Stress Reduction in Older Women With Stage II, Stage III, or Stage IV Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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Stress Reduction For Breast Cancer in Women 55 Years of Age or Older: Enhancing Quality of Life and Survival

Conditions
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Breast Cancer, Psychosocial Effects of Cancer and Its Treatment

Intervention / Treatment
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* Procedure: psychosocial assessment and care
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of stage II, III, or IV breast cancer No brain or CNS metastases Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 55 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: More than 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No non-cancer life-threatening illness No history of major psychiatric disorders No drug abuse dependency disorder PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: psychosocial assessment and care|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II breast cancer, stage IV breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, psychosocial effects of cancer and its treatment