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Stress Reduction in Older Women With Stage II, Stage III, or Stage IV Breast Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Stress Reduction in Older Women With Stage II, Stage III, or Stage IV Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Stress Reduction in Older Women With Stage II, Stage III, or Stage IV Breast Cancer Clinical research trials and Stress Reduction in Older Women With Stage II, Stage III, or Stage IV Breast Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Stress Reduction in Older Women With Stage II, Stage III, or Stage IV Breast Cancer. Stress Reduction in Older Women With Stage II, Stage III, or Stage IV Breast Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Stress Reduction in Older Women With Stage II, Stage III, or Stage IV Breast Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Stress Reduction in Older Women With Stage II, Stage III, or Stage IV Breast Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Stress Reduction in Older Women With Stage II, Stage III, or Stage IV Breast Cancer  Stress Reduction in Older Women With Stage II, Stage III, or Stage IV Breast Cancer
Stress Reduction in Older Women With Stage II, Stage III, or Stage IV Breast Cancer
For Condition: stage 2 breast cancer,Quality of Life,stage 3A breast cancer,stage 3B breast cancer,psychosocial effects/treatment,stage 4 breast cancer
Status: Completed
Sponsor(s): St. Joseph Hospital ,
Synopsis: 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: Randomized clinical trial to compare the effectiveness of transcendental meditation with that of basic breast cancer education in improving quality of life in women who have stage II, stage III, or stage IV breast cancer.
Details: OBJECTIVES: I. 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. II. Determine behavioral mechanisms that may mediate the effects of stress reduction on survival in these patients. III. Determine baseline variables that contribute to predicting survival time in these patients. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 55 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of stage II, III, or IV breast cancer - No brain or CNS metastases - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Not specified - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RhodaPomerantz, Study Chair, St. Joseph Hospital
Maharishi International University
Fairfield, Iowa, 52557
United States
St. Joseph Hospital
Chicago, Illinois, 60657
United States
Hope Center
Terre Haute, Indiana, 47809
United States
Additional Information:
Study ID Numbers: CDR0000068177; NCI-V00-1618,SJHCH-TM1
Study Start Date: August 2000
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006346
Other Stage 2 Breast Cancer Studies:
1. Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer
2. EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer
3. Nipple Aspiration, Ductal Lavage, and Duct Endoscopy For Diagnostic Assessment in Women Undergoing Surgery for Breast Cancer
4. Gene Therapy Plus Chemotherapy in Treating Patients With Breast Cancer
5. Combination Chemotherapy Following Surgery in Treating Women With Early Stage Breast Cancer
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Stress Reduction in Older Women With Stage II, Stage III, or Stage IV Breast Cancer
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