The Genetic Education for Men (GEM) Trial: Web-Based Genetic Education vs. Standard Care in Men From Hereditary Cancer Families

Aim 1: Develop a web-based intervention to increase genetic counseling/testing uptake in men at high risk for carrying a BRCA mutation.

Aim 2: Evaluate the impact of the web-based intervention (WI) vs. usual care (UC)

Aim 3: Examine the behavioral and psychosocial impact of BRCA testing in men from BRCA families.

Identification and Recruitment of Subjects. Participants will be recruited via the Lombardi Comprehensive Cancer Center's Familial Cancer Registry and the Non-therapeutic Subject Registry Shared Resource. These registries contain over 800 female BRCA1/2 positive participants. In addition, the investigators will recontact participants from prior trials who have consented to be recontacted for future research and will accept self-referred index cases who contact the study about participation. Female index cases will be identified based on vital status, recency of contact, and availability of test reports documenting their positive BRCA1/2 status. Where available, pedigrees will also be reviewed.

To protect the privacy of study participants, participants will be recruited through their female BRCA mutation carrier relatives (index patients) who will provide their contact information. The investigators will identify adult female mutation carriers who are enrolled in the Non-therapeutic Subject Registry Shared Resource, Familial Cancer Registry, who received a positive test result as a participant in IRB 2004-133 and provided consent to be contacted about future research studies or who contact the study directly about enrollment. The study staff will mail a study invitation to potentially eligible index cases. This mailing will include: an introductory letter; an informed consent document; a HIPAA Authorization form; study brochures for distribution to male relatives if desired; and a family contact form requesting contact information and current ages for potentially eligible male relatives. The investigators will request that index patients return the Family Contact Form in a self-addressed stamped envelope or complete an electronic version of the form. Consistent with prior research and Institutional Review Board guidance, the letter and Family Contact Form will reiterate that index patients should request permission from their potentially eligible male relative(s) prior to providing contact information to us, and the index patient's signature on the Family Contact Form will attest to this. The packet will also contain information on how women may decline participation (an opt-out post card). If, after 2-3 weeks, individuals do not decline participation, a research assistant will call to determine interest in the study and request completion of the Family Contact Form.