Physical Activity Intervention in Sedentary Women at Risk of Breast Cancer
This pilot study, which is being conducted at the NIH
Clinical Center, assesses the feasibility of a simple lifestyle intervention for
increasing physical activity among breast cancer survivors and women at high risk of
breast cancer who are between 18 and 75 years of age and sedentary. Participants are
randomized to either a 12 week walking program or a stretching program.
The primary objective of the study is to evaluate whether the intervention is
successful in increasing levels of physical activity. Secondary objectives include
exploring the effects of physical activity on breast cancer biomarkers, such as
mammographic density, serum biomarkers, and ductal lavage fluid. The study also assesses
body composition and functional capacity, as well as patient-reported outcomes (PRO),
including quality of life. Outcomes Research staff designed the PRO component of the
This feasibility study serves as the first step in designing larger, randomized trials
of physical activity interventions in high-risk populations and may have implications for
trials in other at-risk and underserved groups.