Breast Cancer Clinical Trial
Official title:
Breast Cancer Survivors: Physical Activity, Inflammation, Fatigue, and Distress
RATIONALE: Yoga may improve inflammation, fatigue, and depression in female breast cancer
survivors.
PURPOSE: This randomized clinical trial is studying how well Hatha yoga works in improving
physical activity, inflammation, fatigue, and distress in female breast cancer survivors.
OBJECTIVES:
Primary
- To determine if the yoga intervention will decrease inflammation, fatigue, and
depressive symptoms relative to the waiting-list controls in women who are stage 0-IIIa
breast cancer survivors.
OUTLINE: Patients are stratified according to stage of cancer (stage 0 vs stage I vs stage
II and stage IIIA) and prior radiation therapy (yes vs no). Patients are randomized to 1 of
2 intervention arms.
- Arm I (waiting-list control): Patients are encouraged to perform usual activities, but
asked to refrain from any yoga practice or other related activities. After a six-month
observation period, patients undergo yoga intervention as described in arm II .
- Arm II (yoga intervention): Patients participate in a Hatha yoga intervention session
comprising body postures and breath control techniques for 1.5 hours twice a week for
12 weeks. Patients are encouraged to practice Hatha yoga at home. Patients complete
daily diaries on home Hatha yoga practices and submit them at each session.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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