Facilitated cascade testing (FaCT): a randomized controlled trial. Issue 5 (18th December 2020)

• Record Type: Journal Article
• Authors: Nitecki, Roni; Moss, Haley A; Watson, Catherine H; Urbauer, Diana L; Melamed, Alexander; Lu, Karen H; Lipkin, Steven M; Offit, Kenneth; Rauh-Hain, Jose Alejandro; Frey, Melissa K
• Is Part Of: International journal of gynecological cancer. Volume 31:Issue 5(2021)
• Page Start: 779
• Page End: 783
• Publication Date: 2020-12-18
• Subjects: ovarian cancer -- BRCA1 protein -- BRCA2 protein; Generative organs, Female -- Cancer -- Periodicals; 616.99465
• DOI: 10.1136/ijgc-2020-002118
• Languages: English
• ISSNs: 1048-891X

Abstract

Abstract : Background: Identifying mutation-carrying relatives of patients with hereditary cancer syndromes via cascade testing is an underused first step in primary cancer prevention. A feasibility study of facilitated genetic testing of at-risk relatives of patients with a known pathogenic mutation demonstrated encouraging uptake of cascade testing. Primary objective: Our primary objective is to compare the proportion of genetic testing of identified first-degree relatives of probands with a confirmed BRCA1/2 mutation randomized to a facilitated cascade testing strategy versus standard of care, proband-mediated, information sharing. Study hypothesis: We hypothesize that facilitated cascade testing will drive significantly higher uptake of genetic testing than the standard of care. Trial design: The FaCT (Facilitated Cascade Testing) trial is a prospective multi-institutional randomized study comparing the efficacy of a multicomponent facilitated cascade testing intervention with the standard of care. Patients with a known BRCA1/2 mutation (probands) cared for at participating sites will be randomized. Probands randomized to the standard of care group will be instructed to share a family letter with their first-degree relatives and encourage them to complete genetic testing. First-degree relatives of probands randomized to the intervention arm will receive engagement strategies with a patient navigator, an educational video, and accessible genetic testing services. Major inclusion/exclusion criteria: Adult participants who are first-degree relatives of a patient with a BRCA1/2 mutation and have not had prior genetic testing will be included. Primary endpoint: Analyses will assess the proportion of first-degree relatives identified by the proband who complete genetic testing by 6 months in the intervention arm versus the control arm. Sample size: One hundred and fifty probands with a BRCA1/2 mutation will be randomized. Each proband is expected to provide an average of 3 relatives, for an expected 450 participants. Estimated dates for completing accrual and presenting results: January 2024. Trial registration: NCT04613440