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NCT Number: NCT00397930

Yoga in Treating Sleep Disturbance in Cancer Survivors

RATIONALE: Yoga may help improve sleep, fatigue, and quality of life in cancer survivors.

PURPOSE: This phase II trial is studying how well yoga works in treating sleep disturbance in cancer survivors.

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Key information

Conditions

Fatigue Cancer Mental Disorders Neoplasms Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders Sleep Wake Disorders

Age range

21 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CCOP - Central Illinois, Decatur, Illinois, United States

Loading trial locations.

About this study

OBJECTIVES:

Primary

  • Determine the efficacy of Hatha yoga in improving sleep quality in cancer survivors experiencing persistent sleep disturbance.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to gender and sleep disturbance rating reported on the eligibility assessment questionnaire (≤ 5 vs > 5). Patients are randomized to 1 of 2 arms.

  • Arm I: Patients receive standard care for 6 weeks. Patients may switch to the yoga intervention immediately after study completion.
  • Arm II:Patients receive standard care for 2 weeks, followed by two 75-minute sessions of Hatha yoga per week for 4 weeks.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of any type of cancer
  • More than 1 primary cancer allowed
  • Has undergone and completed all forms of standard treatment (surgery, chemotherapy, radiation therapy) within the past 2 to 24 months
  • Patients can be on hormones such as Tamoxifen, or monoclonal antibodies like Herceptin
  • Persistent sleep disturbance, as indicated by a response of ≥ 3 when asked to rate their sleep on an 11-point scale (0 is equivalent to no sleep disturbance and 10 is the worst possible sleep disturbance)
  • Able to read English
  • 21 years of age or older

Exclusion criteria

  • No prior or concurrent regular (≥ 1 day/week) participation in yoga classes or maintain regular personal practice of any form of yoga within the past 3 months
  • No diagnosis of sleep apnea
  • No concurrent cancer therapy with the exception of hormonal therapy (e.g., tamoxifen citrate) or monoclonal antibodies (e.g., trastuzumab [Herceptin®])
  • No metastatic cancer

Treatment and study plan

Standard Care Control Condition

Procedure

Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.

Yoga Intervention (YOCAS)

Procedure

The Yoga for Cancer Survivors (YOCAS) intervention uses two forms of yoga: Gentle Hatha yoga and Restorative yoga. The YOCAS sessions are standardized, and each session includes physical alignment postures, breathing and mindfulness exercises. The intervention is delivered in an instructor taught, group format, twice a week for 75 minutes each time over 4 weeks for a total of eight sessions of yoga. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.

Primary outcomes

  1. Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI)

    Time frame: 2-24 months after surgery, chemotherapy, and/or radiation therapy

    Pittsburgh Sleep Quality Index: Measures sleep disturbance and usual sleep habits during the prior month only using seven clinically derived domains of sleep difficulties: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. Global PSQI is a summary of the seven domains. Each Domain is scored from 0 to 3, therefore PSQI has a range of 0 (better) to 21 (worse). Interpretation of the PSQI is that a score less than 5 is associated with good sleep quality and a score of 5 or greater is associated with poor sleep quality.

    PSQI was calculated at both pre- and post-intervention for both arms. Pre-intervention PSQI was recorded during the week immediately before commencing the 4-week intervention. Post-intervention PSQI was recorded during the week immediately following the intervention. Mean post-pre change was calculated for both arms.

Sponsors and collaborators

Lead sponsor

Gary Morrow

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Yoga for Persistent Sleep Disturbance in Cancer Survivors

Acronym: YOCAS

Important dates

Study start
2006
Primary completion
2013
Study completion
2013
First posted
Nov 10, 2006
Registry last updated
Feb 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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