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Patient Navigation for Timely Breast Cancer Diagnosis During COVID-19

N/A
Waitlist Available
Led By Eniola Oluyemi
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days after the screening mammogram
Awards & highlights
No Placebo-Only Group

Summary

This trial will evaluate whether patient navigation can help reduce delays in breast cancer diagnosis caused by the COVID-19 pandemic.

Who is the study for?
This trial is for patients with abnormal breast screening results during the COVID-19 pandemic who haven't had further diagnostic evaluation. It's aimed at those most affected by delays in follow-up due to the pandemic. Participants must be able to give consent.
What is being tested?
The study is testing if patient navigator support can help people get timely follow-up care after an abnormal mammogram, especially during the disruptions caused by COVID-19. The goal is to see if this support reduces delays in diagnosing breast cancer.
What are the potential side effects?
Since this trial involves patient navigation rather than a medical treatment or drug, there are no direct side effects associated with it like you might expect from medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My recent mammogram was abnormal, and I haven't had further tests yet.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after the screening mammogram
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after the screening mammogram for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Diagnostic follow-up rates
Secondary study objectives
Anxiety level as assessed by the Spielberger State-Trait Anxiety Inventory
Breast cancer worry as assessed by the Lerman Breast Cancer Worry Scale

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Usual care groupActive Control1 Intervention
The study participants in this group will receive the usual care per the institutional protocol.
Group II: Intervention groupActive Control1 Intervention
The study participants in this group will receive support from the patient navigator as part of this study.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,326 Previous Clinical Trials
14,874,763 Total Patients Enrolled
28 Trials studying Breast Cancer
23,355 Patients Enrolled for Breast Cancer
Association of University Radiologists (AUR) - GERRAFUNKNOWN
Eniola OluyemiPrincipal InvestigatorJohns Hopkins University

Media Library

Intervention group Clinical Trial Eligibility Overview. Trial Name: NCT05181722 — N/A
Breast Cancer Research Study Groups: Usual care group, Intervention group
Breast Cancer Clinical Trial 2023: Intervention group Highlights & Side Effects. Trial Name: NCT05181722 — N/A
Intervention group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05181722 — N/A
~35 spots leftby Jun 2025
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