YOCAS II-A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy for Treating Insomnia in Cancer Survivors

This randomized phase III trial compares yoga, survivorship health education program, and cognitive behavioral therapy in reducing sleep disturbance (insomnia) in cancer survivors. Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty staying asleep, or waking up earlier than desired. Insomnia can increase fatigue, impair physical function, impair immune function, cause circadian rhythms (known as the biological clock) to be disrupted and decrease quality of life. Yoga may improve circadian rhythms, physical and immune function, and improve insomnia and sleep quality in cancer survivors. It is not yet known whether yoga is more effective at treating insomnia than a health education program or cognitive behavioral therapy program.

Inclusion Criteria:

* Have a confirmed diagnosis of cancer
* Have received surgery, chemotherapy, and/or radiation therapy
* Have completed all surgery, chemotherapy and/or radiation therapy within the last 2-24 months
* Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria for insomnia and score >= 10 on the Insomnia Severity Index
* Be able to read and understand English
* Be able to provide written informed consent

Exclusion Criteria:

* Have contraindications to functional testing or yoga participation according to the treating physician
* Have practiced yoga >= 1 day a week within the 3 months prior to enrolling in the study
* Be planning to start yoga on their own during the time they are enrolled in the study
* Have a confirmed diagnosis of sleep apnea or restless leg syndrome
* Be receiving any form of treatment for cancer with the exception of hormonal or biologic therapy
* Have distant metastases
Phase III
Alison Conlin, M.D.
URCC NCORP Research Base
Shivaun Schmidt

The Pacific Cancer Research Consortium clinical trials are offered at multiple locations throughout Oregon, Washington, Alaska, California, and Idaho. To find a location near you, please contact the Patient Engagement Center at 844-552-2734.