FaCT Trial (Facilitated Cascade Testing Trial) (NCT04613440)
Randomized Controlled Trial of Accessible Online Genetic Services for Cascade Testing for BRCA Mutation Carriers Versus Usual Care in a Clinic Setting
๐ฉบ Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Weill Cornell Medicine โ New York, New York
Age range: 18 Years
๐งช Interventions in This Study
- Family Letter (Standard of Care) (OTHER)
- Educational Video (OTHER)
- Mailed Saliva Kit for Genetic Testing (OTHER)
- Telephone Counseling (OTHER)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (3 Sites)
- Weill Cornell Medicine โ New York, New York
- Duke University โ Durham, North Carolina
- MD Anderson Cancer Center โ Houston, Texas
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in BRCA1 Mutation
- BRCA Founder OutReach (BFOR) Study โ Los Angeles, California
- BRCA1/2 Flu Vaccine โ Philadelphia, Pennsylvania
- Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation โ Los Angeles, California
- Olaparib and ASTX727 in BRCA1/2- and Homologous Recombination Deficient (HRD)-Mutated Tumors โ San Francisco, California
- An Intervention to Increase Genetic Testing in Families Who May Share a Gene Mutation Related to Cancer Risk and An Intervention to Help Patients and Their Primary Care Providers Stay Up-to-date About Uncertain Genetic Test Results โ Basking Ridge, New Jersey
Explore by condition: All BRCA1 Mutation clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.