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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborators: |
National Institutes of Health (NIH) National Cancer Institute (NCI) |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00508794 |
Purpose
In this study researchers 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 researchers will attempt to validate the benefits of yoga as an adjuvant to radiotherapy in patients with breast cancer wherein researchers 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:
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Behavioral: Yoga Group Behavioral: Stretching Control Group Behavioral: Waitlist Control Group Other: Questionnaire |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Biobehavioral Effects of Yoga During Breast Cancer Treatment |
| Estimated Enrollment: | 180 |
| Study Start Date: | March 2006 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Yoga Program
|
Behavioral: Yoga Group
3 sessions of yoga each week for 6 weeks.
Other: Questionnaire
Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy.
|
|
2: Experimental
Stretching Program
|
Behavioral: Stretching Control Group
3 sessions of stretching each week for 6 weeks
Other: Questionnaire
Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy.
|
|
3: No Intervention
Waitlist Control Group
|
Behavioral: Waitlist Control Group
Option of participating in the yoga or stretching program after the study has ended.
Other: Questionnaire
Questionnaire evaluating treatment-related symptoms during the middle of radiotherapy.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| U.T.M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Lorenzo Cohen, PhD | U.T.M.D. Anderson Cancer Center |
More Information
| Responsible Party: | U.T.M.D. Anderson Cancer Center ( Lorenzo Cohen, PhD/Professor ) |
| Study ID Numbers: | 2005-0522 |
| Study First Received: | July 27, 2007 |
| Last Updated: | June 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00508794 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Breast Cancer Tibetan Yoga Stretching Program Yoga |
Quality of Life Questionnaire Survey |
|
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |