratory analyses investigate biomarkers (cortisol, cytokines, blood pressure/Heart Rate Variability, telomere length, gene expression), which may uncover potentially important effects on key biological regulatory and antineoplastic functions. Health economic measures will determine potential savings to the health system.

Copyright © 2017 Elsevier Inc. All rights reserved.

KEYWORDS:

Biomarkers; Cancer survivors; Clinical trial; Exercise; Mindfulness; Mood disturbance; Preference trial; Qigong; Quality of life; Stress; Tai Chi; Yoga

PMID:

28576734

DOI:

10.1016/j.cct.2017.05.015