Yoga or Educational Wellness Class for Women With Stage I, Stage II, or Stage III Breast Cancer Undergoing Chemotherapy
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|ClinicalTrials.gov Identifier: NCT00994279|
Recruitment Status : Completed
First Posted : October 14, 2009
Results First Posted : March 9, 2017
Last Update Posted : December 21, 2017
RATIONALE: Yoga and wellness classes may reduce fatigue and improve mood, sleep, and quality of life in women receiving chemotherapy for breast cancer. It is not yet known whether yoga is more effective than wellness education for women with breast cancer who are undergoing chemotherapy.
PURPOSE: This randomized phase II trial is studying a community-based yoga class to see how well it works compared with an educational wellness class for women with stage I, stage II, or stage III breast cancer undergoing chemotherapy.
|Condition or disease||Intervention/treatment|
|Breast Cancer Depression Fatigue Sleep Disorders||Behavioral: Yoga Behavioral: Education|
- To estimate the participation rate, accrual, adherence, and retention to a community-based study of yoga vs an active control (wellness education) in women with stage I-III breast cancer undergoing chemotherapy.
- To obtain estimates of the variability of women's self-reported fatigue and depressive symptoms, sleep quality, and health-related quality of life from baseline to the end of the intervention at 10 weeks.
- To obtain estimates of the efficacy of a community-based yoga intervention in women with breast cancer.
- To standardize the yoga protocol for use in multiple community settings with breast cancer patients, and ascertain that yoga teachers can adhere to a uniform protocol.
OUTLINE: This is a multicenter study. Patients are stratified according to CCOP site and chemotherapy-treatment status (planning vs started). Patients are randomized to 1 of 2 intervention arms.
Patients must begin their class or group within 3 weeks of starting chemotherapy. All women enter their class or group on a rolling basis so that their class or group coincides with the weeks that they receive chemotherapy treatments.
- Arm I (Yoga intervention): In weeks 1-10, patients attend a community-based weekly 75-minute Integral Yoga class led by an experienced yoga teacher specifically trained in adapting yoga for people with cancer. The yoga class includes postures, deep relaxation, breathing practices, and meditation to create a profound experience of peace and well-being. Women are asked to attend ≥ 8 of 10 classes over a 12-week period to allow for missed classes. Women are also provided with a yoga mat, associated yoga props (bolster, strap), and a 45-minute cancer-specific yoga DVD for home practice. Women are asked to practice yoga outside of the class at least twice per week, and are encouraged to practice more frequently than that.
- Arm II (Active control): Patients meet for a weekly 75-minute wellness education group in weeks 1-10 (women may make-up missed classes during weeks 11 and 12). The group focuses on issues that women with breast cancer face as they undergo treatment; topics include symptom management, financial and insurance issues, emotional issues/coping with cancer, communicating with healthcare providers/navigating the healthcare system, healthful eating/cooking demonstrations, sexual issues/fertility/body image, mobilizing social support/impact of cancer on family and friends, survivorship (advocacy) opportunities, and common concerns/fear of recurrence. Women are provided with reading materials relevant to the topics that will be covered in each group meeting and are asked to spend approximately 45 minutes twice weekly reading these materials and incorporating any relevant principles/ideas into their daily lives. Women may request additional reading materials in further topics of interest from the group facilitators.
Patients complete questionnaires at baseline and at weeks 5, 10, and 14 to assess fatigue (FACIT-Fatigue), depressive symptoms (Center for Epidemiologic Studies-Depression Scale [CES-D]), treatment-related symptoms (M.D. Anderson Symptom Inventory [MDASI]), sleep disturbance (Medical Outcomes Study Sleep Measure [MOS-Sleep]), and health-related quality of life (Functional Assessment of Cancer Therapy-Breast [FACT-B]). Patients also track time spent on all home-yoga practice (arm I) or wellness-group homework (arm II). After the intervention (week 10), patients are asked to provide feedback on the program. Yoga/Wellness teachers will completion intervention feedback forms 6 months from the start of the first intervention and at completion of the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Yoga or Wellness Education During Breast Cancer Treatment: Establishing Community-Based Partnerships|
|Study Start Date :||October 2009|
|Primary Completion Date :||August 2011|
|Study Completion Date :||October 2011|
Active Comparator: Arm 1: Yoga Intervention
Active Comparator: Arm 2: Educational Wellness Group
Educational Wellness Group
Educational Wellness Group
- Retention [ Time Frame: 10 weeks ]Proportion of participants completing the 10 week study
- Fatigue at 10 Weeks [ Time Frame: 10 weeks ]FACIT-Fatigue patient reported outcome. This questionnaire consists of 13 questions answered on a 0 to 4 scale with a min of 0 and a max of 52. Higher scores indicate less fatigue.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00994279
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Principal Investigator:||Edward G. Shaw, MD||Wake Forest University Health Sciences|