Clinical trial NCT02613364: Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy in Reducing Insomnia in Cancer Survivors
Official title: A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy for Treating Insomnia in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivor
Insomnia
Malignant Neoplasm
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-11-24
Enrollment: 746
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Change in the ISI Comparing YOCAS vs. CBT-I
timeFrame: Baseline up to post intervention (approximately 4 to 8 weeks)
measure: Mean Change in the ISI Comparing YOCAS vs. Health Education
timeFrame: Baseline up to post intervention (approximately 4 to 8 weeks)
Secondary outcomes:
measure: Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. Health Education
timeFrame: Baseline up to post intervention (approximately 4 to 8 weeks)
measure: Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. CBT-I.
timeFrame: Baseline up to post intervention (approximately 4 to 8 weeks)
measure: Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. Health Education
timeFrame: Baseline up to post intervention (approximately 4 to 8 weeks)
measure: Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. CBT-I
timeFrame: Baseline up to post intervention (approximately 4 to 8 weeks)
measure: Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. Health Education
timeFrame: Baseline up to post intervention (approximately 4 to 8 weeks)
measure: Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. CBT-I
timeFrame: Baseline up to post intervention (approximately 4 to 8 weeks)
measure: Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. Health Education
timeFrame: Baseline up to post intervention (approximately 4 to 8 weeks)
measure: Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. CBT-I
timeFrame: Baseline up to post intervention (approximately 4 to 8 weeks)
measure: Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. Health Education
timeFrame: Baseline up to post intervention (approximately 4 to 8 weeks)
measure: Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. CBT-I
timeFrame: Baseline up to post intervention (approximately 4 to 8 weeks)
measure: Mean Change in the ISI Comparing YOCAS and Health Education (3 Month)
timeFrame: Baseline to 3 months
measure: Mean Change in the ISI Comparing YOCAS and CBT-I (3 Month)
timeFrame: Baseline to 3 months
measure: Mean Change in the ISI Comparing YOCAS and Health Education (6 Month)
timeFrame: Baseline to 6 months
measure: Mean Change in the ISI Comparing YOCAS and CBT-I (6 Month)
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Hawaii MU NCORP
state: Hawaii
city: Decatur
country: United States
facility: Heartland NCORP
state: Illinois
city: Wichita
country: United States
facility: Wichita NCORP
state: Kansas
city: New Orleans
country: United States
facility: Gulf South MU-NCORP
state: Louisiana
city: Ann Arbor
country: United States
facility: Michigan Cancer Research Consortium NCORP
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer Research Consortium of West Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Metro-Minnesota NCORP
state: Minnesota
city: Las Vegas
country: United States
facility: Nevada Cancer Research Foundation NCORP
state: Nevada
city: Rochester
country: United States
facility: University of Rochester NCORP Research Base
state: New York
city: Winston-Salem
country: United States
facility: Southeast Clinical Oncology Research Consortium
state: North Carolina
city: Columbus
country: United States
facility: Columbus NCORP
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Oncology Program
state: Ohio
city: Portland
country: United States
facility: Pacific Cancer Research Consortium Ncorp
state: Oregon
city: Greenville
country: United States
facility: Greenville Health System NCORP
state: South Carolina
city: Marshfield
country: United States
facility: Wisconsin NCORP
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora NCORP
state: Wisconsin
Study officials:
affiliation: University of Rochester NCORP Research Base
name: Karen Mustian
role: PRINCIPAL_INVESTIGATOR
References: