Trial Outcomes & Findings for Family History and Cancer Risk Study (NCT NCT05079334)

Last Updated: 2026-02-10

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Target enrollment

1847 participants

Primary outcome timeframe

From enrollment to study completion (up to 3 years)

Results posted on

2026-02-10

Participant Flow

Participant milestones

Participant milestones
Measure	All Enrolled Participants Participants enrolled in the FOREST observational cohort who were invited to complete study procedures, including a baseline survey and a web-based family health history questionnaire (MeTree). Completion of study components was voluntary, and participants were not assigned to interventions or comparison groups.
Overall Study STARTED	1847
Overall Study COMPLETED	620
Overall Study NOT COMPLETED	1227

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Family History and Cancer Risk Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=1847 Participants Evaluates the proportion of participants who initiate and complete each step of the FOREST study, including baseline survey and MeTree family health history tool. Data are tracked through REDCap and MeTree backend to measure engagement and completion. MeTree Family Health History Tool: A web-based family health history collection and risk assessment platform integrated with EHR systems. Participants complete the MeTree survey, which generates personalized risk reports for hereditary cancer syndromes and provides guideline-based recommendations, including genetic counseling referrals when indicated.
Age, Continuous	54.8 years STANDARD_DEVIATION 15.0 • n=41 Participants
Sex: Female, Male Female	1330 Participants n=41 Participants
Sex: Female, Male Male	517 Participants n=41 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	38 Participants n=41 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1550 Participants n=41 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	259 Participants n=41 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=41 Participants
Race (NIH/OMB) Asian	19 Participants n=41 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	6 Participants n=41 Participants
Race (NIH/OMB) Black or African American	184 Participants n=41 Participants
Race (NIH/OMB) White	1435 Participants n=41 Participants
Race (NIH/OMB) More than one race	0 Participants n=41 Participants
Race (NIH/OMB) Unknown or Not Reported	197 Participants n=41 Participants

PRIMARY outcome

Timeframe: From enrollment to study completion (up to 3 years)

Outcome measures

Outcome measures
Measure	Reach n=1847 Participants Evaluates the proportion of participants who initiate and complete each step of the FOREST study, including baseline survey and MeTree family health history tool. Data are tracked through REDCap and MeTree backend to measure engagement and completion. MeTree Family Health History Tool: A web-based family health history collection and risk assessment platform integrated with EHR systems. Participants complete the MeTree survey, which generates personalized risk reports for hereditary cancer syndromes and provides guideline-based recommendations, including genetic counseling referrals when indicated.	Standard of Care Analysis population comprises of 31 MeTree participants who completed MeTree and genetic counseling and 31-non MeTree participants who had genetic counseling appointments at the same clinical over the same time frame as the MeTree study participants
MeTree Completion (REACH)	1847 Participants	—

SECONDARY outcome

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

Population: Subset of participants enrolled at VUMC who completed MeTree

Billing code based identification of personal or family history indicators of hereditary cancer

Outcome measures

Outcome measures
Measure	Reach n=266 Participants Evaluates the proportion of participants who initiate and complete each step of the FOREST study, including baseline survey and MeTree family health history tool. Data are tracked through REDCap and MeTree backend to measure engagement and completion. MeTree Family Health History Tool: A web-based family health history collection and risk assessment platform integrated with EHR systems. Participants complete the MeTree survey, which generates personalized risk reports for hereditary cancer syndromes and provides guideline-based recommendations, including genetic counseling referrals when indicated.	Standard of Care Analysis population comprises of 31 MeTree participants who completed MeTree and genetic counseling and 31-non MeTree participants who had genetic counseling appointments at the same clinical over the same time frame as the MeTree study participants
EHR-based Identification for High Risk of Hereditary Cancer (Effectiveness) Pre-MeTree	155 Participants	—
EHR-based Identification for High Risk of Hereditary Cancer (Effectiveness) Post-MeTree	111 Participants	—

SECONDARY outcome

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

Population: Analysis population comprises of 31 MeTree participants who completed MeTree and genetic counseling and 31-non MeTree participants who had genetic counseling appointments at the same clinical over the same time frame as the MeTree study participants

Length of genetic counseling appointments in minutes

Outcome measures

Outcome measures
Measure	Reach n=31 Participants Evaluates the proportion of participants who initiate and complete each step of the FOREST study, including baseline survey and MeTree family health history tool. Data are tracked through REDCap and MeTree backend to measure engagement and completion. MeTree Family Health History Tool: A web-based family health history collection and risk assessment platform integrated with EHR systems. Participants complete the MeTree survey, which generates personalized risk reports for hereditary cancer syndromes and provides guideline-based recommendations, including genetic counseling referrals when indicated.	Standard of Care n=31 Participants Analysis population comprises of 31 MeTree participants who completed MeTree and genetic counseling and 31-non MeTree participants who had genetic counseling appointments at the same clinical over the same time frame as the MeTree study participants
Genetic Counseling Appointment Lengths	45 Minutes Standard Deviation 15.1	48 Minutes Standard Deviation 15

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Georgia Wiesner

Vanderbilt University Medical Center

Phone: 615-936-2660

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place