Stress Reduction For Breast Cancer in Women 55 Years of Age or Older: Enhancing Quality of Life and Survival
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 6
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of stage II, III, or IV breast cancer
- •No brain or CNS metastases
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •55 and over
- •Menopausal status:
- •Not specified
- •Performance status:
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •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
- •Not specified
排除标准
- 未提供