Yoga or Educational Wellness Class for Women With Stage I, Stage II, or Stage III Breast Cancer Undergoing Chemotherapy

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.

Inclusion Criteria:

Women will be eligible if they are:

- Scheduled to begin chemotherapy treatment within 3 weeks of study registration, or
able to start Yoga/Wellness sessions prior to second chemotherapy treatment.

- ≥18 years of age.

- Physically able to attend yoga classes (simply meaning that they can physically make
it to the intervention session and are able to sit on a chair or lie on the floor)
(ECOG Performance Status rating 0-2; Zubrod et al., 1960).

- Diagnosed with breast cancer Stages I-III.

- Chemotherapy is anticipated to continue during the 10 weeks of the study intervention.

- 2-8 weeks post-completion of breast surgery (unless receiving neoadjuvant
chemotherapy).

- Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

- Have practiced yoga on a regular basis (at least once a week) within the past 4 weeks
to recruit women who are not already regularly practicing yoga. Given that the
benefits of yoga are likely more immediate than long-term, however, we will enroll
women who have previously had a yoga practice.

- Are being treated with surgery and/or radiation therapy and/or hormonal treatment only
and/or Herceptin therapy only (no chemotherapy).

- Anticipate undergoing surgery related to their breast cancer or receipt of radiation
therapy during the study period.

- Have regularly engaged in moderate (activity that makes you breathe somewhat harder
than normal; may include carrying light loads, bicycling at a regular pace, fast
walking, tennis, easy swimming, or popular or folk dancing) or vigorous (activity that
causes heavy breathing, sweating, rapid fatigue; it can only be sustained for very
short periods of time, like running or swimming strongly) physical activity at least
3-5 days per week (on average) within the past 4 weeks.

Pregnant women will not be excluded from this study because the study intervention(s) pose
no risk of potential for teratogenic or abortifacient effects. In fact, gentle yoga
practice is quite safe for pregnant women and poses can be slightly modified, if needed.
The anticipated number of pregnant women eligible to enroll is minimal.