FaCT Trial (Facilitated Cascade Testing Trial)

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT04613440
Status
Recruiting
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Conditions

  • BRCA1 Mutation
  • BRCA2 Mutation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Family Letter (Standard of Care) — OTHER
    The family letter is given to probands in the standard of care arm and provides information on the familial mutation and serves to encourage first degree relatives to complete genetic testing.
  • Educational Video — OTHER
    The educational video is provided by the clinical genetic testing laboratory and explains the importance and implications of genetic testing. This educational video is shared with first degree relatives in the intervention arm
  • Mailed Saliva Kit for Genetic Testing — OTHER
    The FDR's email will be sent to the genetic testing lab, Invitae, which will allow them to log on to the online portal, create a unique account, and order a genetic testing saliva kit free of charge. The FDR will receive the kit and instructions in the mail. The FDR will collect the saliva sample and send the sample back to the genetic testing laboratory.
  • Telephone Counseling — OTHER
    The FDR's will be contacted and receive post genetic testing phone counseling

Study Details

The purpose of this study is to assess an intervention that incorporates engagement strategies with a medical team navigator, an educational video and accessible genetic testing services to maximize the genetic testing and education of at-risk relatives. In this study, first degree relatives who agree to participate will either receive this intervention or standard of care. The investigators do not know if the facilitated interventional method will be more effective than the standard of care method. This research is being done because identification of patients with inherited gynecologic/breast cancer syndromes is critical to enable delivery of tailored cancer treatment and cancer prevention to both the patients and their at-risk relatives. Cascade genetic testing, defined as extending genetic testing to the family members of affected patients, results in a more precise risk assessment and initiation of appropriate cancer screening and prevention strategies. Therefore, this trial will compare the efficacy of a multicomponent facilitated intervention for first degree relatives vs. standard of care in terms of the overall proportion of first degree relatives who complete genetic testing by 6 months (primary outcome).

Key Dates

Start date
Jul 21, 2021
Status verified
Sep 2025
Primary completion
Mar 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
820 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Other: Standard of care - Proband-mediated cascade testing
    Probands randomized to the standard of care group will be instructed to share a family letter (providing information on the familial mutation) with their FDRs and encourage FDRs to complete genetic testing.
  • Other: Intervention - Facilitated cascade testing
    In the intervention group, a patient navigator will provide facilitated support, including an initial genetic counseling call, an email with a link to an educational video, and, for individuals who are interested in completing testing - a link to create an account for a free saliva kit and a follow-up call to discuss the results and ensure participants are connected with their primary care provider or other clinician, as appropriate.
  • Experimental: Exploratory Arm
    Probands at WCM only who do not meet eligibility criteria for randomization to the intervention and control arms will be offered enrollment in a third arm, in which they will receive the intervention in addition to the option for referral to patient advocacy/support groups including FORCE: Facing Hereditary Cancer EMPOWERED, Sharsheret, SHARE, LatinaSHARE, Oneinforty, Susan G. Komen, Any Mountain, and Genetic Support Foundation, for additional guidance. Probands enrolled in this third arm only will be asked to share the names and contact information for all first, second, and third-degree relatives with whom they have shared their genetic testing results. We estimate enrolling up to 200 subjects into this exploratory third arm (50 probands and 150 Relatives including first, second, and third-degree relatives).

Primary Outcome Measure

Proportion of genetic testing by 6 months among FDRs on each study arm [ Time Frame: 6 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Weill Cornell MedicineNew YorkNew York10065
Melissa K Frey, MD, MS
[email protected]
212-746-3049
Isabelle R Chandler
[email protected]
212-746-2071
Melissa K Frey, MD (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27710
Haley Moss, MD MBA
Haley Moss, MD MBA (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Jose Alejandro Rauh-Hain
[email protected]
Jose Alejandro Rauh-Hain, MD (PRINCIPAL_INVESTIGATOR)
Karen Lu, MD (PRINCIPAL_INVESTIGATOR)
Roni Nitecki, MD (PRINCIPAL_INVESTIGATOR)

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