Clinical trial NCT04890327: Web-based Family History Tool
Official title: Clinical Utility of a Web-based Tool for Collection of Family Health History and Risk-assessment in Patients Presenting to a Gynecologic Oncology Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Cancer
Breast Cancer
BRCA1 Mutation
BRCA2 Mutation
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of subjects with high quality family health history (FHH)
timeFrame: Anytime between 18 - 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Melissa Frey, MD
role: PRINCIPAL_INVESTIGATOR
References: