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

• ClinicalTrials.gov Identifier: NCT02613364
• Recruitment Status: Completed
• First Posted: November 24, 2015
• Results First Posted: March 23, 2021
• Last Update Posted: May 1, 2024
• Sponsor: University of Rochester NCORP Research Base
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Karen Mustian, University of Rochester NCORP Research Base

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cancer Survivor; Insomnia; Malignant Neoplasm	Behavioral: Behavioral Intervention; Other: Cognitive Intervention; Other: Educational Intervention; Other: Laboratory Biomarker Analysis; Device: Monitoring Device; Other: Quality-of-Life Assessment	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 746 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy for Treating Insomnia in Cancer Survivors
• Actual Study Start Date: August 31, 2016
• Actual Primary Completion Date: February 4, 2020
• Actual Study Completion Date: February 4, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm I (behavioral intervention-yoga); 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.	Behavioral: Behavioral Intervention; Undergo yoga intervention; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; BEHAVIORAL THERAPY; Behavioral Treatment; Behavioral Treatments; Other: Laboratory Biomarker Analysis; Correlative studies; Device: Monitoring Device; Correlative studies; Other Name: Monitor; Other: Quality-of-Life Assessment; Ancillary studies; Other Name: Quality of Life Assessment
Experimental: Arm II (cognitive intervention-CBT-I); 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.	Other: Cognitive Intervention; Undergo CBT-I intervention; Other: Laboratory Biomarker Analysis; Correlative studies; Device: Monitoring Device; Correlative studies; Other Name: Monitor; Other: Quality-of-Life Assessment; Ancillary studies; Other Name: Quality of Life Assessment
Active Comparator: Arm III (educational intervention); 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."	Other: Educational Intervention; Receive health education; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Other: Laboratory Biomarker Analysis; Correlative studies; Device: Monitoring Device; Correlative studies; Other Name: Monitor; Other: Quality-of-Life Assessment; Ancillary studies; Other Name: Quality of Life Assessment

Outcome Measures

Primary Outcome Measures :

1. Mean Change in the ISI Comparing YOCAS vs. CBT-I [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
   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.
2. Mean Change in the ISI Comparing YOCAS vs. Health Education [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
   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.

Secondary Outcome Measures :

1. Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. Health Education [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
   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.
2. Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. CBT-I. [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
   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.
3. Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. Health Education [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
   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.
4. Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. CBT-I [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
   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.
5. Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. Health Education [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
   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.
6. Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. CBT-I [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
   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.
7. Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. Health Education [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
   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.
8. Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. CBT-I [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
   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.
9. Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. Health Education [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
   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.
10. Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. CBT-I [ Time Frame: Baseline up to post intervention (approximately 4 to 8 weeks) ]
    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.
11. Mean Change in the ISI Comparing YOCAS and Health Education (3 Month) [ Time Frame: Baseline to 3 months ]
    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.
12. Mean Change in the ISI Comparing YOCAS and CBT-I (3 Month) [ Time Frame: Baseline to 3 months ]
    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.
13. Mean Change in the ISI Comparing YOCAS and Health Education (6 Month) [ Time Frame: Baseline to 6 months ]
    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.
14. Mean Change in the ISI Comparing YOCAS and CBT-I (6 Month) [ Time Frame: Baseline to 6 months ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Hawaii

Hawaii MU NCORP

Honolulu, Hawaii, United States, 96813

United States, Illinois

Heartland NCORP

Decatur, Illinois, United States, 62526

United States, Kansas

Wichita NCORP

Wichita, Kansas, United States, 67214

United States, Louisiana

Gulf South MU-NCORP

New Orleans, Louisiana, United States, 70112

United States, Michigan

Michigan Cancer Research Consortium NCORP

Ann Arbor, Michigan, United States, 48106

Cancer Research Consortium of West Michigan

Grand Rapids, Michigan, United States, 49503

United States, Minnesota

Metro-Minnesota NCORP

Minneapolis, Minnesota, United States, 55426

United States, Nevada

Nevada Cancer Research Foundation NCORP

Las Vegas, Nevada, United States, 89106

United States, New York

University of Rochester NCORP Research Base

Rochester, New York, United States, 14642

United States, North Carolina

Southeast Clinical Oncology Research Consortium

Winston-Salem, North Carolina, United States, 27104

United States, Ohio

Columbus NCORP

Columbus, Ohio, United States, 43215

Dayton Clinical Oncology Program

Dayton, Ohio, United States, 45420

United States, Oregon

Pacific Cancer Research Consortium Ncorp

Portland, Oregon, United States, 97213

United States, South Carolina

Greenville Health System NCORP

Greenville, South Carolina, United States, 29605

United States, Wisconsin

Wisconsin NCORP

Marshfield, Wisconsin, United States, 54449

Aurora NCORP

Milwaukee, Wisconsin, United States, 53226

Sponsors and Collaborators

University of Rochester NCORP Research Base

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Karen Mustian; University of Rochester NCORP Research Base

  Study Documents (Full-Text)

Documents provided by Karen Mustian, University of Rochester NCORP Research Base:

Study Protocol and Statistical Analysis Plan  [PDF] June 7, 2018

More Information

• Responsible Party: Karen Mustian, Professor, University of Rochester NCORP Research Base
• ClinicalTrials.gov Identifier: NCT02613364
• Other Study ID Numbers: URCC14040; NCI-2015-01144 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); RSRB052271 ( Other Identifier: University of Rochester ); URCC14040 ( Other Identifier: University of Rochester NCORP Research Base ); URCC-14040 ( Other Identifier: DCP ); URCC-14040 ( Other Identifier: CTEP ); R01CA181064 ( U.S. NIH Grant/Contract ); UG1CA189961 ( U.S. NIH Grant/Contract )
• First Posted: November 24, 2015
• Results First Posted: March 23, 2021
• Last Update Posted: May 1, 2024
• Last Verified: April 2024

Additional relevant MeSH terms:

Neoplasms; Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders