Status:

ACTIVE_NOT_RECRUITING

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

Lead Sponsor:

Ohio State University Comprehensive Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Breast Carcinoma

Eligibility:

FEMALE

30-64 years

Phase:

NA

Brief Summary

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...

Detailed Description

PRIMARY OBJECTIVE: I. Determine the efficacy of genetic counseling patient preference (GCPP) compared to conventional genetic counseling for adherence to National Comprehensive Cancer Network (NCCN) ...

Eligibility Criteria

Inclusion

  • Being female.
  • Ages 30-64.
  • Being an Ohio State University (OSU) patient who uses MyChart.
  • Undergoing routine screening mammography.
  • Normal BI-RADS1.
  • At elevated breast cancer risk by the Cancer Risk Assessment (CRA) tool.
  • Able to read and speak English.
  • Provide consent.

Exclusion

  • Previous genetic counseling.
  • Previous genetic testing for cancer risk or known mutation in a breast cancer gene: ATM, BARD1, BRCA1, BRCA2, CDH1, CHEK2, NBN, PALB2, PTEN, TP53.
  • Previous diagnosis of breast or ovarian cancer or personal history of lobular carcinoma in situ (LCIS) or breast hyperplasia (with or without atypia).
  • Being a member of a focus group that assisted with the development of the intervention.

Key Trial Info

Start Date :

June 13 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 30 2026

Estimated Enrollment :

874 Patients enrolled

Trial Details

Trial ID

NCT05325151

Start Date

June 13 2022

End Date

March 30 2026

Last Update

December 11 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210