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Grant Details

Grant Number: 5R21CA185808-02 Interpret this number
Primary Investigator: Schwartz, Marc
Organization: Georgetown University
Project Title: Genetic Testing for Men From Hereditary Cancer Families
Fiscal Year: 2016


Abstract

¿ DESCRIPTION (provided by applicant): Genetic counseling and testing for BRCA1 and BRCA2 mutations is now part of routine clinical care for women with a strong family history of breast and ovarian cancer. Women who carry a BRCA mutation are at extremely high risk for breast and ovarian cancer. Men who are related to BRCA mutation carriers are just as likely to harbor a mutation as their female relatives and are significantly increased risk for breast cancer, pancreatic cancer and particularly prostate cancer. In addition to being at increased risk for developing prostate cancer, men who carry a BRCA1/2 mutation tend to develop a much more aggressive form of prostate cancer than men who do not carry a mutation. Despite this elevated risk, men from BRCA positive families rarely participate in genetic counseling and testing. Low participation in genetic counseling is likely due to men's underestimation of the personal health relevance of testing, lack of physician referral and lower levels of communication with their female relatives who carry the familial mutation. Guidelines recommend genetic counseling referral for men and women from BRCA positive families and low counseling and testing participation limits men's opportunities to use BRCA test results to inform their healthcare decisions. Management guidelines for male BRCA carriers recommend breast and prostate cancer screening beginning at age 35-40 and non-carriers can benefit by avoiding these tests, which are not recommended for most men. To date, little research has focused on BRCA counseling and testing among men. The primary goal of this project is to develop and pilot a brief, low cost intervention to educate men about th personal relevance of BRCA genetic counseling and testing in order to facilitate informed decisions. Our secondary goal is to prospectively evaluate the outcomes of BRCA counseling and testing. We will conduct formative research with men from families in which a BRCA mutation has been identified in order to develop a web-based health education intervention (WI). We will test the WI in a randomized trial against usual care (UC). Using our established registry of over 700 BRCA mutation carriers, we will recruit 375 men (N=318 after attrition) from BRCA positive families who have a 25-50% chance of carrying a mutation and randomize them to WI or UC. All participants will be offered free genetic counseling. We will conduct follow-up surveys at 2-weeks and 6-months following randomization. Primary outcomes are: uptake of genetic counseling and testing and decision satisfaction. Secondary outcomes are prostate and breast cancer screening and distress. This investigation, which is guided by the Ottawa Decision Support Framework and the Informed Choice Model, will have practical clinical significance through the development and evaluation of an intervention for men at the highest level of mutation risk, potentially yielding improved cancer control outcomes for this understudied group.



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