CompletedNot Applicable

Evaluating the Use of Patient Navigation to Promote Timely Diagnostic Evaluation During the COVID-19 Pandemic

United States126 participantsStarted 2022-07-18

Plain-language summary

The primary objective of this project is to evaluate the role of patient navigation in promoting timely follow-up of abnormal breast imaging findings in patient populations that have been most severely impacted by the novel coronavirus (COVID-19) pandemic. This project aims to assess the impact of patient navigation as an intervention tool in patient populations that are most at risk for delayed follow-up. The investigators hypothesize that patient navigation services may be an effective way to mitigate the impact of the pandemic by decreasing the risk of a delayed breast cancer diagnosis and promoting timely diagnostic follow-up.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients who have an abnormal screening mammogram (i.e. given a Breast Imaging-Reporting and Data System \[BI-RADS\] assessment category of 0) at the investigators' institution during the study period and have not yet undergone diagnostic evaluation Exclusion Criteria: * Any study participant who is unable to provide consent to participate in the study will be excluded.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Diagnostic follow-up rates

Timeframe: 30 days after the screening mammogram

Trial details

NCT IDNCT05181722

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-27

View on ClinicalTrials.gov More Breast Cancer trials