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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006346
First received: October 4, 2000
Last updated: May 21, 2013
Last verified: March 2010
History of Changes
  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 of Cancer and Its Treatment
 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2000
Study Completion Date: September 2003
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006346

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
Sponsors and Collaborators
St. Joseph Hospital Health Center
Investigators
Study Chair: Rhoda S. Pomerantz, MD, MPH St. Joseph Hospital Health Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00006346     History of Changes
Other Study ID Numbers: SJHCH-TM1, CDR0000068177, NCI-V00-1618
Study First Received: October 4, 2000
Last Updated: May 21, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II breast cancer
stage IV breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
psychosocial effects of cancer and its treatment

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 22, 2013