CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,073 enrolled
Drug / intervention
Patient Directed Standard of Careother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03985852
NCT03985852N/ACompleted

Broadening the Reach, Impact, and Delivery of Genetic Services

University of Utah·interventional·Posted Jun 14, 2019·Updated Sep 22, 2025

In Brief

A clinical study evaluating Patient Directed Standard of Care for Cancer and Risk Reduction Behavior. Completed, enrolled 3,073 participants across 2 sites.

Detailed Summary

The purpose of this study is to compare the uptake of genetic testing among patients randomized with two different models of genetic services delivery (a patient-directed model and an enhanced standard of care model) and examine whether the impact on uptake differs by race/ethnicity and rurality. This study will also compare the effect of these delivery models on adherence to cancer prevention and screening recommendations and other patient responses.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsNew York University

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJun 14, 2019
Enrollment StartFeb 19, 2020
Primary CompletionAug 31, 2023
Study CompletionAug 31, 2024
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 7.0 years ago

Interventions

Patient Directed Standard of Careother

The pre-test genetic counseling visit will be conducted through access to an automated genetics education assistant accessed through the patient portal. The automated approach will address all the components of the pre-test counseling and contains content designed by the genetic counselors at the University of Utah and NYU. Patients will have the option to contact genetic counselors through the patient portal, by phone, or in person but this will not be required. All results will be reviewed by a genetic counselor. Negative results will be returned by the automated genetics education assistant. Genetic counselors will return results for pathogenic variants and variants of uncertain significance via phone.