Official Title
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) in Cancer Survivors
Summary:
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.
Trial Description
Primary Outcome:
- Profile of Mood States - Total Mood Disturbance (POMS-TMD)
Secondary Outcome:
- Pittsburgh Sleep Quality Index
- Brief Pain Inventory
- The Functional Assessment of Cancer Therapy - Fatigue (FACT-F)
- POMS - Subscale scores (6)
- Symptoms of Stress Inventory (C-SOSI-32)
- The Functional Assessment of Cancer Therapy - General (FACT-G)
- The Functional Assessment of Chronic Illness therapy-Spiritual Well-being (FACIT-sp)
- Post-Traumatic Growth Inventory-Revised (PTGI-R)
- Average Diurnal Cortisol Slope
- Telomere length (TL) & Telomerase
- Heart Rate (HR)/Heart Rate Variability (HRV)
- Blood Pressure
- Timed Up and Go Test
- Maximal Walking Speed
- Maximum Grip Strength
- Single Leg Standing
- Cytokine Production
- Canadian Community Health Survey (CCHS)
- EQ-5D-5L
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 behaviour 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).
View this trial on ClinicalTrials.gov
