Fatigue Clinical Trial
Official title:
Effects of Meditative Movement (Qigong/Tai Chi Easy) on Fatigued Breast Cancer Survivors
Verified date | June 2021 |
Source | Arizona State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 232 |
Est. completion date | December 30, 2020 |
Est. primary completion date | December 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 45 Years to 75 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Arizona State University | Phoenix | Arizona |
Lead Sponsor | Collaborator |
---|---|
Arizona State University | Mayo Clinic, University of Arizona |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Functional Assessment of Cancer Therapy-Cognitive Function Neuropathy (FACT-COGNtx) | Peripheral Neuropathy | Change from baseline peripheral neuropathy to peripheral neuropathy at 8 weeks and peripheral neuropathy at 6 months | |
Primary | Fatigue Symptom Inventory | Fatigue | Change from baseline fatigue to fatigue at 8 weeks and fatigue at 6 months. | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | Pittsburgh Sleep Quality Index (PSQI) | Sleep quality | Change from baseline sleep quality to sleep quality at 8 weeks and sleep quality at 6 months | |
Secondary | 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 | |
Secondary | Venipuncture for serum using MILLIPLEX MAP Human Cytokine/Chemokine Magnetic Bead Panel kits | Inflammatory biomarkers (IL-1ß, IL-6,TNF-a; IFN-?) | Change from baseline Inflammatory biomarkers (IL-1ß, IL-6,TNF-a; IFN-?) to Inflammatory biomarkers at 8 weeks | |
Secondary | Diurnal salivary samples (enzyme assay) | Salivary cortisol | Change from baseline salivary cortisol to salivary cortisol at 8 weeks | |
Secondary | 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 | |
Secondary | 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 |
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