Family History and Cancer Risk Study

NCT05079334 | Active Not Recruiting Results

• 2 other identifiers: 201202U01CA232829
• Study Type: observational
• Target: 1,847
• Locations: 1 country
• Sites: 2

Brief Summary

Investigators from Vanderbilt University Medical Center (VUMC), Duke University, and Meharry Medical College (MMC) are collaborating on a family health history study to deploy a family health history (FHH) platform, MeTree. Recruited participants will complete surveys, the MeTree questionnaire, and MeTree will determine the participant's cancer risk based on current guidelines. The study team will offer genetic counseling to high-risk participants. Investigators will track participant outcomes and behaviors from the use of MeTree to determine the efficiency of the use of MeTree compared to completion of pedigrees in clinic.

Conditions

Neoplastic Syndromes, Hereditary; Comparative Effectiveness Research

Outcome Measures

Primary Outcomes (1)

• MeTree Completion (REACH)

  Proportion of participants sent a MeTree link who complete the MeTree family health history questionnaire, defined by generation of a MeTree risk report. Engagement steps (link clicked, account created) will be summarized descriptively. 95% confidence intervals will be reported using the Wilson method; subgroup comparisons by site and demographics will be exploratory.

  From enrollment to study completion (up to 3 years)

Secondary Outcomes (2)

• EHR-based Identification for High Risk of Hereditary Cancer (Effectiveness)

  Assessed at two time points: baseline (pre-MeTree, using all available prior EHR history) and 12 months after MeTree completion.

• Genetic Counseling Appointment Lengths

  At the genetic counseling appointment (index visit) occurring after MeTree results review and within 12 months after enrollment.

Interventions

MeTree Questionnaire

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Anyone over 18 years old, receiving care at our study site (virtual included), and willing/able to use the internet.

You may qualify if:

• Receiving care at sites included in study
• Able to read and communicate in English
• Willing to use the Internet
• Currently enrolled in the patient portal, or willing to enroll (VUMC-specific)

You may not qualify if:

• Non-study site patient
• Diagnosed with a terminal illness
• Unable to speak/read English
• Unable/unwilling to use the Internet
• Previous genetic testing and/or counseling from the VUMC Hereditary Cancer Clinic

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Meharry Medical College

Nashville, Tennessee, 37208, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (1)

• Mittendorf KF, Bland HT, Andujar J, Celaya-Cobbs N, Edwards C, Gerhart M, Hooker G, Hubert M, Jones SH, Marshall DR, Myers RA, Pratap S, Rosenbloom ST, Sadeghpour A, Wu RR, Orlando LA, Wiesner GL. Family history and cancer risk study (FOREST): A clinical trial assessing electronic patient-directed family history input for identifying patients at risk of hereditary cancer. Contemp Clin Trials. 2025 Jan;148:107714. doi: 10.1016/j.cct.2024.107714. Epub 2024 Oct 10.

  PMID: 39395532 BACKGROUND

MeSH Terms

Conditions

Neoplastic Syndromes, Hereditary

Condition Hierarchy (Ancestors)

Neoplasms; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Dr. Georgia Wiesner
• Organization: Vanderbilt University Medical Center

georgia.wiesner@vumc.org

615-936-2660

Study Officials

• Georgia Wiesner, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 15, 2021
• Study Start: January 1, 2022
• Primary Completion: August 31, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 10, 2026
• Results First Posted: February 10, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)