Status:

RECRUITING

A Patient Navigation Intervention for the Improvement of Risk Management Among Women at High Risk of Breast Cancer

Lead Sponsor:

Ohio State University Comprehensive Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Breast Carcinoma

Eligibility:

FEMALE

18-75 years

Phase:

NA

Brief Summary

This clinical trial studies whether a patient navigation (PN) intervention can be used to improve risk management among women at high risk of breast cancer. Women with a family history of breast cance...

Detailed Description

PRIMARY OBJECTIVE: I. Test the feasibility of the PN intervention and of recruiting participants to a randomized controlled trial of the intervention. OUTLINE: Participants are randomized to 1 of 2 ...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Are non-Hispanic Black or non-Hispanic white
  • Identify as women
  • Are between 18 and 75 years old
  • Have been identified as at potentially high risk by a population-based risk screening program
  • Have never been diagnosed with breast or ovarian cancer
  • Are early in their risk-management adoption process, defined as currently identifying with stage 0 (never heard of it) or 1 (haven't decided) of the risk-management adoption pathway (R-MAP) in relation to at least one of the four risk-management actions recommended for all high-risk women: attending genetic counseling appointment, having a personalized risk assessment, undergoing annual clinical breast exams, and considering chemoprevention
  • Who do not believe cancer can be prevented and/or have not received risk-management guidance from a specialist

Exclusion

    Key Trial Info

    Start Date :

    January 10 2026

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 31 2026

    Estimated Enrollment :

    75 Patients enrolled

    Trial Details

    Trial ID

    NCT06950008

    Start Date

    January 10 2026

    End Date

    December 31 2026

    Last Update

    November 26 2025

    Active Locations (1)

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    Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, United States, 43210

    A Patient Navigation Intervention for the Improvement of Risk Management Among Women at High Risk of Breast Cancer | DecenTrialz