Clinical trial NCT00006346: Stress Reduction in Older Women With Stage II, Stage III, or Stage IV Breast Cancer
Official title: Stress Reduction For Breast Cancer in Women 55 Years of Age or Older: Enhancing Quality of Life and Survival
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Psychosocial Effects of Cancer and Its Treatment
Keywords: stage II breast cancer
stage IV breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
psychosocial effects of cancer and its treatment
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-09-04
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: St. Joseph Hospital
state: Illinois
city: Terre Haute
country: United States
facility: Hope Center
state: Indiana
city: Fairfield
country: United States
facility: Maharishi International University
state: Iowa
Study officials:
affiliation: Unity Health Toronto
name: Rhoda S. Pomerantz, MD, MPH
role: STUDY_CHAIR
References:
citation: Nidich SI, Fields JZ, Rainforth MV, Pomerantz R, Cella D, Kristeller J, Salerno JW, Schneider RH. A randomized controlled trial of the effects of transcendental meditation on quality of life in older breast cancer patients. Integr Cancer Ther. 2009 Sep;8(3):228-34. doi: 10.1177/1534735409343000.