Effects of Tibetan Yoga on Fatigue and Sleep in Cancer - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00507923

Purpose

The goal of this behavioral research study is to learn if participating in a Tibetan yoga program helps to improve quality of life for women during treatment for or recovery from breast cancer. Researchers are also interested in whether the yoga program helps to improve sleep, lung function, and physical therapy, based on outcomes.

Condition	Intervention
Breast Cancer	Behavioral: Tibetan Yoga Behavioral: Stretching Program Other: No Intervention Behavioral: Questionnaire Behavioral: Booster Program

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Effects of Tibetan Yoga on Fatigue and Sleep in Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Fatigue

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

Assessments of Fatigue [ Time Frame: 1 month assessment ] [ Designated as safety issue: No ]

Estimated Enrollment:	480
Study Start Date:	November 2006
Estimated Primary Completion Date:	November 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Tibetan Yoga Program	Behavioral: Tibetan Yoga 4 sessions of yoga over 12 weeks. Behavioral: Questionnaire Questionnaires to be completed before and after the end of the yoga or stretching sessions (or similar time for the usual care group). Other Name: Survey Behavioral: Booster Program 3 "booster" sessions consisting of a review and practice of the entire program.
Experimental: Stretching Group	Behavioral: Stretching Program 4 sessions of simple stretching exercises for 12 weeks. Each session lasting 90 minutes. Other: No Intervention Option of participating in the Tibetan yoga program after completion of the study. Behavioral: Questionnaire Questionnaires to be completed before and after the end of the yoga or stretching sessions (or similar time for the usual care group). Other Name: Survey Behavioral: Booster Program 3 "booster" sessions consisting of a review and practice of the entire program.
No Intervention: Usual Care	Other: No Intervention Option of participating in the Tibetan yoga program after completion of the study. Behavioral: Questionnaire Questionnaires to be completed before and after the end of the yoga or stretching sessions (or similar time for the usual care group). Other Name: Survey

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women with stage I-III breast cancer who are undergoing neoadjuvant or adjuvant chemotherapy weekly for 12 weeks followed by four cycles of an anthracycline-based treatment every 21 days or six to eight cycles of chemotherapy every 21 days or are within 24 months post-treatment (surgery and/or chemotherapy and/or radiotherapy - patients can still be taking hormonal treatment).
18 years of age or older.
Able to read, write and speak English
Able to come to UTMDACC for intervention and assessment sessions.

Exclusion Criteria:

Metastatic disease of the bone.
Documented diagnosis of a formal thought disorder (e.g., schizophrenia).
Engaged in psychiatric or psychological counseling or support groups.
Reports the need for psychological services.
Score of 23 or below on the Mini-Mental State Examination.
Presence of lymphedema at the start of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507923

Contacts

Contact: Donna S. Capps, MA

713-792-1854

dscapps@mdanderson.org

Locations

United States, Texas
UT MD Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Lorenzo Cohen, PhD

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Lorenzo Cohen, PhD

M.D. Anderson Cancer Center

More Information

Additional Information:

UT MD Anderson Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00507923 History of Changes
Other Study ID Numbers:	2005-0035
Study First Received:	July 25, 2007
Last Updated:	December 30, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Breast Cancer
Tibetan Yoga
Stretching
Yoga

Fatigue
Sleep
Questionnaire
Survey

Additional relevant MeSH terms:

Breast Neoplasms
Fatigue
Neoplasms by Site
Neoplasms

Breast Diseases
Skin Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012