Study of Web-based Decision Aids for Increasing Breast Cancer Chemoprevention in the Primary Care Setting

Breast cancer is the most common malignancy among women in the U.S. and the primary
prevention of this disease is a major public health issue. The U.S. Preventive Services Task
Force and other professional organizations recommend that clinicians discuss chemoprevention
with high-risk women. Breast cancer chemoprevention with anti-estrogens, such as tamoxifen,
raloxifene, exemestane, and anastrozole, is under-utilized, despite several randomized
controlled trials demonstrating a 40-65% decrease in breast cancer incidence among high-risk
women. Compounding this underutilization is the fact that a large proportion of women may be
unaware of their high-risk status due to the investigators' inability to adequately screen
them in the primary care setting. Further research is needed to determine how knowledge
about breast cancer, actual/perceived risk, and risks/benefits of chemoprevention are best
communicated to women in order to promote breast cancer prevention strategies.

The investigators hypothesize that combining a patient-centered decision aid with a
physician-centered decision support tool integrated into clinic workflow will improve
accuracy of breast cancer risk perception, facilitate referrals for specialized risk
counseling, and increase chemoprevention uptake. We anticipate that the BNAV tool will
facilitate referrals to the breast clinic by primary care providers (PCPs) and that the
RealRisks decision aid will prime high-risk women to seek these referrals. The primary
endpoint is uptake of a selective estrogen receptor modulator (SERM) or Aromatase inhibitor
(AI) for breast cancer chemoprevention at 6 months (after the next primary care appointment)
in the active arm compared to usual care.

Inclusion Criteria:

- 5-year breast cancer risk ≥ to 1.67% or lifetime risk ≥ to 20% according to the Gail
risk model; or a 5-year breast cancer risk ≥ 1.67% according to the Breast Cancer
Surveillance Consortium (BCSC) model

- The participant understands and is willing to provide informed consent in English or
Spanish

- Has a primary care provider at Columbia University Medical Center (CUMC) / New
York-Presbyterian Hospital

Exclusion Criteria:

- Prior use of a selective estrogen receptor modulator (SERM) or aromatase inhibitor
(AI) for chemoprevention

- Prior history of breast cancer