Yoga in Treating Sleep Disturbance in Cancer Survivors

OBJECTIVES:

Primary

- Determine the efficacy of Hatha yoga in improving sleep quality in cancer survivors
experiencing persistent sleep disturbance.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
gender and sleep disturbance rating reported on the eligibility assessment questionnaire (≤
5 vs > 5). Patients are randomized to 1 of 2 arms.

- Arm I: Patients receive standard care for 6 weeks. Patients may switch to the yoga
intervention immediately after study completion.

- Arm II:Patients receive standard care for 2 weeks, followed by two 75-minute sessions
of Hatha yoga per week for 4 weeks.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Inclusion Criteria:

- Diagnosis of any type of cancer

- More than 1 primary cancer allowed

- Has undergone and completed all forms of standard treatment (surgery, chemotherapy,
radiation therapy) within the past 2 to 24 months

- Patients can be on hormones such as Tamoxifen, or monoclonal antibodies like
Herceptin

- Persistent sleep disturbance, as indicated by a response of ≥ 3 when asked to rate
their sleep on an 11-point scale (0 is equivalent to no sleep disturbance and 10 is
the worst possible sleep disturbance)

- Able to read English

- 21 years of age or older

Exclusion Criteria:

- No prior or concurrent regular (≥ 1 day/week) participation in yoga classes or
maintain regular personal practice of any form of yoga within the past 3 months

- No diagnosis of sleep apnea

- No concurrent cancer therapy with the exception of hormonal therapy (e.g., tamoxifen
citrate) or monoclonal antibodies (e.g., trastuzumab [Herceptin®])

- No metastatic cancer