Symptoms and General Pathology

All Conditions

Nervous System Diseases

Behaviors and Mental Disorders

Fatigue

Dyssomnias

Parasomnias

Sleep Wake Disorders

Neurologic Manifestations

Mental Disorders

Psychotic Disorders

Standardized Yoga for Cancer Survivors (YOCAS)

Standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses.

Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.

Standard Care Control Condition

The Yoga for Cancer Survivors (YOCAS) intervention uses two forms of yoga: Gentle Hatha yoga and Restorative yoga. The YOCAS sessions are standardized, and each session includes physical alignment postures, breathing and mindfulness exercises. The intervention is delivered in an instructor taught, group format, twice a week for 75 minutes each time over 4 weeks for a total of eight sessions of yoga. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.

Yoga Intervention (YOCAS)

Karen M. Mustian, PhD

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.

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.

Yoga in Treating Sleep Disturbance in Cancer Survivors

Yoga for Persistent Sleep Disturbance in Cancer Survivors

Pittsburgh Sleep Quality Index: Measures sleep disturbance and usual sleep habits during the prior month only using seven clinically derived domains of sleep difficulties: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Global PSQI is a summary of the seven domains. Each Domain is scored from 0 to 3, therefore PSQI has a range of 0 (better) to 21 (worse). Interpretation of the PSQI is that a score less than 5 is associated with good sleep quality and a score of 5 or greater is associated with poor sleep quality.

PSQI was calculated at both pre- and post-intervention for both arms. Pre-intervention PSQI was recorded during the week immediately before commencing the 4-week intervention. Post-intervention PSQI was recorded during the week immediately following the intervention. Mean post-pre change was calculated for both arms.

National Cancer Institute (NCI)

Gary Morrow

Director, URCC NCORP Research Base

The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.

fatigue assessment and management

management of therapy complications

quality-of-life assessment

sleep disorder therapy

yoga therapy

The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.

fatigue assessment and management

management of therapy complications

quality-of-life assessment

Total

Age, Customized

Gender

White

African American

Other

Race/Ethnicity, Customized

United States

Region of Enrollment

Currently employed

Married or long-term committed relationship

Divorced or separated

Single

Widowed

Unknown

Marital status

Completed 4 years of college or more

Completed < 4 years of college

High school graduate

Less than a high school graduate

Education

Breast

Hematologic

Gynecologic

Alimentary

Cancer type

Cancer stage

Previous treatment - Surgery

Previous Treatment - Chemotherapy

Previous Treatment - Radiation therapy

Previous Treatment - Hormone treatment

Current hormone therapy

Time since first treatment for cancer

The Karnofsky Performance Scale (KPS) Index allows patients to be classified as to their functional impairment. Essentially as used in oncology, the KPS is a measure of time to death. A higher score is favorable. There are 3 general categories which are broken down into 11 specific criteria. Scale range is from 0 (Dead) to 100 (Normal, no complaints, no evidence of disease). The scale increases in units of 10.

Karnofsky performance status

Not exercising and do not intend to in next 6 mo

Not exercising but intend to in next 6 mo

Not exercising but intend to begin in next 30 days

Exercising and have been for less than 6 months

Exercising and have been for more than 6 months

Exercise stage of change

The study did not account for components such as time or attention, as this would have required the use of a placebo yoga intervention for the YOCAS program. The results are not generalizable for all yoga types, nor for all socioeconomic backgrounds.

Charles E. Heckler, PhD, MS. Research Assistant Professor

H0: There is no statistically significant difference in global sleep quality between post-treatment cancer survivors under the standardized yoga intervention and control protocol at the 0.05 two-sided significance level.

Ha: There is a statistically significant difference in global sleep quality between post-treatment cancer survivors under the standardized yoga intervention and control protocol at the 0.05 two-sided significance level.

Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI)

Overall Study

Spots Global Cancer Trial Database for standard care control condition