NCT02801123

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

August 29, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

4.3 years

First QC Date

May 31, 2016

Last Update Submit

March 21, 2023

Conditions

Keywords

Complimentary Cancer TherapiesPsychosocial OncologyBehavioural MedicineMindfulness Based Cancer RecoveryTai ChiQigongMindfulness-Based Stress ReductionYogaPreference-based trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion

Secondary Outcomes (19)

  • Pittsburgh Sleep Quality Index

    pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion

  • Brief Pain Inventory

    pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion

  • The Functional Assessment of Cancer Therapy - Fatigue (FACT-F)

    pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion

  • POMS - Subscale scores (6)

    pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion

  • Symptoms of Stress Inventory (C-SOSI-32)

    pre-intervention, within 3 weeks of completion of the intervention, 6-month follow up from intervention completion

  • +14 more secondary outcomes

Study Arms (8)

Preference: MBCR (im)

EXPERIMENTAL

Individuals with a preference for 'Mindfulness-Based Cancer Recovery (MBCR)' randomized to immediate treatment

Behavioral: Mindfulness Based Cancer Recovery (MBCR)

Preference: TCQ (im)

EXPERIMENTAL

Individuals with a preference for 'Tai Chi/Qigong (TCQ) for Cancer Patients' randomized to immediate treatment

Behavioral: Tai Chi/Qigong (TCQ) for Cancer Patients

Preference: MBCR (wl)

ACTIVE COMPARATOR

Individuals with a preference for 'Mindfulness-Based Cancer Recovery (MBCR)' randomized to waitlist

Behavioral: Mindfulness Based Cancer Recovery (MBCR)

Preference: TCQ (wl)

ACTIVE COMPARATOR

Individuals with a preference for 'Tai Chi/Qigong (TCQ) for Cancer Patients' randomized to waitlist

Behavioral: Tai Chi/Qigong (TCQ) for Cancer Patients

No Preference: MBCR (im)

EXPERIMENTAL

Individuals with no preference randomized to 'Mindfulness-Based Cancer Recovery (MBCR)' - immediate

Behavioral: Mindfulness Based Cancer Recovery (MBCR)

No Preference: TCQ (im)

EXPERIMENTAL

Individuals with no preference randomized to 'Tai Chi/Qigong (TCQ) for Cancer Patients' - immediate

Behavioral: Tai Chi/Qigong (TCQ) for Cancer Patients

No Preference: MBCR (wl)

ACTIVE COMPARATOR

Individuals with no preference randomized to 'Mindfulness-Based Cancer Recovery (MBCR)' - waitlist

Behavioral: Mindfulness Based Cancer Recovery (MBCR)

No Preference: TCQ (wl)

ACTIVE COMPARATOR

Individuals with no preference randomized to 'Tai Chi/Qigong (TCQ) for Cancer Patients' - waitlist

Behavioral: Tai Chi/Qigong (TCQ) for Cancer Patients

Interventions

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.

No Preference: MBCR (im)No Preference: MBCR (wl)Preference: MBCR (im)Preference: MBCR (wl)

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.

No Preference: TCQ (im)No Preference: TCQ (wl)Preference: TCQ (im)Preference: TCQ (wl)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women over the age of 18
  • Diagnosed with any type of cancer (stage I-III) excluding head, neck, or brain
  • Experiencing significant distress (4 or greater on the Distress Thermometer)
  • Able to attend MBCR or TCQ classes at scheduled times
  • Sufficient functional capacity to participate in intervention groups (as judged by PAR-Q questionnaire, study staff, participant and participant's physician)
  • Ability to speak and write English sufficiently to complete questionnaires and participate in groups.

You may not qualify if:

  • 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).
  • Cognitive impairment that would interfere with completing questionnaires or the intervention.
  • Suffering from current Major Depressive Disorder, Bipolar Disorder or other psychiatric disorder that would interfere with the ability to participate.
  • Currently engages in meditation or tai chi one or more times per week
  • Previous participation in MBCR program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Psychosocial Oncology, Cancer Control Alberta

Calgary, Alberta, T2N 3C1, Canada

Location

ELLICSR Centre, Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Location

Related Publications (1)

  • Carlson LE, Jones JM, Oberoi D, Piedalue KA, Wayne PM, Santa Mina D, Lawal OA, Speca M. Mindfulness and Tai Chi for Cancer Health (MATCH) Study: Primary Outcomes of a Preference-Based Multisite Randomized Comparative Effectiveness Trial. J Clin Oncol. 2025 Jul 20;43(21):2372-2386. doi: 10.1200/JCO-24-02540. Epub 2025 Jun 12.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Linda E Carlson, PhD

    University of Calgary, Cancer Control Alberta, Alberta Health Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Department of Oncology

Study Record Dates

First Submitted

May 31, 2016

First Posted

June 15, 2016

Study Start

August 29, 2016

Primary Completion

December 31, 2020

Study Completion

December 31, 2023

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations