Patient Navigation for Breast Cancer Risk Management
This study is looking at whether a "patient navigation" (PN) program can help women at high risk for breast cancer better manage their risk. Many women at high risk don't use important risk management strategies like screenings or preventative medicines. Patient navigation is a service that guides you through the healthcare system, helping you overcome barriers to getting the care you need. You may be able to join if you are a non-Hispanic Black or non-Hispanic white woman between 18 and 75 years old, have never had breast or ovarian cancer, and are just starting to learn about breast cancer risk management. The study will measure how satisfied participants are with the PN program and how well the program is put into practice. The current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 75 participants. Participants will be randomly assigned to one of two groups.
- What's involved
- Participants in one group will receive links to informational websites and monthly phone calls from a patient navigator for 8 months. The other group will receive only links to informational websites.
- Compensation
- Not stated in the trial record.
- Follow-up
- After the study intervention, participants will be followed for up to 1 month.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Patient Navigation Intervention for the Improvement of Risk Management Among Women at High Risk of Breast Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Tasleem J Padamsee, PhD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Participant satisfaction with patient navigation (PN) intervention (Feasibility)Up to 9 months
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.
- Demand measures (Feasibility)Up to 9 months
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.
- Implementation of PN intervention (Feasibility)Up to 9 months
Number of calls and patient navigator (PN contacts.
- Practicality of PN intervention (Feasibility)Up to 9 months
Percentage of participants that assess the intervention as appropriate and are willing to recommend it for similar others.
- Percentage of recruited individuals who eventually enroll (Feasibility)Up to 6 months
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.
- Risk-management adoption pathway (R-MAP) progressBaseline up to 9 months
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.
- Perceived Breast Cancer RiskUp to 9 months
The percentage of participants with perceived breast cancer risk indicated by survey responses will be summarized.
- Cancer WorryUp to 9 months
The percentage of participants with cancer worry indicated by survey responses will be summarized.
- Confidence in Coping with Breast Cancer RiskUp to 9 months
The percentage of participants with confidence in coping with breast cancer risk indicated by survey responses will be summarized.
- Belief that Breast Cancer Risk can be ReducedUp to 9 months
The percentage of participants with belief that their breast cancer risk can be reduced indicated by survey responses will be summarized.
- Mental HealthUp to 9 months
Will be assessed via a 5-item inventory at baseline and final surveys.
- Information usage (Self-reported)Up to 9 months
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.
- Information usage (Machine-recorded)Up to 9 months
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.