Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy in Reducing Insomnia in Cancer Survivors

Completed · Not applicable

Conditions studied: Cancer Survivor, Insomnia, Malignant Neoplasm

In brief

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.

Key facts

Study ID

NCT02613364

Run by

University of Rochester NCORP Research Base

People needed

746

Starts

2016-08-31

Expected to finish

2020-02-04

Last updated by the study team

2024-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 2-60 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

You may not qualify if…

• 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

Where it is running

• Hawaii MU NCORP — Honolulu, Hawaii, United States
• Heartland NCORP — Decatur, Illinois, United States
• Wichita NCORP — Wichita, Kansas, United States
• Gulf South MU-NCORP — New Orleans, Louisiana, United States
• Michigan Cancer Research Consortium NCORP — Ann Arbor, Michigan, United States
• Cancer Research Consortium of West Michigan — Grand Rapids, Michigan, United States
• Metro-Minnesota NCORP — Minneapolis, Minnesota, United States
• Nevada Cancer Research Foundation NCORP — Las Vegas, Nevada, United States
• University of Rochester NCORP Research Base — Rochester, New York, United States
• Southeast Clinical Oncology Research Consortium — Winston-Salem, North Carolina, United States
• Columbus NCORP — Columbus, Ohio, United States
• Dayton Clinical Oncology Program — Dayton, Ohio, United States
• Pacific Cancer Research Consortium Ncorp — Portland, Oregon, United States
• Greenville Health System NCORP — Greenville, South Carolina, United States
• Wisconsin NCORP — Marshfield, Wisconsin, United States
• Aurora NCORP — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.