NCT04890327

Web-based Family History Tool

Clinical Utility of a Web-based Tool for Collection of Family Health History and Risk-assessment in Patients Presenting to a Gynecologic Oncology Clinic

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: Female
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

The purpose of this pilot study is to determine if a web-based tool that collects family health history is useful for patients being seen in a gynecologic oncology office setting. This research study is being done because collecting a comprehensive family health history is critical as it allows physicians to appropriately refer patients for genetic counseling and genetic testing. However, prior research indicates that the family health history collected in clinical settings is often inadequate to truly assess the risk of genetic disease. Therefore we plan to explore a web-based program that guides patients through the collection of their family health history and uses this information to create clear concise pedigrees (family tree information) and risk assessment models that can be used by a physician during the office visit.

Detailed description

Patients presenting for a new patient visit with a gynecologic oncologist will be randomized to one of three methods of collection of family health history (Arm 1 - standard of care consisting of interview with the physician; Arm 2 - completion of a web-based family health history tool completed in the clinic waiting room on a computer; Arm 3 - completion of a web-based family health history tool completed prior to the visit and accessed by an email link). A new 4th arm was added with 200 chart reviews to retrospectively look back at how previous family health history was taken for new patients in 2019. The study will evaluate the quality of the family health history collected, the resulting referral to genetic services and patient and physician satisfaction.

Conditions

• Gynecologic Cancer
• Breast Cancer
• BRCA1 Mutation
• BRCA2 Mutation

Interventions

Type	Name	Description
OTHER	Web-based family health history tool	Web-based tool that collects subject's family health history through a series of questions and generates a pedigree which documents a risk assessment report for the physician to use. The risk assessment report uses standard, validated risk scores including GAIL , CLAUS, BRCAPRO which measure breast cancer risk, and MMRPRO which measures endometrial cancer risk, MELAPRO which measures melanoma cancer risk, and PANCPRO which measures pancreatic cancer risk

Timeline

• Start date: 2019-09-09
• Primary completion: 2021-09-15
• Completion: 2022-12-31
• First posted: 2021-05-18
• Last updated: 2023-03-01

Locations

1 site across 1 country: United States