Web-based Family History Tool

NCT ID: NCT04890327

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-09
• Study Completion Date: 2022-12-31

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.

Conditions

Gynecologic Cancer; Breast Cancer; BRCA1 Mutation; BRCA2 Mutation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Standard of Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Office

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.

Group Type: EXPERIMENTAL

Web-based family health history tool

Intervention Type: OTHER

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

Home

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.

Group Type: EXPERIMENTAL

Web-based family health history tool

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa Frey, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Countries

United States

Other Identifiers

1612017795

Identifier Type: -

Identifier Source: org_study_id