A Patient Navigation Intervention for the Improvement of Risk Management Among Women at High Risk of Breast Cancer
Purpose
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.
Condition
- Breast Carcinoma
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
Criteria
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
|
Active Comparator Arm II (informational websites) |
Participants receive links to informational websites on breast cancer risk and risk management options on study. |
|
Recruiting Locations
Columbus, Ohio 43210
More Details
- NCT ID
- NCT06950008
- Status
- Recruiting
- Sponsor
- Ohio State University Comprehensive Cancer Center
Study Contact
The Ohio State University Comprehensive Cancer Center800-293-5066
OSUCCCClinicaltrials@osumc.edu
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.