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

NCT02613364 | Completed Results DMC

• 6 other identifiers: URCC14040NCI-2015-01144RSRB052271URCC-14040R01CA181064UG1CA189961
• Study Type: interventional
• Target: 746
• Locations: 1 country
• Sites: 16

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.

Conditions

Cancer Survivor; Insomnia; Malignant Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (14)

• Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. Health Education

  Baseline up to post intervention (approximately 4 to 8 weeks)

• Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. CBT-I.

  Baseline up to post intervention (approximately 4 to 8 weeks)

• Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. Health Education

  Baseline up to post intervention (approximately 4 to 8 weeks)

• Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. CBT-I

  Baseline up to post intervention (approximately 4 to 8 weeks)

• Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. Health Education

  Baseline up to post intervention (approximately 4 to 8 weeks)

Study Arms (3)

Arm I (behavioral intervention-yoga)

EXPERIMENTAL

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; Other: Laboratory Biomarker Analysis; Device: Monitoring Device; Other: Quality-of-Life Assessment

Arm II (cognitive intervention-CBT-I)

EXPERIMENTAL

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; Other: Laboratory Biomarker Analysis; Device: Monitoring Device; Other: Quality-of-Life Assessment

Arm III (educational intervention)

ACTIVE COMPARATOR

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; Other: Laboratory Biomarker Analysis; Device: Monitoring Device; Other: Quality-of-Life Assessment

Interventions

Behavioral Intervention BEHAVIORAL

Undergo yoga intervention

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, BEHAVIORAL THERAPY, Behavioral Treatment, Behavioral Treatments

Arm I (behavioral intervention-yoga)

Cognitive Intervention OTHER

Undergo CBT-I intervention

Arm II (cognitive intervention-CBT-I)

Educational Intervention OTHER

Receive health education

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm III (educational intervention)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (behavioral intervention-yoga); Arm II (cognitive intervention-CBT-I); Arm III (educational intervention)

Monitoring Device DEVICE

Correlative studies

Also known as: Monitor

Arm I (behavioral intervention-yoga); Arm II (cognitive intervention-CBT-I); Arm III (educational intervention)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (behavioral intervention-yoga); Arm II (cognitive intervention-CBT-I); Arm III (educational intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester NCORP Research Base: lead
• National Cancer Institute (NCI): collaborator

Study Sites (16)

Hawaii MU NCORP

Honolulu, Hawaii, 96813, United States

Location

Heartland NCORP

Decatur, Illinois, 62526, United States

Location

Wichita NCORP

Wichita, Kansas, 67214, United States

Location

Gulf South MU-NCORP

New Orleans, Louisiana, 70112, United States

Location

Michigan Cancer Research Consortium NCORP

Ann Arbor, Michigan, 48106, United States

Location

Cancer Research Consortium of West Michigan

Grand Rapids, Michigan, 49503, United States

Location

Metro-Minnesota NCORP

Minneapolis, Minnesota, 55426, United States

Location

Nevada Cancer Research Foundation NCORP

Las Vegas, Nevada, 89106, United States

Location

University of Rochester NCORP Research Base

Rochester, New York, 14642, United States

Location

Southeast Clinical Oncology Research Consortium

Winston-Salem, North Carolina, 27104, United States

Location

Columbus NCORP

Columbus, Ohio, 43215, United States

Location

Dayton Clinical Oncology Program

Dayton, Ohio, 45420, United States

Location

Pacific Cancer Research Consortium Ncorp

Portland, Oregon, 97213, United States

Location

Greenville Health System NCORP

Greenville, South Carolina, 29605, United States

Location

Wisconsin NCORP

Marshfield, Wisconsin, 54449, United States

Location

Aurora NCORP

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (2)

• Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.

  PMID: 41170811 DERIVED

• Altman BJ, Lin PJ, Mattick LJ, Outland EH, Bautista J, Li CS, Gada U, Morris KM, Knudsen-Clark AM, Mwangi D, DeRollo RE, Kleckner AS, Kleckner IR, Gilmore NJ, Esparaz BT, Curtis A, Conlin A, Monaco G, Hughey JJ, Mustian KM. Blood Clock Correlation Distance (BloodCCD) as a novel marker to detect circadian rhythm disruption in cancer survivors with insomnia. BJC Rep. 2025 Sep 3;3(1):60. doi: 10.1038/s44276-025-00176-9.

  PMID: 40903493 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Neoplasms

Interventions

Behavior Therapy; Early Intervention, Educational; Educational Status; Methods; Monitoring, Physiologic

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Dr. Karen Mustian, Study PI
• Organization: University of Rochester Medical Center

karen_mustian@urmc.rochester.edu

585-275-0557

Study Officials

• Karen Mustian

  University of Rochester NCORP Research Base

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: November 24, 2015
• Study Start: August 31, 2016
• Primary Completion: February 4, 2020
• Study Completion: February 4, 2020
• Last Updated: May 1, 2024
• Results First Posted: March 23, 2021

Record last verified: 2024-04

Locations

US (16)