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

NCT02613364 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 746

Last updated 2024-05-01

Study results available
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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

Interventions

BEHAVIORAL

Behavioral Intervention

Undergo yoga intervention

OTHER

Cognitive Intervention

Undergo CBT-I intervention

OTHER

Educational Intervention

Receive health education

OTHER

Laboratory Biomarker Analysis

Correlative studies

DEVICE

Monitoring Device

Correlative studies

OTHER

Quality-of-Life Assessment

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Rochester NCORP Research Base

    lead OTHER

Principal Investigators

  • Karen Mustian · University of Rochester NCORP Research Base

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2020-02-04
Completion
2020-02-04

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02613364 on ClinicalTrials.gov