NCT02613364

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 746 (actual)
• Sponsor: University of Rochester NCORP Research Base · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine if Yoga for Cancer Survivors (YOCAS) is effective for improving patient-reported insomnia (Insomnia Severity Index) compared to Cognitive Behavioral Therapy for Insomnia (CBT-I) and a health education control immediately post intervention. SECONDARY OBJECTIVES: I. To examine if YOCAS is effective for improving objective symptoms of insomnia (sleep latency, sleep efficiency, wake after sleep onset, sleep duration, and daytime napping via actigraphy) and global sleep quality impairment (Pittsburgh Sleep Quality Index) compared to CBT-I and a health education control. II. To examine if YOCAS and CBT-I are effective for maintaining improvements in insomnia (Insomnia Severity Index) 3 and 6 months post intervention compared to a health education control. OUTLINE: Patients are randomized to 1 of 3 arms. ARM I: Patients undergo the YOCAS intervention comprising 18 specific physical postures and mindfulness exercises focused on breathing and meditation and meet with the yoga instructor over 75 minutes 2 times a week for 4 weeks. ARM II: Patients undergo CBT-I intervention comprising sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention delivered by a health professional over 90 minutes once a week for 8 weeks. ARM III: Patients attend survivorship health education sessions over 75 minutes 2 times a week for 4 weeks based on the American Society of Clinical Oncology cancer survivorship educational recommendations delivered by a community health educator. Patients also receive a booklet entitled, "Cancer Survivorship Next Steps for Patients and Their Families." After completion of intervention, patients are followed up at 3 and 6 months.

Conditions

• Cancer Survivor
• Insomnia
• Malignant Neoplasm

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral Intervention	Undergo yoga intervention
OTHER	Cognitive Intervention	Undergo CBT-I intervention
OTHER	Educational Intervention	Receive health education
OTHER	Laboratory Biomarker Analysis	Correlative studies
DEVICE	Monitoring Device	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2016-08-31
• Primary completion: 2020-02-04
• Completion: 2020-02-04
• First posted: 2015-11-24
• Last updated: 2024-05-01
• Results posted: 2021-03-23

Locations

16 sites across 1 country: United States