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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Carcinoma
• Intervention / Treatment: Other: Survey Administration; Other: Educational Intervention; Behavioral: Patient Navigation; Behavioral: Telephone-Based Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Survey Administration; Ancillary studies; Other: Educational Intervention; Receive links to informational websites; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Behavioral: Patient Navigation; Receive patient navigator phone calls; Other Names: Patient Navigator Program; Behavioral: Telephone-Based Intervention; Receive patient navigator phone calls
Active Comparator: Arm II (informational websites); Participants receive links to informational websites on breast cancer risk and risk management options on study.	Other: Survey Administration; Ancillary studies; Other: Educational Intervention; Receive links to informational websites; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant satisfaction with patient navigation (PN) intervention (Feasibility)	Will be measured using previously validated survey questions related to patient navigation interactions. Will be defined as at least 50% of intervention arm participants are "satisfied" or "very satisfied" with the PN intervention. Will be formally assessed using a point estimate and 95% one-sided (score-based) confidence interval.	Up to 9 months
Demand measures (Feasibility)	Measures the use of the patient navigator (PN). Will check that at least 50% of the sample interacted with the patient navigator for a total of at least 15 minutes.	Up to 9 months
Implementation of PN intervention (Feasibility)	Number of calls and patient navigator (PN contacts.	Up to 9 months
Practicality of PN intervention (Feasibility)	Percentage of participants that assess the intervention as appropriate and are willing to recommend it for similar others.	Up to 9 months
Percentage of recruited individuals who eventually enroll (Feasibility)	Will be tracked to help determine the feasibility of attracting appropriate sample sizes to power a later effectiveness-oriented randomized controlled trial. Recruitment success will be indicated by enrollment of ≥ 20% recruited patients and a total of 75 in 6 months. Point estimates for other key measures will be used as supporting evidence of intervention feasibility.	Up to 6 months
Risk-management adoption pathway (R-MAP) progress	Will descriptively estimate progress in R-MAP stage for each recommended risk-management action, as well as estimate change in other R-MAP measures between baseline and final surveys. Differences in R-MAP progress and other measures described will be estimated between arms at the final time point. Will regard the intervention as worthy of further effectiveness testing if the difference in R-MAP stage between intervention and control arm participants is ≥ .5 points (on the 6-point measurement scale) and ≥ 15% for at least one risk-management action.	Baseline up to 9 months
Perceived Breast Cancer Risk	The percentage of participants with perceived breast cancer risk indicated by survey responses will be summarized.	Up to 9 months
Cancer Worry	The percentage of participants with cancer worry indicated by survey responses will be summarized.	Up to 9 months
Confidence in Coping with Breast Cancer Risk	The percentage of participants with confidence in coping with breast cancer risk indicated by survey responses will be summarized.	Up to 9 months
Belief that Breast Cancer Risk can be Reduced	The percentage of participants with belief that their breast cancer risk can be reduced indicated by survey responses will be summarized.	Up to 9 months
Mental Health	Will be assessed via a 5-item inventory at baseline and final surveys.	Up to 9 months
Information usage (Self-reported)	Self-reported usage of the provided informational websites by the control group will be measured. Number of visits to the informational websites will be summarized.	Up to 9 months
Information usage (Machine-recorded)	Machine-recorded usage of the provided informational websites by the control group will be measured. Usage will be recorded by tracking the use of the bitly links provided. The number of visits to each informational website will be summarized.	Up to 9 months

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Tasleem J Padamsee, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Health Services Administration; Investigative Techniques; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Patient Care Management; Comprehensive Health Care; Patient-Centered Care; Primary Health Care; Methods; Early Intervention, Educational; Educational Status; Patient Navigation
• Other Study ID Numbers: OSU-24198; NCI-2025-01592 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R21CA271070 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No