Expired Study
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Bethesda, Maryland 20892


Purpose:

RATIONALE: Physical activity may be effective in preventing the development or recurrence of breast cancer. PURPOSE: This randomized clinical trial is studying physical activity to see how well it works in preventing breast cancer in women with a history of breast cancer or who are at high risk for breast cancer who are not physically active.


Study summary:

OBJECTIVES: Primary - Compare the rate of compliance in sedentary women with a history of breast cancer or at high risk for breast cancer undergoing a physical activity intervention comprising walking using a pedometer vs stretching. - Compare the efficacy of these interventions, in terms of increased physical activity, in these patients. Secondary - Correlate physical activity, as measured by a pedometer, with self-report of exercise on the Modifiable Activity Questionnaire in patients undergoing the physical activity intervention. - Compare modulation of high-density lipoprotein, insulin-like growth factor I, estradiol, and c-reactive protein in patients undergoing these interventions. - Compare multidimensional quality of life in patients undergoing these interventions. - Correlate pedometer measurements of daily step counts with accelerometer measurements in patients undergoing the physical activity intervention. - Compare the functional capacity, as measured by the six-minute walk test, of patients undergoing these interventions. - Compare the body composition, as measured by anthropometry and bioelectrical impedance, of patients undergoing these interventions. - Determine if these three month physical activity intervention changes the long term physical activity behavior of patients as measured by a pedometer and a self report one year following the intervention. - Examine post-program exercise motivation and adherence of patients undergoing these interventions. OUTLINE: This is a randomized, pilot study. All patients wear pedometers for 1 week (without changing activity level) to assess activity level. Patients deemed sedentary are randomized to 1 of 2 arms. - Arm I (walking): Patients wear a pedometer daily for 12 weeks. Patients receive an exercise prescription outlining weekly step count goals and a motivational and educational pamphlet. - Arm II (stretching): Patients receive instruction on stretching exercises and keep a stretching exercise log book for 12 weeks. In both arms, intervention continues in the absence of injury or illness. Patients complete the Modifiable Activity Questionnaire at baseline and then at weeks 4, 8, and 12. Quality of life is assessed at baseline and then at week 12. PROJECTED ACCRUAL: A total of 175 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Meets criteria for 1 of the following: - History of stage I, II, or III invasive breast cancer - At least 2 months since completion of primary therapy, including surgery, radiotherapy, or chemotherapy - No metastatic or recurrent disease - At high risk for breast cancer, defined by meeting 1 of the following criteria: - Gail model risk ≥ 1.7% over 5 years OR Claus model lifetime risk of > 20% - Lobular neoplasia - Atypical ductal hyperplasia - Ductal carcinoma in situ that has been previously treated with mastectomy or lumpectomy and radiotherapy, with or without tamoxifen or an aromatase inhibitor - Deleterious mutations in BRCA1 or BRCA2 OR a prior risk assessment of ≥ 20% chance of carrying a BRCA1/2 gene mutation - Sedentary, defined as a weekly leisure-time activity score of ≤ 15 on the Godin Leisure-Time Exercise Questionnaire (i.e., engaging in moderate activity < 3 times a week) - Able to perform the level of on-study physical activity, as determined by the Physical Activity Readiness Questionnaire - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 to 75 Sex - Female Menopausal status - Not specified Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - No recent myocardial infarction or stroke Other - Not pregnant - Negative pregnancy test (if premenopausal) - Able to complete study questionnaires OR has a willing friend or family member to assist in questionnaire completion - No ongoing or active infection - No psychiatric illness or social situation that would preclude giving informed consent or study compliance - No other malignancy within the past 2 years except invasive breast cancer or squamous cell or basal cell skin cancer - No other uncontrolled illness - No physical condition that would preclude the amount of daily walking prescribed on study (e.g., severe arthritis or use of a wheelchair, walker, or cane) PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics Endocrine therapy - See Disease Characteristics - Concurrent hormonal therapy (e.g., tamoxifen or aromatase inhibitors) allowed provided patient has completed at least 2 months of therapy before study enrollment Radiotherapy - See Disease Characteristics Surgery - See Disease Characteristics


NCT ID:

NCT00095849


Primary Contact:

Study Chair
Larissa Korde, MD, MPH
National Cancer Institute (NCI)


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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