Study of Web-based Decision Aids for Increasing Breast Cancer Chemoprevention in the Primary Care Setting
Condition: Breast Neoplasm
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of this randomized controlled trial (RCT) is to evaluate a decision support
      website (RealRisks) designed to inform patients about breast cancer prevention options. It is
      coupled with a physician-centered (BNAV) decision support website as part of clinical
      workflow in the primary care setting. The investigators hypothesize that improving accuracy
      of breast cancer risk perception and understanding of the risks and benefits of breast cancer
      risk lowering drugs, also known as chemoprevention, will increase the uptake of
      chemoprevention in the primary care setting.
    

Detailed description: 
      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.
    

Intervention name(s): RealRisks; BNAV
Intervention type(s): Other; Other
Intervention description(s): RealRisks is a web-based patient decision aid with modules that present information about risk assessment and chemoprevention.; Breast Cancer Risk Navigation (BNAV) tool is a web-based decision support tool with modules that present pertinent information for primary care providers regarding breast cancer risk assessment and preventative measures for their patients.
Other intervention name(s): RealRisks patient-centered decision aid (DA); Breast Cancer Risk Navigation (BNAV) tool; BNAV provider clinical decision support tool
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Breast Cancer Prevention; Risk Assessment; Chemoprevention; Decision Making