Hatha Yoga in Improving Physical Activity, Inflammation, Fatigue, and Distress in Breast Cancer Survivors
- Conditions
- Breast CancerDepressionFatiguePain
- Interventions
- Procedure: Yoga Therapy
- Registration Number
- NCT00486525
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I: Yoga Therapy Yoga Therapy Patients participate in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients are also encouraged to practice yoga at home using the appropriate DVD/video segments for the month.
- Primary Outcome Measures
Name Time Method Stimulated ln (TNF-a) Immediately post-treatment and 3 months post-treatment log-transformed Lipopolysaccharide (LPS) stimulated Tumor Necrosis Factor-alpha (TNF-alpha)
Stimulated ln (IL-6) Immediately post-treatment and 3 months post-treatment log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-6 (IL-6)
Stimulated ln (IL-1b) Immediately post-treatment and 3 months post-treatment log-transformed Lipopolysaccharide (LPS) stimulated Interleukin-1 beta (IL-1b)
MFSI-SF Fatigue Immediately post-treatment and 3 months post-treatment The 30-item Multidimensional Fatigue Symptom Inventory-Short form (MFSI-SF) assesses behavioral, cognitive, physical, and affective expressions of fatigue.
Items are rated on a 5-point scale indicating how true each statement was for the respondent during the last week (0=not at all; 4=extremely). The total score represents the sum of the subscales measuring general, physical, emotional, and mental fatigue, minus the vigor scale, providing a possible range of scores from -24 to 96, with higher scores indicating greater fatigue.Vitality, SF-36 Immediately post-treatment and 3 months post-treatment The SF-36's (RAND Health Survey) energy/fatigue (vitality) scale focuses on the frequency of feelings of fatigue over the last month.
Standardized scores on the RAND SF-36 vigor/vitality scale range from 0-100, with higher scores indicating less fatigue.CES-D Immediately post-treatment and 3 months post-treatment The Center for Epidemiological Studies Depression Scale (CES-D) is a self-report scale designed to measure current symptoms of depression rated on a four-point likert scale.
Scores range from 0-60, with higher scores indicating a higher frequency of depressive symptoms.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
🇺🇸Columbus, Ohio, United States