Trial Information

Yoga or Wellness Education During Breast Cancer Treatment: Establishing Community-Based Partnerships

OBJECTIVES:

Primary

- 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.

Secondary

- 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.