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NCT02613364 · ClinicalTrials.gov registry record · NA
Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy in Reducing Insomnia in Cancer Survivors
A NA study of Insomnia and Malignant Neoplasm, sponsored by University of Rochester NCORP Research Base.
- Completed
- Registry status
- NA
- Development phase
- 746
- Enrollment target
- 16
- Study locations
NCT02613364: Completed NA study of Insomnia and Malignant Neoplasm, sponsored by University of Rochester NCORP Research Base.
NCT02613364 is a NA study of Insomnia and Malignant Neoplasm that has completed, run by University of Rochester NCORP Research Base. The registered enrollment target is 746 participants, above the 165-participant average among 151 other Insomnia trials with a reported enrollment target (352% higher). The trial reports 16 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02613364, a NA study of Insomnia and Malignant Neoplasm, has completed, sponsored by University of Rochester NCORP Research Base.
- COMPLETED
- Registry status
- NA
- Development phase
- 746 participants
- Enrollment target
- 16
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- OTHER Educational Intervention
- BEHAVIORAL Behavioral Intervention
- OTHER Cognitive Intervention
- DEVICE Monitoring Device
Study Locations (16)
Michigan
- Michigan Cancer Research Consortium NCORP - Ann Arbor
- Cancer Research Consortium of West Michigan - Grand Rapids
Ohio
- Columbus NCORP - Columbus
- Dayton Clinical Oncology Program - Dayton
Wisconsin
- Wisconsin NCORP - Marshfield
- Aurora NCORP - Milwaukee
Hawaii
- Hawaii MU NCORP - Honolulu
Illinois
- Heartland NCORP - Decatur
Kansas
- Wichita NCORP - Wichita
Louisiana
- Gulf South MU-NCORP - New Orleans
Minnesota
- Metro-Minnesota NCORP - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 746 participants |
| Start Date | 2016-08-31 |
| Est. Completion | 2020-02-04 |
| Phase | NA |
What the finished NCT02613364 record still lists
NCT02613364 is an interventional study that assigns participants to a tested intervention. The registered 746 participants enrollment target is mid-sized for trials with a published cap, above the 165-participant average among 151 other Insomnia trials with a reported enrollment target (352% higher).
The record links to 3 conditions, with Insomnia appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02613364 lists 16 locations in 13 states (Michigan, Ohio, Wisconsin).
Frequently Asked Questions
What is clinical trial NCT02613364 about?
NCT02613364 is a clinical study titled "Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy in Reducing Insomnia in Cancer Survivors". 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...
What is the current status of trial NCT02613364?
This trial is currently completed. It is a NA study. The enrollment target is 746 participants. The study started on 2016-08-31. Estimated completion is 2020-02-04.
What conditions does trial NCT02613364 study?
This clinical trial studies the following conditions: Insomnia, Malignant Neoplasm, Cancer Survivor.
What interventions are being tested in trial NCT02613364?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Educational Intervention (OTHER), Behavioral Intervention (BEHAVIORAL), Cognitive Intervention (OTHER), Monitoring Device (DEVICE).
Who is sponsoring clinical trial NCT02613364?
This trial is sponsored by University of Rochester NCORP Research Base, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02613364 being conducted?
This trial has 16 study locations across Hawaii, Illinois, Kansas, Louisiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02613364's enrollment target sits among peer trials
746 6th of 151 higher than 146 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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