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Yoga for Persistent Sleep Disturbance in Cancer Survivors


Phase 2
21 Years
N/A
Not Enrolling
Both
Cancer Survivor, Fatigue, Psychosocial Effects of Cancer and Its Treatment, Sleep Disorders

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Trial Information

Yoga for Persistent Sleep Disturbance in Cancer Survivors


OBJECTIVES:

Primary

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

Secondary

- Determine the efficacy of yoga in improving fatigue and quality of life (QOL) of cancer
survivors.

- Determine if the positive effects of yoga on sleep are related to concurrent changes in
fatigue and QOL.

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.

All patients complete Pittsburgh Sleep Quality Inventory, Insomnia Severity Index,
Functional Assessment of Chronic Illness Therapy-Fatigue, Sleep Medication and Complementary
and Alternative Medicine Usage, Symptom Inventory, Multidimensional Fatigue Symptom
Inventory, Profile of Mood States, and Aerobic Center Longitudinal Study Physical Activity
questionnaires at baseline and at study completion. Patients also wear an actigraph (a
device worn on the wrist to measure activity level) for 1 week before and for 1 week after
completion of study intervention. Patients also complete daily diaries for the duration of
the study.

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

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of any type of cancer

- More than 1 primary cancer allowed

- No metastatic cancer

- Has undergone and completed all forms of standard treatment (surgery,
chemotherapy, radiation therapy) within the past 2 to 24 months

- 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)

- No diagnosis of sleep apnea

PATIENT CHARACTERISTICS:

- Able to read English

- 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

PRIOR CONCURRENT THERAPY:

- No concurrent cancer therapy with the exception of hormonal therapy (e.g., tamoxifen
citrate) or monoclonal antibodies (e.g., trastuzumab [Herceptin®])

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Outcome Measure:

Efficacy of Hatha yoga in improving sleep quality as measured by Pittsburgh Sleep Quality Inventory and Insomnia Severity Index

Safety Issue:

No

Principal Investigator

Karen M. Mustian, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester

Authority:

United States: Federal Government

Study ID:

CDR0000515123

NCT ID:

NCT00397930

Start Date:

October 2006

Completion Date:

April 2010

Related Keywords:

  • Cancer Survivor
  • Fatigue
  • Psychosocial Effects of Cancer and Its Treatment
  • Sleep Disorders
  • psychosocial effects of cancer and its treatment
  • fatigue
  • cancer survivor
  • sleep disorders
  • Fatigue
  • Sleep Disorders
  • Dyssomnias
  • Parasomnias

Name

Location

CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - ColumbusColumbus, Ohio  43206
CCOP - GreenvilleGreenville, South Carolina  29615
CCOP - Grand RapidsGrand Rapids, Michigan  49503
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - NorthwestTacoma, Washington  98405-0986
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057