Clinical trial NCT06950008: A Patient Navigation Intervention for the Improvement of Risk Management Among Women at High Risk of Breast Cancer
Official title: Feasibility Testing of a Patient Navigation Intervention to Improve Risk Management Among Women at High Risk of Breast Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-04-29
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Participant satisfaction with patient navigation (PN) intervention (Feasibility)
timeFrame: Up to 9 months
measure: Demand measures (Feasibility)
timeFrame: Up to 9 months
measure: Implementation of PN intervention (Feasibility)
timeFrame: Up to 9 months
measure: Practicality of PN intervention (Feasibility)
timeFrame: Up to 9 months
measure: Percentage of recruited individuals who eventually enroll (Feasibility)
timeFrame: Up to 6 months
measure: Risk-management adoption pathway (R-MAP) progress
timeFrame: Baseline up to 9 months
measure: Perceived Breast Cancer Risk
timeFrame: Up to 9 months
measure: Cancer Worry
timeFrame: Up to 9 months
measure: Confidence in Coping with Breast Cancer Risk
timeFrame: Up to 9 months
measure: Belief that Breast Cancer Risk can be Reduced
timeFrame: Up to 9 months
measure: Mental Health
timeFrame: Up to 9 months
measure: Information usage (Self-reported)
timeFrame: Up to 9 months
measure: Information usage (Machine-recorded)
timeFrame: Up to 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Tasleem J Padamsee, PhD
role: PRINCIPAL_INVESTIGATOR
References: