Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy in Reducing Insomnia in Cancer Survivors (YOCAS-II)

University of Rochester NCORP Research Base

Status: Completed

Conditions: Malignant Neoplasm; Insomnia; Cancer Survivor

Treatments: Behavioral: Behavioral Intervention; Other: Educational Intervention; Other: Laboratory Biomarker Analysis; Other: Cognitive Intervention; Device: Monitoring Device; Other: Quality-of-Life Assessment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02613364

UG1CA189961 (U.S. NIH Grant/Contract)

RSRB052271 (Other Identifier)

R01CA181064 (U.S. NIH Grant/Contract)

URCC-14040 (Other Identifier)

URCC14040 (Other Identifier)

NCI-2015-01144 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 746 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 2-60 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

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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746 participants in 3 patient groups

Arm I (behavioral intervention-yoga)

Experimental group

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Device: Monitoring Device

Behavioral: Behavioral Intervention

Other: Laboratory Biomarker Analysis

Arm II (cognitive intervention-CBT-I)

Experimental group

Description:

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.

Treatment:

Other: Quality-of-Life Assessment

Device: Monitoring Device

Other: Laboratory Biomarker Analysis

Other: Cognitive Intervention

Arm III (educational intervention)

Active Comparator group

Description:

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."

Treatment:

Other: Quality-of-Life Assessment

Device: Monitoring Device

Other: Educational Intervention

Other: Laboratory Biomarker Analysis