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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 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.

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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.

Conditions Studied

Insomnia Malignant Neoplasm Cancer Survivor

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

FieldValue
Enrollment Target 746 participants
Start Date 2016-08-31
Est. Completion 2020-02-04
Phase NA

Sponsor

University of Rochester NCORP Research Base

11 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02613364

The ClinicalTrials.gov registry entry for NCT02613364 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 746 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 165-participant average among 151 other Insomnia trials with a reported enrollment target (352% higher). The listed sponsor is University of Rochester NCORP Research Base, which has 11 total studies on file at ClinicalTrials.gov.

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 reports 16 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.