Web-based Family History Tool

NCT04890327 | Completed

• 1 other identifier: 1612017795
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer; Breast Cancer; BRCA1 Mutation; BRCA2 Mutation

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with high quality family health history (FHH)

  To compare the amount of subjects with a high quality family health history in each of the study arms that properly assesses disease risk. Currently FHH in a gynecologic oncology clinic setting is inadequate to assess disease risk. The use of a web-based FHH collection tool that also offers the providers with a risk assessment tool may address these challenges and increase the comprehensiveness of FHH collection and risk assessment in the gynecologic oncology clinic. For a pedigree to be considered high quality, at least one individual in the pedigree must meet all quality criteria ("high quality relative"). 1. Three generations of relatives 2. Relatives' lineage (e.g. paternal or maternal side) 3. Relatives' gender 4. An up-to-date FHH 5. Pertinent negatives in FHH noted (i.e. no FHH of cancer) 6. Age of disease onset in affected relatives 7. For deceased relatives - the age of death 8. For deceased relatives - the cause of death.

  Anytime between 18 - 24 months

Study Arms (3)

Standard of Care

NO INTERVENTION

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

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.

Other: Web-based family health history tool

Home

EXPERIMENTAL

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.

Other: Web-based family health history tool

Interventions

Web-based family health history tool 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; Office

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Melissa Frey, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: May 18, 2021
• Study Start: September 9, 2019
• Primary Completion: September 15, 2021
• Study Completion: December 31, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)