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Study Summary
No. 2005-0522:.......Breast......Lorenzo Cohen......Behavioral Science
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Study Summary Title
Study Summary
Number:		2005-0522
Study Title:Biobehavioral Effects of Yoga During Breast Cancer Treatment
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Physician New Patient Referral
Name:Lorenzo CohenPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Behavioral ScienceReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-0919
Contact us about clinical trials
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General Information
Disease Group:BreastSupported By:N/A
Phase of Study:N/AReturn
Visit:		Intervention and assessments will be scheduled around the patients' projected
time of treatment and follow-up visits as per current MDACC care plan.
Treatment
Agents:		PsychosocialHome Care:NA
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		NA
Description/
Intervention:		The goal of this behavioral research study is to find out if patients will
enjoy and benefit from participation in a yoga program. Researchers want to see
if yoga will help to improve patients' quality of life (QOL) during treatment
for cancer and during recovery from the effects of cancer treatment.
Researchers want to learn if a yoga program is effective in helping to decrease
emotional distress and improve physiological functioning.
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Study Objectives / Outcomes
In this study we will examine the initial efficacy of implementing a yoga program for patients with breast cancer as an adjuvant to their radiotherapy. Patients with breast cancer who are undergoing radiotherapy will be randomly assigned to either a yoga group (YG), or a stretching (ST) control group, or a waitlist control (WL) group. Participants in YG and ST groups will attend three sessions each week throughout their 6-week radiotherapy schedule. The sessions will be coordinated with the treatment schedule and conducted adjacent to the treatment facility. Measures will be obtained prior to randomization, a brief assessment during the middle of radiation therapy, during the last week of radiation therapy, and 1, 3 and 6 months after the last radiation session. With the inclusion of two control groups in this randomized trial we will attempt to validate the benefits of yoga as an adjuvant to radiotherapy in patients with breast cancer wherein we will control for specific components of the yoga program and also examine some of the mechanisms that are necessary for the program to be effective. Our specific aims in the proposed study are to:

1. Conduct an initial evaluation of whether participation in the yoga program improves patients' fatigue and sleep disturbances. Fatigue and sleep will be assessed with self-report measures and the use of actigraphy for a more objective measure of sleep quality.
    2. Secondary end points will include examining QOL, mental health and objective physiological outcomes (blood samples for immune measures, saliva samples for cortisol levels, and heart rate variability).

    3. Exploratory analyses will examine some plausible mediators of the yoga program including cognitive processing, spirituality, and finding meaning in the cancer experience.
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    Study Status Information
    Study Activation / Registration Date:03/09/2006
    IRB Review and Approval Date:12/09/2005
    Study Type:Behavioral
    Recruitment Status:Closed
    Projected Accrual:N/A
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    Enrollment Eligibility
    If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
    Inclusion Criteria:1) Women with Stage 0 - III breast cancer, undergoing daily adjuvant radiation for 6 weeks in the Department of Radiation Oncology at the M. D. Anderson

    2) The participants will need to be 18 years of age or older.

    3) Patients should be able to read, write, and speak English or Spanish.
    Exclusion Criteria:1) Patients who have a documented diagnosis of a formal thought disorder (e.g., schizophrenia) will be excluded from the study.

    2) Patients with metastatic disease of the bone will be excluded to avoid any bone fractures that may result from yoga movements.

    3) Patients with active/non-canalized deep vein thrombosis will be excluded from the study.

    4) Patients who have not undergone any surgical treatment for their cancer will be excluded to ensure a more homogeneous sample.

    5) Patients with extreme mobility issues (e.g., unable to get in and out of a chair unassisted) will be excluded.

    6) Patients who have practiced yoga or taken yoga classes in the year prior to diagnosis will be excluded.

    7) Patients diagnosed with lymphedema at baseline will be excluded.
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    Links
    Registration Number: NCT00508794
    Study Information on Clinical Trials Registry (clinicaltrials.gov)
    Other Links:
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    Results

    Return to Clinical Trials at M.D. Anderson Cancer Center