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 study.

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.