Clinical Trial: Reducing Insomnia of Cancer Survivors with Yoga vs. Health Education and Cognitive Behavioral Therapy
How can myeloma patients sleep better when living with cancer? A new phase III study is comparing three groups: yoga, survivorship health education and cognitive behavior therapy to see which is most effective in reducing insomnia in cancer survivors.
Insomnia is 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.
The trial will 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.
Patients will be 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 study, patients are followed up at 3 and 6 months.
This study is currently recruiting 630 cancer survivors 18 years and older. One must have: a confirmed diagnosis of cancer; received chemotherapy, radiation therapy, or surgery; completed all chemotherapy, surgery, or radiation therapy within the past 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/understand English; and be able to provide written informed consent.
This trial excludes anyone who cannot participate in yoga (based on doctor suggestions), has practiced yoga more than 1 day a week within the 3 months prior to enrolling in the study; is planning to start yoga on their own during the time they are enrolled in the study; has a confirmed diagnosis of sleep apnea or restless leg syndrome; is receiving any form of treatment for cancer with the exception of hormonal or biologic therapy; or has metastatic cancer.
To learn more about this study (which is hosted at 16 locations across the country), visit the website.