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

Insomnia Clinical Trial

— YOCAS-II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613364
• Other study ID #: URCC14040
• Secondary ID: NCI-2015-01144RS
• Status: Completed
• Phase: N/A
• Start date: August 31, 2016
• Est. completion date: February 4, 2020

Study information

• Verified date: April 2024
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 746
• Est. completion date: February 4, 2020
• Est. primary completion date: February 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Survivor
• Insomnia
• Malignant Neoplasm
• Neoplasms
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Behavioral Intervention
Undergo yoga intervention

Other:
• Cognitive Intervention
Undergo CBT-I intervention
• Educational Intervention
Receive health education
• Laboratory Biomarker Analysis
Correlative studies

Device:
• Monitoring Device
Correlative studies

Other:
• Quality-of-Life Assessment
Ancillary studies

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester NCORP Research Base	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in the ISI Comparing YOCAS vs. CBT-I	The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. Means and 95% confidence intervals for YOCAS and CBT-I will be calculated and plotted and examined in comparison with the a priori specified non-inferiority margin of 1.15.	Baseline up to post intervention (approximately 4 to 8 weeks)
Primary	Mean Change in the ISI Comparing YOCAS vs. Health Education	The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.	Baseline up to post intervention (approximately 4 to 8 weeks)
Secondary	Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. Health Education	The PSQI measures sleep quality with a total score ranging from 0-21 with higher scores indicating worse sleep quality. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.	Baseline up to post intervention (approximately 4 to 8 weeks)
Secondary	Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. CBT-I.	The PSQI measures sleep quality with a total score ranging from 0-21 with higher scores indicating worse sleep quality. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.	Baseline up to post intervention (approximately 4 to 8 weeks)
Secondary	Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. Health Education	Actigraphy will measure the number of minutes of actual sleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.	Baseline up to post intervention (approximately 4 to 8 weeks)
Secondary	Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. CBT-I	Actigraphy will measure the number of minutes of actual sleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.	Baseline up to post intervention (approximately 4 to 8 weeks)
Secondary	Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. Health Education	Actigraphy will measure total minutes of wake time after sleep onset. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education. The transformation of the log base 10 of the original measurement was used for the analysis.	Baseline up to post intervention (approximately 4 to 8 weeks)
Secondary	Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. CBT-I	Actigraphy will measure total minutes of wake time after sleep onset. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I. The transformation of log base 10 of the original measurement was used for the analysis.	Baseline up to post intervention (approximately 4 to 8 weeks)
Secondary	Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. Health Education	Actigraphy will measure the percent of time actually slept compared to intended time sleeping. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.	Baseline up to post intervention (approximately 4 to 8 weeks)
Secondary	Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. CBT-I	Actigraphy will measure the percent of time actually slept compared to intended time sleeping. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.	Baseline up to post intervention (approximately 4 to 8 weeks)
Secondary	Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. Health Education	Actigraphy will measure the minutes it takes for the participant to fall asleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education. The transformation of log base 10 of the (measurement + 1) was used in the analysis.	Baseline up to post intervention (approximately 4 to 8 weeks)
Secondary	Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. CBT-I	Actigraphy will measure the minutes it takes for the participant to fall asleep. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I. The transformation of the log base 10 of the (measure + 1) was used in the analysis.	Baseline up to post intervention (approximately 4 to 8 weeks)
Secondary	Mean Change in the ISI Comparing YOCAS and Health Education (3 Month)	The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.	Baseline to 3 months
Secondary	Mean Change in the ISI Comparing YOCAS and CBT-I (3 Month)	The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.	Baseline to 3 months
Secondary	Mean Change in the ISI Comparing YOCAS and Health Education (6 Month)	The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and health education.	Baseline to 6 months
Secondary	Mean Change in the ISI Comparing YOCAS and CBT-I (6 Month)	The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change between YOCAS and CBT-I.	Baseline to 6 months