BC-DAISY: A Breast Cancer Decision Aid System

June 4, 2012 updated by: Rhode Island Hospital

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.

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / Treatment

Device: TX-plore

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:

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.
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.
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.

Study Type

Interventional

Enrollment (Actual)

195

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Rhode Island
  - Providence, Rhode Island, United States, 02903
    - Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Usability feedback on new decision aid for women at high risk for breast cancer from patients and physicians. Time Frame: 9/01/06-8/31/07	9/01/06-8/31/07

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Investigators

Principal Investigator: Nananda Col, MD, MPP, MPH, Rhode Island Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

June 29, 2006

First Submitted That Met QC Criteria