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The MATCH Study: Mindfulness And Tai Chi for Cancer Health (MATCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02801123
Recruitment Status : Recruiting
First Posted : June 15, 2016
Last Update Posted : March 18, 2019
Sponsor:
Collaborators:
University of Calgary
Alberta Health Services
Tom Baker Cancer Centre
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
Linda E. Carlson, University of Calgary

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.


Condition or disease Intervention/treatment Phase
Cancer Behavioral: Mindfulness Based Cancer Recovery (MBCR) Behavioral: Tai Chi/Qigong (TCQ) for Cancer Patients Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : August 29, 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Preference: MBCR (im)
Individuals with a preference for 'Mindfulness-Based Cancer Recovery (MBCR)' randomized to immediate treatment
Behavioral: Mindfulness Based Cancer Recovery (MBCR)
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.

Experimental: Preference: TCQ (im)
Individuals with a preference for 'Tai Chi/Qigong (TCQ) for Cancer Patients' randomized to immediate treatment
Behavioral: Tai Chi/Qigong (TCQ) for Cancer Patients
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.

Active Comparator: Preference: MBCR (wl)
Individuals with a preference for 'Mindfulness-Based Cancer Recovery (MBCR)' randomized to waitlist
Behavioral: Mindfulness Based Cancer Recovery (MBCR)
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.

Active Comparator: Preference: TCQ (wl)
Individuals with a preference for 'Tai Chi/Qigong (TCQ) for Cancer Patients' randomized to waitlist
Behavioral: Tai Chi/Qigong (TCQ) for Cancer Patients
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.

Experimental: No Preference: MBCR (im)
Individuals with no preference randomized to 'Mindfulness-Based Cancer Recovery (MBCR)' - immediate
Behavioral: Mindfulness Based Cancer Recovery (MBCR)
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.

Experimental: No Preference: TCQ (im)
Individuals with no preference randomized to 'Tai Chi/Qigong (TCQ) for Cancer Patients' - immediate
Behavioral: Tai Chi/Qigong (TCQ) for Cancer Patients
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.

Active Comparator: No Preference: MBCR (wl)
Individuals with no preference randomized to 'Mindfulness-Based Cancer Recovery (MBCR)' - waitlist
Behavioral: Mindfulness Based Cancer Recovery (MBCR)
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.

Active Comparator: No Preference: TCQ (wl)
Individuals with no preference randomized to 'Tai Chi/Qigong (TCQ) for Cancer Patients' - waitlist
Behavioral: Tai Chi/Qigong (TCQ) for Cancer Patients
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.




Primary Outcome Measures :
  1. Profile of Mood States - Total Mood Disturbance (POMS-TMD) [ Time Frame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion ]
    The POMS-TMD is the overall score of mental disturbance. Linear mixed modelling will be used to assess change over time.


Secondary Outcome Measures :
  1. Pittsburgh Sleep Quality Index [ Time Frame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion ]
    Several components of sleep quality are assessed including subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, sleep medication, and daytime dysfunction. Higher scores on the PSQI indicate worse sleep quality. Linear mixed modelling will be used to assess change over time.

  2. Brief Pain Inventory [ Time Frame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion ]
    The BPI allows participants to rate their pain along dimensions of pain severity and how much their pain interferes with daily experiences and functioning. Linear mixed modelling will be used to assess change over time.

  3. The Functional Assessment of Cancer Therapy - Fatigue (FACT-F) [ Time Frame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion ]
    The FACT-f allows participants to report how fatigue impacts function along the dimensions of physical well-being, social/family well-being, emotional-wellbeing, functional well-being, and fatigue. Linear mixed modelling will be used to assess change over time.

  4. POMS - Subscale scores (6) [ Time Frame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion ]
    The Profile of Mood States (POMS): Anxiety, Depression, Anger, Vigor, Fatigue and Confusion, which will be summed to generate a Total Mood Disturbance (TMD) score (primary outcome). The POMS has been widely used in clinical populations, including cancer patients. We will examine each of the subscales as well to determine the relative magnitude of changes. Linear mixed modelling will be used to assess change over time.

  5. Symptoms of Stress Inventory (C-SOSI-32) [ Time Frame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion ]
    Measures physical, psychological and behavioural responses to stressful situations. There are eight subscales entitled Depression, Anger, Muscle Tension, Sympathetic Arousal, Cardiopulmonary Arousal, Cognitive Disorganization, Neurological/GI and Upper Respiratory. A Total Stress Symptom score will be calculated by summing all the items. Linear mixed modelling will be used to assess change over time.

  6. The Functional Assessment of Cancer Therapy - General (FACT-G) [ Time Frame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion ]
    A general cancer quality of life measure including subscales for Physical Well-Being, Social Well-Being, Emotional Well-Being, Functional Well-Being and a Breast Cancer Symptom subscale, as well as the Total QL score will be used to assess overall quality of life. Linear mixed modelling will be used to assess change over time.

  7. The Functional Assessment of Chronic Illness therapy-Spiritual Well-being (FACIT-sp) [ Time Frame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion ]
    A 12-item questionnaire designed for people with cancer or other chronic illnesses. Subscales include Meaning, Peace and Faith, but can be summed to a Total Score. Linear mixed modelling will be used to assess change over time.

  8. Post-Traumatic Growth Inventory-Revised (PTGI-R) [ Time Frame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion ]
    Measures an individual's perception of positive changes following a traumatic life experience. Subscales include Relating to Others, New Possibilities, Personal Strength, Spiritual Change and Appreciation of Life, which are summed to form the Total Score. Linear mixed modelling will be used to assess change over time.

  9. Average Diurnal Cortisol Slope [ Time Frame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion ]
    Measure of adrenal function and stress hormones. At each assessment, saliva will be collected 4 times across the day (waking, 12:00, 17:00 and bedtime) over 3 days so that circadian fluctuations in salivary cortisol can be assessed through the calculation of an average diurnal slope of the line. Abnormal slopes are associated with disease stages and cancer progression. Abnormal slopes associated with disease stages and cancer progression. Linear mixed modelling will be used to assess changes in slopes over time.

  10. Telomere length (TL) & Telomerase [ Time Frame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion ]
    TL is a marker of cell aging associated with cancer risk and disease progression. TL will be measured using quantitative real-time polymerase chain reaction (qPCR) in triplicate. A T/S ratio is calculated that compares the TL in cells to a pooled reference sample. Linear mixed modelling will be used to assess change over time.

  11. Heart Rate (HR)/Heart Rate Variability (HRV) [ Time Frame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion ]
    HRV is a measure of the degree of variability between heart beats which reflects parasympathetic influence on the cardiac pacemaker by way of the tenth cranial nerve. Both low HRV and higher heart rate are predictors of shorter survival in metastatic breast cancer and are risk factors for cardiovascular disease. Linear mixed modelling will be used to assess change over time.

  12. Blood Pressure [ Time Frame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion ]
    Elevated BP is a risk factor for cardiovascular disease; many forms of chemotherapy and RT to the chest wall can damage the heart muscle and make cancer patients more vulnerable to heart disease after cancer treatment. Therefore it's important to monitor cardiovascular risk factors. Linear mixed modelling will be used to assess change over time.

  13. Timed Up and Go Test [ Time Frame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion ]
    Subjects are given verbal instruction to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. The average time (sec) of 3 trials will be recorded. Linear mixed modelling will be used to assess change over time.

  14. Maximal Walking Speed [ Time Frame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion ]
    Participants walk in a straight line as fast as possible, without running, on a premeasured 11 meter course. The time taken to walk 5 meters, from the 3 meter to 8 meter mark is used to calculate maximal walking speed (meters/second). Linear mixed modelling will be used to assess change over time.

  15. Maximum Grip Strength [ Time Frame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion ]
    The dominant hand will be measured using a hand-grip dynamometer. Measurements are recorded to the nearest 0.5 kg, repeated three times and averaged. Linear mixed modelling will be used to assess change over time.

  16. Single Leg Standing [ Time Frame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion ]
    Three 30 sec trials are completed for eyes-open and eyes-closed conditions, and the greatest duration (sec) for each condition is used for analysis. Linear mixed modelling will be used to assess change over time.

  17. Cytokine Production [ Time Frame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion ]
    Luminex multiplex assays, basic 48 cytokines (includes inflammatory and regulatory cytokines and chemokines) A range of different cytokines including TNF-alpha, IFN-gamma, IL-1, IL-4, IL-6, IL-10, IL-12, which have a variety of important inflammatory and anti-inflammatory functions in cancer will be examined. Linear mixed modelling will be used to assess change over time.

  18. Canadian Community Health Survey (CCHS) [ Time Frame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion ]
    Assesses the impacts of these interventions on health care costs and utilization.

  19. EQ-5D-5L [ Time Frame: pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion ]
    Evaluates the impact of the intervention on health and other medical interventions across time.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801123


Contacts
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Contact: Devesh Oberoi, PhD 403-698-8139 devesh.oberoi@albertahealthservices.ca
Contact: Marissa MacKenzie 403-355-3207 Marissa.MacKenzie@albertahealthservices.ca

Locations
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Canada, Alberta
Psychosocial Oncology, Cancer Control Alberta Recruiting
Calgary, Alberta, Canada, T2N 3C1
Contact: Erin L Zelinski, PhD    403-698-8139    erin.zelinski@albertahealthservices.ca   
Contact: Marissa McKenzie    403-355-3207    Marissa.MacKenzie@albertahealthservices.ca   
Principal Investigator: Linda E Carlson, PhD         
Canada, Ontario
ELLICSR Centre, Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada
Contact: Jennifer Jones, PhD       jennifer.jones@uhn.ca   
Contact: Daniel SantaMina       daniel.santamina@uhn.ca   
Principal Investigator: Jennifer Jones, PhD         
Sub-Investigator: Daniel SantaMina         
Sponsors and Collaborators
Linda E. Carlson
University of Calgary
Alberta Health Services
Tom Baker Cancer Centre
Princess Margaret Hospital, Canada
Investigators
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Principal Investigator: Linda E Carlson, PhD University of Calgary, Cancer Control Alberta, Alberta Health Services

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Responsible Party: Linda E. Carlson, Professor, Department of Oncology, University of Calgary
ClinicalTrials.gov Identifier: NCT02801123     History of Changes
Other Study ID Numbers: HREBA-CC-16-0246
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Linda E. Carlson, University of Calgary:
Complimentary Cancer Therapies
Psychosocial Oncology
Behavioural Medicine
Mindfulness Based Cancer Recovery
Tai Chi
Qigong
Mindfulness-Based Stress Reduction
Yoga
Preference-based trial