Trial Information

Stress Reduction For Breast Cancer in Women 55 Years of Age or Older: Enhancing Quality of Life and Survival

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.