Yoga in Treating Sleep Disturbance in Cancer Survivors (YOCAS)

Gary Morrow

Status and phase

Completed

Phase 2

Conditions

Sleep Disorders

Cancer

Fatigue

Treatments

Procedure: Standard Care Control Condition

Procedure: Yoga Intervention (YOCAS)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00397930

URCC-04-01 (Other Identifier)

U10CA037420 (U.S. NIH Grant/Contract)

CDR0000515123

URCC U3905 (Other Identifier)

Details and patient eligibility

About

RATIONALE: Yoga may help improve sleep, fatigue, and quality of life in cancer survivors.

PURPOSE: This phase II trial is studying how well yoga works in treating sleep disturbance in cancer survivors.

Full description

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.

Enrollment

410 patients

Sex

All

Ages

21 to 120 years old

Volunteers

No Healthy Volunteers

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