Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy in Reducing Insomnia in Cancer Survivors
NCT ID: NCT02613364
Last Updated: 2024-05-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
746 participants
INTERVENTIONAL
2016-08-31
2020-02-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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 Intervention
Undergo yoga intervention
Laboratory Biomarker Analysis
Correlative studies
Monitoring Device
Correlative studies
Quality-of-Life Assessment
Ancillary studies
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.
Cognitive Intervention
Undergo CBT-I intervention
Laboratory Biomarker Analysis
Correlative studies
Monitoring Device
Correlative studies
Quality-of-Life Assessment
Ancillary studies
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."
Educational Intervention
Receive health education
Laboratory Biomarker Analysis
Correlative studies
Monitoring Device
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Interventions
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Behavioral Intervention
Undergo yoga intervention
Cognitive Intervention
Undergo CBT-I intervention
Educational Intervention
Receive health education
Laboratory Biomarker Analysis
Correlative studies
Monitoring Device
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Rochester NCORP Research Base
OTHER
Responsible Party
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Karen Mustian
Professor
Principal Investigators
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Karen Mustian
Role: PRINCIPAL_INVESTIGATOR
University of Rochester NCORP Research Base
Locations
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Hawaii MU NCORP
Honolulu, Hawaii, United States
Heartland NCORP
Decatur, Illinois, United States
Wichita NCORP
Wichita, Kansas, United States
Gulf South MU-NCORP
New Orleans, Louisiana, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States
Cancer Research Consortium of West Michigan
Grand Rapids, Michigan, United States
Metro-Minnesota NCORP
Minneapolis, Minnesota, United States
Nevada Cancer Research Foundation NCORP
Las Vegas, Nevada, United States
University of Rochester NCORP Research Base
Rochester, New York, United States
Southeast Clinical Oncology Research Consortium
Winston-Salem, North Carolina, United States
Columbus NCORP
Columbus, Ohio, United States
Dayton Clinical Oncology Program
Dayton, Ohio, United States
Pacific Cancer Research Consortium Ncorp
Portland, Oregon, United States
Greenville Health System NCORP
Greenville, South Carolina, United States
Wisconsin NCORP
Marshfield, Wisconsin, United States
Aurora NCORP
Milwaukee, Wisconsin, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2015-01144
Identifier Type: REGISTRY
Identifier Source: secondary_id
RSRB052271
Identifier Type: OTHER
Identifier Source: secondary_id
URCC14040
Identifier Type: OTHER
Identifier Source: secondary_id
URCC-14040
Identifier Type: OTHER
Identifier Source: secondary_id
URCC-14040
Identifier Type: OTHER
Identifier Source: secondary_id
URCC14040
Identifier Type: -
Identifier Source: org_study_id
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