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Clinical trial
Facilitated cascade testing (FaCT): a randomized controlled trial
  1. Roni Nitecki1,
  2. Haley A Moss2,
  3. Catherine H Watson2,
  4. Diana L Urbauer3,
  5. Alexander Melamed4,
  6. Karen H Lu1,
  7. Steven M Lipkin5,
  8. Kenneth Offit6,
  9. Jose Alejandro Rauh-Hain1 and
  10. Melissa K Frey7
  1. 1Department of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston, Texas, USA
  2. 2Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, North Carolina, USA
  3. 3Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
  4. 4Department of Obstetrics and Gynecology and Herbert Irving Comprehensive Cancer Center, Columbia University, New York Presbyterian Hospital, New York, New York, USA
  5. 5Departments of Medicine and Genetic Medicine, Weill Cornell Medicine, New York, New York, USA
  6. 6Clinical Genetics Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York, USA
  7. 7Division of Gynecologic Oncology, Weill Cornell Medicine, New York, New York, USA
  1. Correspondence to Dr Melissa K Frey; mkf2002{at}med.cornell.edu

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

  • ovarian cancer
  • BRCA1 protein
  • BRCA2 protein

https://doi.org/10.1136/ijgc-2020-002118

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    Footnotes

    • Twitter @MelissaFrey2

    • Collaborators Brandelyn N Pitcher.

    • Contributors All authors have reviewed the manuscript.

    • Funding This work was supported by grants from the National Institutes of Health National Cancer Institute (JAR-H: K08 CA234333; RN, KHL, DLU, and JAR-H: P30 48CA016672; KHL: 5T32 CA101642), and National Center for Advancing Translational Sciences (AM: KL2TR001874; MKF:KL2TR002385). The funding sources were not involved in the development of the research hypothesis, study design, data analysis, or manuscript writing.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement No data are available.