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BC-DAISY: A Breast Cancer Decision Aid System

21 Years
75 Years
Not Enrolling
Breast Cancer

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Trial Information

BC-DAISY: A Breast Cancer Decision Aid System

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

Inclusion Criteria:

- between the ages of 21 - 75

- at least one first degree relative with breast cancer or a Gail Model score
signifying high risk

- female

- having had contact with a PCP (physician or nurse practitioner)within the last year

- being a patient at a participating clinic (for usability and pilot study)

Exclusion Criteria:

- Inability to give informed, voluntary consent

- History of breast cancer or LCIS

- Language, vision, or reading difficulties, or non-English speaking

- Pregnancy

- women over 75 because of the lack of data guiding the impact of preventive treatments
among this age group.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Usability feedback on new decision aid for women at high risk for breast cancer from patients and physicians.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Nananda Col, MD, MPP, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rhode Island Hospital


United States: Institutional Review Board

Study ID:




Start Date:

July 2006

Completion Date:

December 2009

Related Keywords:

  • Breast Cancer
  • decision aids
  • high risk
  • breast cancer
  • breast cancer prevention
  • Breast Neoplasms



Rhode Island HospitalProvidence, Rhode Island  02903