NCT06950008

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

Feasibility Testing of a Patient Navigation Intervention to Improve Risk Management Among Women at High Risk of Breast Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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 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.

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 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

• Breast Carcinoma

Interventions

Type	Name	Description
OTHER	Educational Intervention	Receive links to informational websites
BEHAVIORAL	Patient Navigation	Receive patient navigator phone calls
OTHER	Survey Administration	Ancillary studies
BEHAVIORAL	Telephone-Based Intervention	Receive patient navigator phone calls

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-01-31
• Completion: 2027-01-31
• First posted: 2025-04-29
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States