Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT04613440

FaCT Trial (Facilitated Cascade Testing Trial)

Led by Weill Medical College of Cornell University · Updated on 2025-10-01

820

Participants Needed

3

Research Sites

279 weeks

Total Duration

On this page

Sponsors

W

Weill Medical College of Cornell University

Lead Sponsor

B

Basser Research Center for BRCA

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

FaCT Trial (Facilitated Cascade Testing Trial)

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older as documented in the medical record
  • Speaks and reads English or Spanish as reported by the patient
  • Currently receiving diagnostic, treatment, or follow-up care at New York Presbyterian/Weill Cornell Medical Center, MD Anderson Cancer Center, Duke University, or Columbia University
  • Newly diagnosed with BRCA mutation or diagnosed with a confirmed deleterious BRCA1 or BRCA2 variant within the last 12 months
  • BRCA1/2 mutation included on testing panel provided by the clinical genetic testing laboratory
  • Has at least one at-risk first degree relative
Not Eligible

You will not qualify if you...

  • Unwilling or unable to provide informed consent
  • Does not have email access

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Weill Cornell Medicine

New York, New York, United States, 10065

Actively Recruiting

2

Duke University

Durham, North Carolina, United States, 27710

Actively Recruiting

3

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

M

Melissa K Frey, MD, MS

CONTACT

I

Isabelle R Chandler

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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