Hatha Yoga in Improving Physical Activity, Inflammation, Fatigue, and Distress in Breast Cancer Survivors
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.
Other: flow cytometry
Other: immunoenzyme technique
Procedure: fatigue assessment and management
Procedure: management of therapy complications
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
Procedure: yoga therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||Breast Cancer Survivors: Physical Activity, Inflammation, Fatigue, and Distress|
- Proinflammatory cytokines
- Depressive symptoms
- Psychological (quality of life, perceived stress, and stress responsiveness)
- Behavioral (health behaviors)
- Physical functioning (physical symptoms, pain, flexibility, and functional status)
- Physiological stress responses (NF-κB and proinflammatory cytokine responses to a laboratory stressor assessed at baseline)
|Study Start Date:||August 2007|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
- To determine if the yoga intervention will decrease inflammation, fatigue, and depressive symptoms relative to the waiting-list controls in women who are stage I-IIIa breast cancer survivors.
- To determine the extent to which the yoga intervention modulates psychological, behavioral, and physical functioning in these patients.
- To evaluate the relationship between depressive symptoms and the magnitude of the physiological responses elicited by a laboratory stressor, as well as the relationship of both to fatigue in these patients.
- To assess the extent to which the yoga intervention will decrease physiological stress responses in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to stage of cancer (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 with the support of appropriate monthly DVD/video segments. Patients complete daily diaries on home Hatha yoga practices and submit them at each session.
In both arms, patients are physically assessed, interviewed, and then complete heath and health-related behavior questionnaires regarding psychological (quality of life, perceived stress, and stress responsiveness), behavioral (health behaviors), physical functioning (physical symptoms, pain, flexibility, and functional status), and physiological stress responses (NF-κB and proinflammatory cytokine responses to a laboratory stressor) at baseline, 3 months, and 6 months.
Patients undergo fasting blood sample collection at baseline, 3 months, and 6 months to analyze fatty acid composition of plasma by gas chromatography, changes in immune function, proinflammatory cytokine, and key inflammation markers of fatigue and stress by ELISA, flow cytometry, and indirect immunofluorescence (IF) test. Additionally, patient response to laboratory stressors are assessed at baseline using the Trier Social Stress Test (TSST). Saliva samples are collected periodically and before and after the TSST for cortisol level measurement.
|United States, Ohio|
|Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center|
|Columbus, Ohio, United States, 43210-1240|
|Study Chair:||Janice Kiecolt-Glaser, PhD||Ohio State University Comprehensive Cancer Center|