CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 746 enrolled
Drug / intervention
Behavioral Intervention +5 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02613364
NCT02613364N/ACompleted

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

University of Rochester NCORP Research Base·interventional·Posted Nov 24, 2015·Updated May 1, 2024

In Brief

A clinical study evaluating Behavioral Intervention, Cognitive Intervention, and 4 other interventions for Cancer Survivor and 2 related conditions. Completed, enrolled 746 participants across 16 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedNov 24, 2015
Enrollment StartAug 31, 2016
Primary CompletionFeb 4, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.6 years ago

Interventions

Behavioral Interventionbehavioral

Undergo yoga intervention

Cognitive Interventionother

Undergo CBT-I intervention

Educational Interventionother

Receive health education

Laboratory Biomarker Analysisother

Correlative studies

Monitoring Devicedevice

Correlative studies

Quality-of-Life Assessmentother

Ancillary studies