Author: Carlson LE1, Zelinski EL2, Speca M2, Balneaves LG3, Jones JM4, Mina DS4, 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
1Department of Oncology, University of Calgary, Calgary, AB, Canada; Cancer Control Board, Alberta Health Services, AB, Canada. Electronic address: firstname.lastname@example.org.
2Department of Oncology, University of Calgary, Calgary, AB, Canada; Cancer Control Board, Alberta Health Services, AB, Canada.
3College of Nursing, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, MB, Canada.
4Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.
5Osher Center for Integrative Medicine, Harvard Medical School, Brigham and Women's Hospital, Boston, MA, USA.
6Department of Psychology, University of Calgary, Calgary, AB, Canada.
7Centre for Advancement of Health, Alberta Health Services, AB, Canada.
8School of Public Policy, University of Calgary, Calgary, AB, Canada.
9Department of Immunology, University of Calgary, Calgary, AB, Canada.
10Department of Biochemistry and Molecular Biology, University of Calgary, Calgary, AB, Canada.
11Department of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.
12Department of Oncology, University of Calgary, Calgary, AB, Canada.
13Department of Anesthesia, University of Toronto, ON, Canada.
14Department of Athletics and Recreation, McMaster University, Hamilton, ON, Canada.
15Department of Oncology, McMaster University, Hamilton, ON, Canada; Department of Medicine, McMaster University, Hamilton, ON, Canada.
16Department of Pediatrics, Faculty of Medicine and Dentistry, Integrative Health Institute, University of Alberta, Edmonton, AB, Canada.
Conference/Journal: Contemp Clin Trials.
Date published: 2017 May 30
Other: Pages: S1551-7144(17)30015-0 , Special Notes: doi: 10.1016/j.cct.2017.05.015. [Epub ahead of print] , Word Count: 272
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. Published by Elsevier Inc.
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