Yoga in Relieving Fatigue in Patients Undergoing Chemotherapy for Ovarian Cancer
|ClinicalTrials.gov Identifier: NCT00856453|
Recruitment Status : Terminated (slow accrual)
First Posted : March 5, 2009
Last Update Posted : May 30, 2017
RATIONALE: Yoga may decrease fatigue, distress, and depression, and improve sleep quality in patients undergoing chemotherapy for ovarian cancer. It is not yet known whether practicing yoga in group classes is more effective than practicing yoga at home.
PURPOSE: This randomized clinical trial is studying how well yoga works in relieving fatigue in patients undergoing chemotherapy for ovarian cancer.
|Condition or disease||Intervention/treatment||Phase|
|Depression Fatigue Ovarian Cancer||Behavioral: Home yoga practice Behavioral: yoga classes||Not Applicable|
- Examine the effectiveness of a restorative yoga (RY) intervention vs home yoga practice in patients undergoing chemotherapy for ovarian cancer.
- Examine the effectiveness of RY vs home yoga practice on depression, distress, and sleep quality in these patients.
- Examine the acute (pre- and post-yoga class) effects in these patients.
- Test the feasibility of using behavioral strategies to enhance yoga intervention adherence.
OUTLINE: Patients are randomized to 1 of 2 arms.
- Arm I (restorative yoga intervention): Patients attend 45-minute group yoga classes every 3 weeks on the days they are scheduled for chemotherapy for approximately 5-6 sessions. Patients are provided with a yoga DVD, a manual with photos and written descriptions/guidance to practice yoga postures at home, and basic yoga equipment (yoga mat, strap, block, yoga blankets) and instructed to practice to the DVD 3 times per week (twice weekly during week of group yoga class) for ≥ 45 minutes. Patients record yoga practice time/activity at the third yoga session of each week.
- Arm II (home yoga practice): Patients are provided with a yoga DVD, a manual with photos and written descriptions/guidance to practice yoga postures at home, and basic yoga equipment (yoga mat, strap, block, yoga blankets) and instructed to practice to the DVD 3 times per week for ≥ 45 minutes. Patients record yoga practice time/activity at the third yoga session of each week.
All patients complete questionnaires at baseline, at weeks 9, 18, and 22. Self-report measures include Distress Thermometer, Positive and Negative Affect Schedule, Center for Epidemiologic Studies-Depression Scale, M.D. Anderson Symptom Inventory, Functional Assessment of Cancer Therapy - Ovarian, Functional Assessment of Chronic Illness Therapy (FACIT) - Spiritual Subscale, FACIT- Fatigue Subscale, State-Trait Anxiety Inventory, Women's Health Initiative Insomnia Rating Scale, Medical Outcome Study-Social Support Survey, Integrative Medicine Use, Pre- and Post- Class Ratings, and Intervention Feedback .
After completion of study, patients are followed at 4 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Restorative Yoga for Women With Ovarian Cancer Undergoing Chemotherapy|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
|Experimental: Yoga classes plus home yoga practic||
Behavioral: Home yoga practice
training for and tracking of patient's practice of yoga at homeBehavioral: yoga classes
organized out of home classes for yoga
|Experimental: home yoga practice alone||
Behavioral: Home yoga practice
training for and tracking of patient's practice of yoga at home
- Self-reported fatigue [ Time Frame: 22 weeks ]
- Self-reported distress, depression, and sleep quality [ Time Frame: 22 weeks ]
- Pre- and post-yoga class change in symptom/distress ratings [ Time Frame: 22 weeks ]
- Yoga intervention adherence [ Time Frame: 18 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00856453
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Principal Investigator:||Suzanne C. Danhauer, PhD||Wake Forest University Health Sciences|
|Principal Investigator:||Brigitte E. Miller, MD||Wake Forest University Health Sciences|