Effects of Meditative Movement (Qigong/Tai Chi Easy) on Fatigued Breast Cancer Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2020-12-30

Brief Summary

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The purpose of this study is to test whether Meditative Movement (based on a standardized and tested Qigong/Tai Chi Easy protocol) is more efficacious for improving fatigue and other symptoms in women after treatment for breast cancer than (a) a non-meditative "sham" Qigong active intervention and (b) an inactive education / support group.

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Detailed Description

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Patients with breast cancer often report fatigue and other associated symptoms that persist for months, even years, after treatment ends. In a recent pilot study of Qigong/Tai Chi Easy (QG/TCE, a low-intensity form of Meditative Movement), fatigued breast cancer survivors experienced greater improvements in fatigue (medium effect size, .56); compared to a "sham" Qigong control intervention (also low-intensity activity). Trends for improvement compared to control were found for sleep quality and depression. Recruitment for the single-site implementation was steady, and feasible. To build upon the promise of this pilot study, and to further test intervention components that may elucidate what aspects of the intervention have the most impact, a three-group, randomized trial will be undertaken to test effects of an 8-week QG/TCE intervention on fatigue and other symptoms at the end of 8 weeks, and 24 weeks post-intervention. 246 (attrition to 210) women who are 6 months to 10 years past treatment for Stage 0- III breast cancer, aged 45-75, and post-menopausal, will be randomized into one of three study arms. Two comparison groups will be used, an educational support (ES) group control and an active sham Qigong (SQG) group with movements that are similar to and with the same level of physical activity intensity as QG/TCE, but without the focus on the breath and meditative state. These treatments allow for separation of effects associated with gentle exercise alone (controlled in SQG) and education/social support alone without any exercise (controlled in ES) relative to the mind-body practice of QG/TCE, to distinguish unique effects of the meditative and breath foci. The study will be implemented in two sites in a large, metropolitan area, including one low-income hospital (and catchment neighborhood) with larger numbers of Latina survivors where our research team has extensive community connections and cultural experience implementing exercise and meditative movement programs. Psychometrics and biomarkers related to symptoms before and after the interventions will be examined to further our understanding of the mechanisms associated with effects of QG/TCE, as distinct from ES and SQG.

Conditions

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Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Qigong/Tai Chi Easy

The Qigong/Tai Chi Easy (QG/TCE) intervention has been standardized, manualized, and has a formal training program for instructors from the Institute of Integral Qigong and Tai Chi (IIQTC).

Group Type EXPERIMENTAL

Qigong/Tai Chi Easy

Intervention Type OTHER

Classes will be at two different times of day (to accommodate working and non-working participants). Participants will attend one 60 minute class per week for the 8 weeks, with a recommended home practice time of 2 1/2 hours each week.

Sham Qigong

This active control group uses a gentle movement intervention, with similar types of movements with the same energy expenditure, but without the meditative states and breath focus as QG/TCE (validated in the pilot study using the Meditative Movement Inventory).

Group Type SHAM_COMPARATOR

Sham Qigong

Intervention Type OTHER

Classes will be at two different times of day (to accommodate working and non-working participants). Participants will attend one 60 minute class per week for the 8 weeks, with a recommended home practice time of 2 1/2 hours each week.

Educational Support

The Recovery Support Group will consist of a classroom-style intervention, designed to educate, engage interaction, and maintain participation and attention over 8 weeks. This group will include readings/discussions specific to breast cancer, and social interaction facilitation.

Group Type ACTIVE_COMPARATOR

Educational Support

Intervention Type OTHER

Class times and at-home readings correspond to dose set for the QG/TCE and SQG class times and home practice. Participants will attend one 60-minute class per week for the 8 weeks, with a recommended home practice time (reading, workbook completion) of 2 1/2 hours each week.

Interventions

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Qigong/Tai Chi Easy

Classes will be at two different times of day (to accommodate working and non-working participants). Participants will attend one 60 minute class per week for the 8 weeks, with a recommended home practice time of 2 1/2 hours each week.

Intervention Type OTHER

Sham Qigong

Classes will be at two different times of day (to accommodate working and non-working participants). Participants will attend one 60 minute class per week for the 8 weeks, with a recommended home practice time of 2 1/2 hours each week.

Intervention Type OTHER

Educational Support

Class times and at-home readings correspond to dose set for the QG/TCE and SQG class times and home practice. Participants will attend one 60-minute class per week for the 8 weeks, with a recommended home practice time (reading, workbook completion) of 2 1/2 hours each week.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with breast cancer, stage 0-III
* Between 6 months and 10 years past primary treatment
* Post-menopausal
* Experiencing fatigue (scoring \< 75 on "Vitality" scale of Short Form (SF)-36)
* English-speaking or Spanish-speaking

Exclusion Criteria

* Women who are unable to stand for 10-minute segments
* Women who have had substantial experience with mind-body practices that blend movement with mindfulness/breathing techniques, such as Yoga, Tai Chi, or Qigong
* Women who work night shifts (fatigue-related factor)
* Restless leg syndrome (fatigue-related factor)
* Hypothyroidism (fatigue-related factor)
* Currently diagnosed with anemia (fatigue-related factor)
* Uncontrolled diabetes (fatigue-related factor)
* Major severe clinical depression (fatigue-related factor)
* Use of antihistamine, cyclosporins, corticosteroids, sleeping aids
* Regular use of alcohol (more than 2 drinks per day)

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes