Effects of Tibetan Yoga on Fatigue and Sleep in Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00507923
First received: July 25, 2007
Last updated: September 17, 2014
Last verified: September 2014
  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 2016 (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:

  1. 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).
  2. 18 years of age or older.
  3. Able to read, write and speak English
  4. Able to come to UTMDACC for intervention and assessment sessions.

Exclusion Criteria:

  1. Metastatic disease of the bone.
  2. Documented diagnosis of a formal thought disorder (e.g., schizophrenia).
  3. Engaged in psychiatric or psychological counseling or support groups.
  4. Reports the need for psychological services.
  5. Score of 23 or below on the Mini-Mental State Examination.
  6. Presence of lymphedema at the start of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
University of Texas 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, 1 R01 CA105023-01 A1
Study First Received: July 25, 2007
Last Updated: September 17, 2014
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
Breast Diseases
Neoplasms
Neoplasms by Site
Signs and Symptoms
Skin Diseases

ClinicalTrials.gov processed this record on October 22, 2014