Project Overview +

The purpose of this project is to develop and test a web-delivered, tailored decision aid for women at risk for breast and ovarian cancer. Existing educational materials are refined then offered in an interactive website featuring greater personalization of risk information, using validated risk communication techniques in a patient-friendly Web-based application.

Such technologies are needed to expand the reach and improve the cost- effectiveness of breast cancer genetic services and are part of a growing movement within clinical care to provide validated patient decision aids.

Aims +

Aim 1. Use feedback from both patients and a multidisciplinary panel of experts in the field to refine our existing educational website for women considering BRCA 1/2 genetic testing.

Aim 2. Use a small RCT to pilot test our educational website with a sample of women recruited from the University of Michigan (U-M) Breast and Ovarian Cancer Risk Evaluation Program.

Aim 3. Use results from Aims 1-2 to prepare an R01 application to conduct a larger, multi-site RCT of the study website (vs. usual care) for increasing patients' knowledge and decisional satisfaction, reducing patient cancer-related worry, and reducing provider burden.

Participants +

Forty women scheduled for a visit with the University of Michigan Breast and Ovarian Cancer Risk Evaluation Program

Intervention +

The pre-existing educational materials are modified to include:

  1. Updated cancer risk information based on the most recent epidemiological data,
  2. A new section on protections offered by the Genetic Information Nondiscrimination Act, and
  3. Plain language and a glossary of terms to make the content more approachable for patients with diverse literacy levels.

The site also incorporates a personalized risk assessment module that offers recommendations for further assessment, if warranted, based on the patient's survey data. The survey assesses Gail scores and risk factors for a BRCA mutation.

As part of the existing clinic protocol, all women contacting the BOCRP for an appointment are mailed a pre-clinic questionnaire, which contains items assessing demographics, family history, and baseline psychosocial measures of interest. This initial questionnaire is completed at home and returned by mail to the clinic coordinator. An appointment is scheduled once the initial questionnaire is received. Recruitment for the current study will take place by telephone when patients contact the clinic for an appointment.

If a woman agrees to participate, she will be asked to arrive at clinic prior to her scheduled appointment where she will be greeted by the study RA and asked to complete a brief baseline assessment (including measures of knowledge, risk perceptions, and worry) and informed consent.

Participants randomized to the intervention arm of the study will then be asked to review the website's educational modules and complete the personalized risk assessment. These participants will be also be given the site URL to reference materials at home following their clinic visit.

Findings +

The website was rated highly by its users across multiple domains (e.g., easy to understand, providing useful information), with an overall mean score of 3.54 on a 4-point scale (1 = poor to 4 = excellent). In addition, use of the site was associated with briefer genetic counseling sessions (mean = 43 minutes) than a control arm where participants did not view the website (mean = 58 minutes).

Conclusion +

Web-based education materials show promise as an ancillary tool in genetic counseling to reduce the face-to-face clinician time needed for basic genetic education and free up time to discuss issues more specific to the individual patient's care.

The website is being used by MPHI as part of its public education about breast cancer genetics - https://www.migeneticsconnection.org/brca/

Breast Cancer Genetics Usability Test

03/01/2009 - 02/28/2010

Sponsor(s)

University of Michigan Comprehensive Cancer Center

Principal Investigator:

J. Scott Roberts, PhD

Co-Investigator(s):

Sofia D. Merajver, MD, PhD
Kara J. Milliron, MS, CGC