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

Study Overview
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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.

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.

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

Conditions
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Fatigue

Intervention / Treatment
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* Other: Qigong/Tai Chi Easy
* Other: Sham Qigong
* Other: Educational Support


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Qigong/Tai Chi Easy<br>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). | Other: Qigong/Tai Chi Easy<br>* 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.<br>|
| Sham Comparator: Sham Qigong<br>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). | Other: Sham Qigong<br>* 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.<br>|
| Active Comparator: Educational Support<br>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. | Other: Educational Support<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Symptom Inventory | Fatigue | Change from baseline fatigue to fatigue at 8 weeks and fatigue at 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profile of Mood States Short Form (POMS-SF) | Anxiety and depression | Change from baseline anxiety and depression to anxiety and depression at 8 weeks and anxiety and depression at 6 months. | 
| Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG) | Cognitive function | Change from baseline cognitive function to cognitive function at 8 weeks and cognitive function at 6 months. | 
| Pittsburgh Sleep Quality Index (PSQI) | Sleep quality | Change from baseline sleep quality to sleep quality at 8 weeks and sleep quality at 6 months | 
| Women's Health Initiative Brief Physical Activity Questionnaire (WHI-BPAQ) | Physical activity | Change from baseline physical activity (PA) to PA at 8 weeks and PA at 6 months | 
| Venipuncture for serum using MILLIPLEX MAP Human Cytokine/Chemokine Magnetic Bead Panel kits | Inflammatory biomarkers (IL-1β, IL-6,TNF-α; IFN-γ) | Change from baseline Inflammatory biomarkers (IL-1β, IL-6,TNF-α; IFN-γ) to Inflammatory biomarkers at 8 weeks | 
| Diurnal salivary samples (enzyme assay) | Salivary cortisol | Change from baseline salivary cortisol to salivary cortisol at 8 weeks | 
| ActiGraph GT3X activity monitor | Objective measurement of physical activity | Change from baseline objective physical activity to objective physical activity at 8 weeks and objective physical activity at 6 months | 
| ActiGraph GT3X activity monitor | Objective measurement of sleep quality | Change from baseline objective sleep quality to objective sleep quality at 8 weeks and objective sleep quality at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meditative movement, Breast cancer survivors, Qigong, Tai Chi Easy, Fatigue