Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 9:08 PM
Study NCT ID:
NCT06950008
Status:
RECRUITING
Last Update Posted:
2025-11-26
First Post:
2025-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Patient Navigation Intervention for the Improvement of Risk Management Among Women at High Risk of Breast Cancer
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Feasibility Testing of a Patient Navigation Intervention to Improve Risk Management Among Women at High Risk of Breast Cancer
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-01592 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| R21CA271070 | NIH | None | https://reporter.nih.gov/quic… | View |