Web-based Family History Tool (Progeny)

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Breast Cancer; BRCA2 Mutation; Gynecologic Cancer; BRCA1 Mutation

Treatments: Other: Web-based family health history tool

Study type: Interventional

Funder types: Other

Identifiers

NCT04890327

1612017795

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Female > 18 years of age. Scheduled for new patient visit with one of the gynecologic oncologists at Weill Cornell Medicine (Melissa Frey MD, Kevin Holcomb MD, Evelyn Cantillo MD, Eloise Chapman MD).

Exclusion criteria

Subjects who cannot communicate in English as the FHH collection tool and surveys are available only in English.

Subjects who were adopted and have no information about their family health history.

Subjects who do not present for the new patient visit.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 3 patient groups

Standard of Care

No Intervention group

Description:

Patient presents to new Gynecologic Oncology appointment, family health history is collected by the physician during the clinic visit. Both the subject and physician complete assessment survey at the completion of clinic visit. Subject's medical record reviewed 6 months following study enrollment to determine subject's diagnosis, whether or not subject underwent genetic counseling and/or genetic testing and review genetic testing results.

Office

Experimental group

Description:

Patient presents to new Gynecologic Oncology appointment, subject is given access to a desk top computer in office and instructed to complete web-based family health history tool. Physician reviews results of patients web-based family health history tool.Subject and physician complete assessment survey at the completion of clinic visit. Subject's medical record reviewed 6 months following study enrollment to determine subject's diagnosis, whether or not subject underwent genetic counseling and/or genetic testing and review genetic testing results.

Treatment:

Other: Web-based family health history tool

Home

Experimental group

Description:

Patient is emailed a link containing web-based family health history tool prior to presenting for new Gynecologic Oncology appointment. Physician reviews results of patients web-based family health history tool. Subject and physician complete assessment survey at the completion of clinic visit. Subject's medical record reviewed 6 months following study enrollment to determine subject's diagnosis, whether or not subject underwent genetic counseling and/or genetic testing and review genetic testing results.

Treatment:

Other: Web-based family health history tool