Genetic testing for BRCA1 and BRCA2 (BRCA1/2) mutations has become part of routine clinical care for women with a strong family history of breast or ovarian cancer. Women who carry a BRCA1/2 mutation have elevated lifetime risks of developing breast and ovarian cancer. Management guidelines consist of intensive surveillance or consideration of risk reducing mastectomy and oophorectomy. Although these surgical approaches significantly reduce the risk of associated cancers, many carriers are reluctant to choose these strategies. Given the complex and emotional nature of these highly consequential decisions, it is not surprising that many carriers report dissatisfaction with the information and counseling they have received regarding these decisions. Moreover, they often rate management decision making as one of the most stressful aspects of BRCA1/2 testing. The goal of this study is to evaluate the effectiveness of potentially disseminable interventions to help patients make well- informed, and implemented, management decisions that are consistent with their preferences. In order to accomplish this, the effects of traditional print information, web- based information, and a decision aid (DA) also delivered in print and interactively via the web will be assessed. DAs have been shown to be effective in helping patients make complex medical decisions. Although several DAs have been developed for BRCA1/2 carriers, few have been tested in randomized trials. Thus, in this large multi-site trial, a 2 X 2 randomized factorial design will be employed to evaluate both the effectiveness and cost effectiveness of the intervention (information only vs. information + DA) and delivery mode (web vs. print) within a clinical population of women receiving positive BRCA1/2 results. Multiple patient outcomes, including utilization of risk reducing surgery, health related quality of life, and distress will be assessed. In addition, the mechanisms by which the interventions impact on patient outcomes as well as characteristics and predictors of individuals most and least likely to benefit from the interventions and to utilize the web and print materials will be identified. The findings from this innovative research will be relevant not only to the increasing numbers of identified BRCA1/2 carriers, but also to other populations as """"""""personalized medicine"""""""" becomes more widespread. Important questions about how to best target DAs and the potential advantages of web-based interventions will also be evaluated.

Public Health Relevance

The purpose of this study is to assess the clinical effectiveness of print and web based interventions that provide information and decision support to women who have BRCA1/2 mutations. By facilitating informed decision making, it is hoped that these high risk women will implement breast and ovarian cancer risk management decisions that have positive effects on their well being and quality of life, and which ultimately reduce morbidity and mortality from these cancers.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA135179-03
Application #
8074020
Study Section
Psychosocial Risk and Disease Prevention Study Section (PRDP)
Program Officer
Shaikh, Abdul R
Project Start
2009-07-01
Project End
2014-05-31
Budget Start
2011-06-01
Budget End
2012-05-31
Support Year
3
Fiscal Year
2011
Total Cost
$382,346
Indirect Cost
Name
Georgetown University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
049515844
City
Washington
State
DC
Country
United States
Zip Code
20057