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

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

Recruiting
18-75 years
Female
Phase N/A

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Overview

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 cancer have a higher lifetime risk of developing it. Risk management can benefit women at high risk of breast cancer and can include surveillance routines, preventative surgeries, and medications that can dramatically lower the risk of breast cancer and allow early detection. Although risk management can benefit women at high risk of breast cancer, only a small amount actually use it. PN is a healthcare service that is designed to guide a patient through the healthcare system and reduce barriers to timely screening, follow-up, diagnosis, treatment, and supportive care. The PN intervention in this study is designed to help give women the information and support they need to make choices about their breast cancer risk that they feel good about, which may improve risk management.

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 arms.

ARM I: Participants receive links to informational websites on breast cancer risk and risk management options on study. Participants also receive phone calls from a single patient navigator and discuss breast cancer risk and risk-management options once a month for 8 months. Participants may choose to receive additional patient navigator phone calls as needed on study.

ARM II: Participants receive links to informational websites on breast cancer risk and risk management options on study.

After completion of study intervention, participants are followed for up to 1 month.

Eligibility

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

Study details
    Breast Carcinoma

NCT06950008

Ohio State University Comprehensive Cancer Center

1 February 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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