NCT04245176

Genetic Testing for All Breast Cancer Patients (GET FACTS)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to determine the impact of a novel genetic counseling method on surgical decisions in individuals with newly diagnosed breast cancer This research study involves an expedited and surgery-specific form of genetic counseling. The names of the study methods involved in this trial are/is: * Quantitative genetic counseling (discussion is guided by tables and graphs) * Standard genetic counseling

Detailed description

* The research study procedures include screening for eligibility and study interventions including evaluations and follow up visits * After receiving genetic testing, participants will be placed into one of two counseling methodology groups: * Standard genetic counseling: Standard of care discussion * Quantitative genetic counseling: Discussion is guided by tables and graphs. * Participants will be on the research study for up to six months, with an optional extension to two years. * It is expected that about 450 people will participate. * This research study is a Feasibility Study, which is the first-time investigators are examining this form of genetic counseling. * This is a randomized study. Randomization means being put into a group by chance. It is like flipping a coin. Neither the participant nor the Investigator will choose the group the participant is assigned to.

Conditions

• Breast Cancer
• Invasive Breast Cancer
• In Situ Breast Cancer
• Genetic Testing

Interventions

Type	Name	Description
BEHAVIORAL	Standard Genetic Counseling	Standard genetic counseling: Standard of care discussion
BEHAVIORAL	Quantitative Genetic Counseling	Quantitative genetic counseling: Discussion is guided by tables and graphs.

Timeline

• Start date: 2020-01-31
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2020-01-28
• Last updated: 2025-03-05

Locations

1 site across 1 country: United States