Fatigue
Conditions
Keywords
Meditative movement, Breast cancer survivors, Qigong, Tai Chi Easy, Fatigue
Brief summary
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
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.
Interventions
OTHERQigong/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.
OTHERSham 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.
OTHEREducational 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.
Sponsors
University of Arizona
Mayo Clinic
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 75 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Symptom Inventory | Change from baseline fatigue to fatigue at 8 weeks and fatigue at 6 months. | Fatigue |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG) | Change from baseline cognitive function to cognitive function at 8 weeks and cognitive function at 6 months. | Cognitive function |
| Pittsburgh Sleep Quality Index (PSQI) | Change from baseline sleep quality to sleep quality at 8 weeks and sleep quality at 6 months | Sleep quality |
| Women's Health Initiative Brief Physical Activity Questionnaire (WHI-BPAQ) | Change from baseline physical activity (PA) to PA at 8 weeks and PA at 6 months | Physical activity |
| Profile of Mood States Short Form (POMS-SF) | Change from baseline anxiety and depression to anxiety and depression at 8 weeks and anxiety and depression at 6 months. | Anxiety and depression |
| Diurnal salivary samples (enzyme assay) | Change from baseline salivary cortisol to salivary cortisol at 8 weeks | Salivary cortisol |
| ActiGraph GT3X activity monitor | Change from baseline objective physical activity to objective physical activity at 8 weeks and objective physical activity at 6 months | Objective measurement of physical activity |
| Venipuncture for serum using MILLIPLEX MAP Human Cytokine/Chemokine Magnetic Bead Panel kits | Change from baseline Inflammatory biomarkers (IL-1β, IL-6,TNF-α; IFN-γ) to Inflammatory biomarkers at 8 weeks | Inflammatory biomarkers (IL-1β, IL-6,TNF-α; IFN-γ) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Cancer Therapy-Cognitive Function Neuropathy (FACT-COGNtx) | Change from baseline peripheral neuropathy to peripheral neuropathy at 8 weeks and peripheral neuropathy at 6 months | Peripheral Neuropathy |
Countries
United States
Outcome results
None listed