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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-10

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Arm I (informational websites, PN)

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.

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type OTHER

Receive links to informational websites

Patient Navigation

Intervention Type BEHAVIORAL

Receive patient navigator phone calls

Survey Administration

Intervention Type OTHER

Ancillary studies

Telephone-Based Intervention

Intervention Type BEHAVIORAL

Receive patient navigator phone calls

Arm II (informational websites)

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

Group Type ACTIVE_COMPARATOR

Educational Intervention

Intervention Type OTHER

Receive links to informational websites

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Educational Intervention

Receive links to informational websites

Intervention Type OTHER

Patient Navigation

Receive patient navigator phone calls

Intervention Type BEHAVIORAL

Survey Administration

Ancillary studies

Intervention Type OTHER

Telephone-Based Intervention

Receive patient navigator phone calls

Intervention Type BEHAVIORAL

Other Intervention Names

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Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Patient Navigator Program

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes