Effects of Yoga in Breast Cancer Patients
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Collaborators:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00508794
First received: July 27, 2007
Last updated: November 11, 2011
Last verified: November 2011
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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:
- 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.
- 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).
- Exploratory analyses will examine some plausible mediators of the yoga program including cognitive processing, spirituality, and finding meaning in the cancer experience.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Behavioral: Yoga Group Behavioral: Stretching Control Group Behavioral: Waitlist Control Group Other: Questionnaire |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Biobehavioral Effects of Yoga During Breast Cancer Treatment |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Fatigue and sleep assessed with self-report measures and actigraphy. [ Time Frame: 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. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]
- To learn if a yoga program is effective in helping to decrease emotional distress and improve physiological functioning. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 180 |
| Study Start Date: | March 2006 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group 1 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.
Other Name: Survey
|
| Experimental: Group 2 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.
Other Name: Survey
|
| No Intervention: Group 3 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.
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 0 - III breast cancer, undergoing daily adjuvant radiation for 6 weeks in the Department of Radiation Oncology at the M. D. Anderson.
- The participants will need to be 18 years of age or older.
- Patients should be able to read, write, and speak English or Spanish.
Exclusion Criteria:
- Patients who have a documented diagnosis of a formal thought disorder (e.g., schizophrenia) will be excluded from the study.
- Patients with metastatic disease of the bone will be excluded to avoid any bone fractures that may result from yoga movements.
- Patients with active/non-canalized deep vein thrombosis will be excluded from the study.
- Patients who have not undergone any surgical treatment for their cancer will be excluded to ensure a more homogeneous sample.
- Patients with extreme mobility issues (e.g., unable to get in and out of a chair unassisted) will be excluded.
- Patients who have practiced yoga or taken yoga classes in the year prior to diagnosis will be excluded.
- Patients diagnosed with lymphedema at baseline will be excluded.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00508794
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Lorenzo Cohen, PhD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00508794 History of Changes |
| Other Study ID Numbers: | 2005-0522 |
| Study First Received: | July 27, 2007 |
| Last Updated: | November 11, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Breast Cancer Tibetan Yoga Stretching Program Yoga |
Quality of Life Questionnaire Survey |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on October 17, 2012
