BC-DAISY: A Breast Cancer Decision Aid System
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to develop a web-based decision aid to help women at high risk
      for breast cancer make informed breast cancer prevention choices. These choices include
      chemoprevention, surgery, genetic counseling, or regular screening in accordance with
      recommended guidelines.
    

Detailed description: 
      Decisions about breast cancer are complex and preference-based. Existing decision aids that
      help identify women eligible for tamoxifen based on their breast cancer risk, such as the
      Breast Cancer Risk Assessment Tool (BCRAT), were not designed to identify women's risks for
      side-effects, her preferences for outcomes affected by treatment, nor the net balance of
      benefits and risks. It is possible to predict the risks of side effects of treatments
      according to patient characteristics, using patient-specific models.Our goal is to develop a
      decision aid, TXplore, that rates the overall benefit:risk profiles of various breast cancer
      prevention strategies according to a woman's risks for breast cancer, side-effects, and
      preferences. Each user will receive a customized report card grading each available
      prevention option, using preference-weighted risk:benefit grades; users can also explore
      personalized feedback from the program. Our hypotheses are that this tool can improve the
      implementation of appropriate prevention strategies, promote risk reduction behavior, and
      improve PCP's ability to identify and counsel high risk women.We propose building on modeling
      techniques that link the benefits and risks of preventive strategies to patient
      characteristics and preferences. We now seek to conduct focus groups and usability tests on
      end-users to optimize the design of the prototype TXplore.

      The Specific Aims are:

        1. To optimize the design of TXplore by focus groups conducted among diverse high-risk
           women and PCPs to a) identify the domains driving decisions about prevention and explore
           the framing of questions comparing the relative importance of one domain to another,
           synthesizing this information as preference trade-off questions; and b) explore the
           framing of risk:benefit grades and personalized feedback.

        2. To assess the comprehensibility of preference trade-off questions by testing each
           question on a diverse sample of 50 high-risk women, revising and retesting.

        3. To assess the usability of TXplore for patients and PCPsThe successful completion of
           this project will produce a novel tool for counseling women about their individual
           benefits and risks of breast cancer prevention strategies. It will be the first tool of
           its kind to integrate individual patient risks and preferences into decision support.
    

Intervention name(s): TX-plore
Intervention type(s): Device
Intervention description(s): PI has terminated at institution and there is no one available to report.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: decision aids; high risk; breast cancer; breast cancer prevention