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| Sponsored by: |
St. Joseph Hospital |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006346 |
Purpose
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 | Intervention |
|---|---|
|
Breast Cancer Psychosocial Effects/Treatment Quality of Life |
Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
| Study Type: | Interventional |
| 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 |
OBJECTIVES:
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.
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.
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.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Illinois | |
| St. Joseph Hospital | |
| Chicago, Illinois, United States, 60657 | |
| United States, Indiana | |
| Hope Center | |
| 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 |
More Information
| Study ID Numbers: | CDR0000068177, SJHCH-TM1, NCI-V00-1618 |
| Study First Received: | October 4, 2000 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006346 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II breast cancer stage IV breast cancer stage IIIA breast cancer |
stage IIIB breast cancer psychosocial effects/treatment quality of life |
|
Skin Diseases Quality of Life Stress Breast Neoplasms Breast Diseases |
|
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |