A Pilot Study of a Three Month Intervention for Increasing Physical Activity in Sedentary Women at Risk for Breast Cancer
Evidence suggests that high levels of physical activity can decrease breast cancer risk.
Physical activity could therefore represent a viable breast cancer prevention strategy.
In order to study the effect of physical activity on breast cancer risk, we must first
develop feasible and efficacious physical activity interventions.
To determine the rate of compliance with a physical activity intervention using a pedometer,
a physician prescription, and a motivational booklet.
To determine whether this intervention is more effective than a control of stretching
exercises at increasing physical activity.
To determine whether physical activity as measured by a pedometer correlates with other
measures of physical activity.
To assess the effect of the physical activity intervention on serum biomarkers, quality of
life, functional capacity and body composition.
To examine long-term compliance with a program of increased physical activity and assess
post program exercise motivation and adherence.
Eligible patients are women age 18-75 who meet one of the following criteria:
History of breast cancer without evidence of recurrent disease.
Gail model 5 year risk greater than 1.7%.
Claus model lifetime risk greater than 20%.
History of appropriately treated DCIS.
History of high risk lesion on breast biopsy (ADH, ALH, LCIS).
Known or suspected BRCA1 or BRCA2 mutation.
Patients must be sedentary at baseline and must be medically fit to exercise.
This is a randomized pilot study designed to assess the feasibility of a physical activity
intervention in breast cancer survivors and women at high risk for breast cancer.
Stage I: Patients undergo a baseline activity evaluation for one week which involves wearing
a sealed pedometer - those that have an average daily step count of less than 5,000 steps
are eligible for randomization.
Stage II: Patients are assigned to either a walking intervention, (including a pedometer, a
physician exercise prescription with a final goal of walking 10,000 steps per day, and a
motivational booklet) or a control of stretching exercise for a period of 12 weeks.
Biomarkers, functional capacity, body composition and diet are assessed at the beginning and
end of study.
This study plans to randomize 80 subjects, and has a greater than 90% power to detect a mean
increase of 3,000 steps per day in intervention subjects.
Primary Purpose: Treatment
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|