Effects of Tibetan Yoga on Fatigue and Sleep in Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00507923
First received: July 25, 2007
Last updated: September 14, 2012
Last verified: September 2012
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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:
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
4 sessions of yoga over 12 weeks.
|
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
4 sessions of simple stretching exercises for 12 weeks. Each session lasting 90 minutes.
|
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.
|
|
Usual Care
Option of participating in the Tibetan yoga program after completion of the study.
|
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
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: | NCT00507923 History of Changes |
| Other Study ID Numbers: | 2005-0035 |
| Study First Received: | July 25, 2007 |
| Last Updated: | September 14, 2012 |
| 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 June 18, 2013