MedTrace Logo

FaCT Trial (Facilitated Cascade Testing Trial)

NCT04613440 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 820

Last updated 2025-10-01

No results posted yet for this study

Summary

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).

Conditions

  • BRCA1 Mutation
  • BRCA2 Mutation

Interventions

OTHER

Family Letter (Standard of Care)

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.

OTHER

Educational Video

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

OTHER

Mailed Saliva Kit for Genetic Testing

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.

OTHER

Telephone Counseling

The FDR's will be contacted and receive post genetic testing phone counseling

Sponsors & Collaborators

  • Basser Research Center for BRCA

    collaborator UNKNOWN

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Melissa K Frey, MD, MS · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-21
Primary Completion
2026-03-31
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04613440 on ClinicalTrials.gov