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Broadening the Reach, Impact, and Delivery of Genetic Services

NCT03985852 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3073

Last updated 2025-09-22

Study results available
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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.

Conditions

  • Cancer
  • Risk Reduction Behavior

Interventions

OTHER

Patient Directed Standard of Care

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.

Sponsors & Collaborators

Principal Investigators

  • Kimberly Kaphingst, PhD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-19
Primary Completion
2023-08-31
Completion
2024-08-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03985852 on ClinicalTrials.gov