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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006346
Recruitment Status : Completed
First Posted : September 4, 2003
Last Update Posted : July 10, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 or disease Intervention/treatment Phase
Breast Cancer Psychosocial Effects of Cancer and Its Treatment Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Not Applicable

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
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
Actual Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Diagnosis of stage II, III, or IV breast cancer
  • No brain or CNS metastases
  • Hormone receptor status:

    • Not specified



  • 55 and over


  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • More than 3 months


  • Not specified


  • Not specified


  • Not specified


  • No non-cancer life-threatening illness
  • No history of major psychiatric disorders
  • No drug abuse dependency disorder


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • Not specified


  • Not specified


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00006346

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
Study Chair: Rhoda S. Pomerantz, MD, MPH St. Joseph Hospital Health Center

Publications of Results: Identifier: NCT00006346     History of Changes
Other Study ID Numbers: SJHCH-TM1
CDR0000068177 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: September 4, 2003    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: March 2010

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
Breast Diseases
Skin Diseases