The MATCH Study: Mindfulness And Tai Chi for Cancer Health

Linda E. Carlson600 enrolled

Overview

Background: As more people survive cancer, the importance of research on effective interventions for improving quality of life (QOL) amongst survivors is growing. Two interventions with a substantial evidence-base are Mindfulness-Based Cancer Recovery (MBCR) and Tai chi/Qigong (TCQ). However, these interventions have never been directly compared. Objectives: (1) To compare MBCR and TCQ to each other and a waitlist control condition using an innovative, randomized, preference-based comparative effectiveness trial (CET) design that takes into account potential moderating factors that might predict differential response. (2) To investigate the impacts of MBCR and TCQ on a range of biological outcomes including immune processes, blood pressure, heart rate variability, stress hormones, cellular aging, and gene expression. Methods: The study design is a preference-based multi-site randomized CET incorporating two Canadian sites (Calgary, AB and Toronto, ON). Participants (N total = 600). Participants with a preference for either MBCR or TCQ will get their preferred intervention; while those without a preference will be randomized into either of the two interventions. Within the preference and non-preference groups, participants will also be randomized into immediate intervention groups or a wait-list control. Outcome measures to be assessed pre- and post-intervention and at 6-month follow up include psychological outcomes (mood, stress, mindfulness, spirituality, post-traumatic growth), QOL, symptoms (fatigue, sleep), physical function (strength, endurance), and exploratory analyses of biomarkers (cortisol slopes, cytokines, blood pressure/heart rate variability, telomere length, gene expression), and health economic measures. Hypotheses: The investigators theorize that both MBCR and TCQ will improve outcomes amongst survivors relative to treatment as usual, particularly if patients have a strong preference for a particular intervention. Specifically, the investigators hypothesize that MBCR may be superior to TCQ on measures related to stress and mood. Conversely, TCQ may be superior to MBCR in improvement of physical and functional measures.

Background While there is ample research documenting the problems people diagnosed with cancer face, including high levels of distress, anxiety, depression and symptoms such as fatigue, pain and sleep disturbance, there is also a limited but growing body of evidence supporting the efficacy of a range of mind-body therapies (MBTs) in alleviating these and other symptoms. The investigators have chosen to focus on comparing MBCR and TCQ because both have level 1 evidence in cancer care, and both have shown potential to affect important biomarkers and clinical outcomes. Both interventions are similarly rooted in meditative practice, but MBCR has greater emphasis on mental practice, while TCQ is more emphatically a body movement-based practice. The investigators also anticipate that many patients will have a preference for one or the other. Evidence for the efficacy of each will be briefly reviewed followed by details of study design and methods. Mindfulness-Based Cancer Recovery (MBCR) Through an ongoing program of research the investigators adapted a group intervention based on intensive training in mindfulness meditation (Mindfulness-Based Stress Reduction; MBSR) specifically for people with cancer, and called it Mindfulness-Based Cancer Recovery (MBCR), acknowledging the roots of the program but also that its form and content is somewhat different, and focused primarily on the challenges faced by people living with cancer. It is an 8-week program consisting of weekly group meetings of 1.5 to 2 hours, shortened from traditional MBSR based on practical logistical concerns and the needs of the study population. Home practice of 45 minutes per day (15 min yoga; 30 min meditation) is prescribed. As the weeks progress, different forms of meditation are introduced, beginning with a body scan sensory awareness experience, progressing to sitting and walking meditations. Gentle Hatha yoga is incorporated throughout, as a form of moving meditation. Didactic instruction as well as group discussion and reflection, problem solving and skillful inquiry are commonly applied teaching tools. Since 1998, the investigators have tested its efficacy in a wide range of studies and groups of people with cancer, beginning with psychological outcomes including stress symptoms, mood disturbance including anxiety, anger and depression, then expanding in scope and scale to assess effects on sleep disturbance and fatigue. The investigators also examined positive outcomes including post-traumatic growth, spirituality and benefit finding. To assess potential biological mechanisms of change, the investigators examined the effects of the program on biomarkers including blood pressure, inflammatory cytokines, stress hormones and most recently telomere length using increasingly sophisticated study designs, showing benefit across all of these measures. The investigators work on MBCR for cancer patients and survivors has spanned the spectrum of research from basic mechanistic research to clinical trials and implementation science. Others, as well, have studied MBSR with cancer patients, and several reviews and meta-analyses summarize its benefits across outcomes of anxiety, stress, mood disturbance and quality of life. Tai Chi/Qigong (TCQ) Work has also been done evaluating the efficacy of tai-chi and qigong in cancer care, and reviews are now available for both. Tai chi is a shortened name for Tai Chi Ch'uan, a form of martial art from traditional Chinese medicine. It involves a series of slow specific movements or "forms" done in a meditative fashion. It is purported that focusing the mind solely on the movements of the form helps to bring about a state of mental calm and clarity. The practice itself has been separated from its martial arts roots and is widely taught as a health behavior practice and exercise. In cancer care, a review of seven controlled trials in breast cancer patients concluded that while tai chi helped to improve psychological and physical health measures compared to usual care, compared to other active interventions it may not be superior. Overall in elderly samples, a larger body of research supports its efficacy for improving balance and preventing falls and improving overall psychological well-being, but larger studies with better designs are needed. Similarly, a growing body of research suggests efficacy of qigong, a practice of aligning breath, movement, and awareness for exercise, healing, and meditation. Qigong is traditionally viewed as a practice to cultivate and balance qi (chi) or "intrinsic life energy". Qigong exercises generally have three components: a posture (whether moving or stationary), breathing techniques, and mental focus on guiding qi through the body. A review of the literature including Chinese and Korean databases found 23 studies in cancer care. The most consistent benefits were seen on immune system function (reduced inflammation), improved mood, quality of life, and fatigue. As is the case with tai chi studies, randomized controlled trials with larger samples sizes are necessary to generalize findings. The study protocol incorporates simple Tai Chi elements within a healing framework stemming from Qigong principles. For that reason the investigators call it Tai Chi/Qigong (TCQ).

Interventions

Mindfulness Based Cancer Recovery (MBCR)BEHAVIORAL

Mindfulness-Based Cancer Recovery (MBCR) is a standardized group program which focuses primarily on the challenges faced by people living with cancer. It is an 8-week program consisting of weekly group meetings of 1.5 to 2 hours. Home practice of 45 minutes per day (15 min yoga; 30 min meditation) is prescribed. As the weeks progress, different forms of meditation are introduced, beginning with a body scan sensory awareness experience, progressing to sitting and walking meditations. Gentle Hatha yoga is incorporated throughout, as a form of moving meditation. Didactic instruction as well as group discussion and reflection, problem solving and skillful inquiry are commonly applied teaching tools.

Tai Chi/Qigong (TCQ) for Cancer PatientsBEHAVIORAL

TCQ involves a series of slow specific movements or "forms" done in a meditative fashion. It is purported that focusing the mind solely on the movements of the form helps to bring about a state of mental calm and clarity. The practice itself has been separated from its martial arts roots and is widely taught as a health behavior practice and exercise. Qigong exercises generally have three components: a posture (whether moving or stationary), breathing techniques, and mental focus on guiding qi through the body. Our program, developed specifically for a cancer patient population, incorporates simple Tai Chi elements within a healing framework stemming from Qigong principles.

Outcomes

Primary Outcomes

Profile of Mood States - Total Mood Disturbance (POMS-TMD)

The POMS-TMD is the overall score of mental disturbance. Linear mixed modelling will be used to assess change over time.