Stress Reduction in Older Women With Stage II, Stage III, or Stage IV Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00006346|
Recruitment Status : Completed
First Posted : September 4, 2003
Last Update Posted : July 10, 2013
RATIONALE: Transcendental meditation may be an effective way to decrease the amount of stress in older women with breast cancer. It is not yet known if transcendental meditation is more effective than basic breast cancer education in improving quality of life.
PURPOSE: This randomized clinical trialstudies stress reduction in improvingquality of life in older women with stage II, stage III, or stage IV breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Psychosocial Effects of Cancer and Its Treatment||Procedure: psychosocial assessment and care Procedure: quality-of-life assessment||Not Applicable|
- Compare the effects of active stress reduction with transcendental meditation vs basic breast cancer education on quality of life and survival time in older women with stage II, III, or IV breast cancer.
- Determine behavioral mechanisms that may mediate the effects of stress reduction on survival in these patients.
- Determine baseline variables that contribute to predicting survival time in these patients.
OUTLINE: This is a randomized, single blind (to medical staff), multicenter study. Patients are stratified according to age and participation in support groups. Patients with stage IV disease are also stratified according to type of metastases (visceral vs non-visceral) and timing of metastases (first diagnosis vs recurrence). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive usual medical care and instruction on stress reduction using transcendental meditation (TM), which involves a standard 7-step course. Patients attend training for approximately 1-1.5 hours per session for a total of 6 sessions over 1 week, while receiving usual medical care. Patients then practice TM twice a day for 20 minutes. Patients attend group meetings for approximately 90 minutes once or twice monthly for 6 months to ensure proper technique and understanding.
- Arm II: Patients receive usual medical care and basic literature on breast cancer.
Quality of life is assessed at baseline and then every 6 months for up to 3 years.
Patients are followed monthly for up to 2.5 years.
PROJECTED ACCRUAL: Approximately 166 patients (83 per treatment arm) will be accrued for this study within 6 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Stress Reduction For Breast Cancer in Women 55 Years of Age or Older: Enhancing Quality of Life and Survival|
|Study Start Date :||August 2000|
|Actual Study Completion Date :||September 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006346
|United States, Illinois|
|St. Joseph Hospital|
|Chicago, Illinois, United States, 60657|
|United States, Indiana|
|Terre Haute, Indiana, United States, 47809|
|United States, Iowa|
|Maharishi International University|
|Fairfield, Iowa, United States, 52557|
|Study Chair:||Rhoda S. Pomerantz, MD, MPH||St. Joseph Hospital Health Center|