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Patient Navigation for Timely Breast Cancer Diagnosis During COVID-19
N/A
Recruiting
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My recent mammogram was abnormal, and I haven't had further tests yet.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days after the screening mammogram
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days after the screening mammogram
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Diagnostic follow-up rates
Secondary outcome measures
Anxiety level as assessed by the Spielberger State-Trait Anxiety Inventory
Breast cancer worry as assessed by the Lerman Breast Cancer Worry Scale
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.
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,262 Previous Clinical Trials
14,822,968 Total Patients Enrolled
27 Trials studying Breast Cancer
23,312 Patients Enrolled for Breast Cancer
Association of University Radiologists (AUR) - GERRAFUNKNOWN
Eniola OluyemiPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My recent mammogram was abnormal, and I haven't had further tests yet.
Research Study Groups:
This trial has the following groups:- Group 1: Usual care group
- Group 2: Intervention group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are involved in this clinical research project?
"Affirmative. Clinicaltrials.gov data confirms that this research endeavour, which was originally posted on July 18th 2022, is presently recruiting for 196 participants from a single site."
Answered by AI
Are there opportunities for individuals to participate in this experiment?
"According to clinicaltrials.gov, this trial is open for recruitment as of today. It was originally advertised on July 18th 2022 and the information concerning it has been recently refreshed on July 28th 2022."
Answered by AI
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