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Active, not recruiting Not applicable Interventional Accepts healthy volunteers

Genetic Counseling Patient Preference Intervention Versus Conventional Genetic Counseling for Women at Elevated Risk for Breast Cancer

ClinicalTrials.gov ID: NCT05325151

Public ClinicalTrials.gov record NCT05325151. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 3:50 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized Controlled Trial Comparing a Genetic Counseling Patient Preference Intervention vs. Conventional Genetic Counseling for Women at Elevated Risk for Breast Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This stage I clinical trial compares a genetic counseling patient preference (GCPP) intervention via EHR MyChart patient portal to conventional genetic counseling for women at elevated risk for breast cancer. Women at elevated breast cancer risk may be offered genetic counseling and genetic testing to further define whether they are at high risk (e.g. hereditary risk; BRCA mutation positive); moderate risk (e.g. risk based largely on family history and/or polygenic risk score) or average risk (e.g. general population). Genetic counseling may improve basic genetic knowledge, produce more accurate risk perceptions and tailor recommendations for greater perceived personal control regarding breast cancer risk. A single approach to genetic counseling may not fit the needs for all patients, and genetic counseling models that increase access to genetic testing and are more patient-centered may better serve patients. This trial may help researchers determine if a GCPP intervention can take the place of conventional genetic counseling, while being non-inferior in terms of adherence to screening recommendations, breast cancer genetic knowledge, accurate perception of risk, breast cancer-specific worry, and satisfaction with counseling compared to conventional genetic counseling. Study results will provide the efficacy for using a novel cancer genetic counseling approach via EHR MyChart patient portal that will be readily adaptable to other health care systems in the future, inform best practices, and reduce workforce burden.

Study identification

NCT ID
NCT05325151
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Enrollment
874 participants

Conditions and interventions

Eligibility (public fields only)

Age range
30 Years to 64 Years
Sex
Female
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 12, 2022
Primary completion
Mar 29, 2026
Completion
Sep 29, 2026
Last update posted
Jul 5, 2026

2022 – 2026

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Ohio State University Comprehensive Cancer Center Columbus Ohio 43210

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05325151, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 5, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05325151 live on ClinicalTrials.gov.

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