Randomized Controlled Trial of Accessible Online Genetic Services for Cascade Testing for BRCA Mutation Carriers Versus Usual Care in a Clinic Setting

What this Trial Is About

Researchers are evaluating an intervention aimed at increasing genetic testing and education among first degree relatives at risk for inherited gynecologic or breast cancer syndromes, specifically BRCA1 and BRCA2 mutations. This randomized controlled trial compares a multicomponent facilitated approach with standard care to see which method results in a higher proportion of relatives completing genetic testing within 6 months. Identification of these mutations in families is important to tailor cancer treatment and prevention strategies effectively. The trial enrolls 150 probands diagnosed with BRCA1/2 mutations who are randomized to either the intervention or standard care. Those in the standard care group are asked to share a family letter about the mutation with their relatives to encourage testing. In the intervention group, a patient navigator facilitates support including a genetic counseling call, an educational video link, a free saliva kit for genetic testing via an online portal, and follow-up counseling to help connect participants with healthcare providers. A third exploratory arm offers additional support and referrals to advocacy groups for probands who do not qualify for the randomized arms. Participants, mainly first degree relatives, complete quality of life assessments and are monitored for engagement in recommended cancer risk-reducing behaviors over 18 months. Outcomes include the rate of genetic testing completion by 6 months and subsequent preventive actions. The study involves collecting contact information, providing educational materials, genetic testing kits, telephone counseling, and tracking follow-up care. The total duration includes initial testing and longer-term follow-up of health behaviors and quality of life.

FaCT Trial (Facilitated Cascade Testing Trial)