RECRUITING

FaCT Trial (Facilitated Cascade Testing Trial)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Randomized Controlled Trial of Accessible Online Genetic Services for Cascade Testing for BRCA Mutation Carriers Versus Usual Care in a Clinic Setting

Quick Facts

Study Start:2021-07-21
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04613440

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18 years of age or older as documented in the medical record
  2. 2. Speaks and reads English or Spanish as reported by the patient
  3. 3. Patients who are 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.
  4. 4. Patients with a newly diagnosed BRCA mutation presenting for consultation OR patients with known BRCA mutations who have been diagnosed with a confirmed deleterious (pathogenic) variant in BRCA1, or BRCA2 within the preceding 12 months as documented in the medical record
  5. 5. BRCA1/2 mutation that is included on testing panel provided by the clinical genetic testing laboratory
  6. 6. Patients who have at least one at risk relative who meets criteria for first degree relatives
  1. 1. Is unwilling or unable to provide informed consent.
  2. 2. Does not have email access.

Contacts and Locations

Study Contact

Melissa K Frey, MD, MS
CONTACT
212-746-3049
mkf2002@med.cornell.edu
Isabelle R Chandler
CONTACT
212-746-2071
wcmFaCTstudy@med.cornell.edu

Principal Investigator

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

Study Locations (Sites)

Weill Cornell Medicine
New York, New York, 10065
United States
Duke University
Durham, North Carolina, 27710
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Weill Medical College of Cornell University

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-21
Study Completion Date2026-12

Study Record Updates

Study Start Date2021-07-21
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • Genetic Testing, Cascade, BRCA1, BRCA2

Additional Relevant MeSH Terms

  • BRCA1 Mutation
  • BRCA2 Mutation