Clinical trial NCT02801123: The MATCH Study: Mindfulness And Tai Chi for Cancer Health
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Keywords: Complimentary Cancer Therapies
Psychosocial Oncology
Behavioural Medicine
Mindfulness Based Cancer Recovery
Tai Chi
Qigong
Mindfulness-Based Stress Reduction
Yoga
Preference-based trial
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: University of Calgary
name: Alberta Health services
name: Tom Baker Cancer Centre
name: Princess Margaret Hospital, Canada
First posted: 2016-06-15
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

1. Men and women over the age of 18
2. Diagnosed with any type of cancer (stage I-III) excluding head, neck, or brain
3. Completed active treatment (i.e. surgery, chemotherapy, radiation therapy) at least 4 months previously (ongoing hormonal therapies, AIs, tamoxifen, herceptin are not exclusionary)
4. Experiencing significant distress (4 or greater on the Distress Thermometer)
5. Able to attend MBCR or TCQ classes at scheduled times
6. Sufficient functional capacity to participate in intervention groups (as judged by PAR-Q questionnaire, study staff, participant and participant's physician)
7. Ability to speak and write English sufficiently to complete questionnaires and participate in groups.

Exclusion Criteria:

1. Metastatic patients and those with ongoing chemotherapy (because ongoing therapy may impair biomarker profiles, and metastatic patients may not be stable enough to participate in the interventions and follow-up assessments).
2. Cognitive impairment that would interfere with completing questionnaires or the intervention.
3. Suffering from current Major Depressive Disorder, Bipolar Disorder or other psychiatric disorder that would interfere with the ability to participate.
4. Currently engages in meditation or tai chi one or more times per week
5. Previous participation in MBCR program.

Primary outcomes:
measure: Profile of Mood States - Total Mood Disturbance (POMS-TMD)
timeFrame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion
measure: Brief Pain Inventory
timeFrame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion
measure: The Functional Assessment of Cancer Therapy - Fatigue (FACT-F)
timeFrame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion
measure: POMS - Subscale scores (6)
timeFrame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion
measure: Symptoms of Stress Inventory (C-SOSI-32)
timeFrame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion
measure: The Functional Assessment of Cancer Therapy - General (FACT-G)
timeFrame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion
measure: The Functional Assessment of Chronic Illness therapy-Spiritual Well-being (FACIT-sp)
timeFrame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion
measure: Post-Traumatic Growth Inventory-Revised (PTGI-R)
timeFrame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion
measure: Average Diurnal Cortisol Slope
timeFrame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion
measure: Telomere length (TL) & Telomerase
timeFrame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion
measure: Heart Rate (HR)/Heart Rate Variability (HRV)
timeFrame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion
measure: Blood Pressure
timeFrame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion
measure: Timed Up and Go Test
timeFrame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion
measure: Maximal Walking Speed
timeFrame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion
measure: Maximum Grip Strength
timeFrame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion
measure: Single Leg Standing
timeFrame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion
measure: Cytokine Production
timeFrame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion
measure: Canadian Community Health Survey (CCHS)
timeFrame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion
measure: EQ-5D-5L
timeFrame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Psychosocial Oncology, Cancer Control Alberta
state: Alberta
city: Toronto
country: Canada
facility: ELLICSR Centre, Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: University of Calgary, Cancer Control Alberta, Alberta Health Services
name: Linda E Carlson, PhD
role: PRINCIPAL_INVESTIGATOR
References: