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

NCT ID: NCT05181722

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-18

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Patients who meet the study selection criteria will be randomized into two groups in a 1:1 ratio: the usual care group and the intervention group. Initially, patients will be invited to participate in the study via a brief statement included in the patient result letter informing patients of their abnormal screening mammogram result. The patient navigator will then follow up with each patient who expresses interest in the study via telephone to reiterate the details of the project, answer any questions that the patients might have, and invite the patients to participate in the project if the patients meet the study inclusion criteria. Informed consent will be obtained from the study participants.

The primary role of the patient navigator will be to identify and address barriers to accessing timely diagnostic care. The patient navigator's duties will also include providing an array of services aimed at improving health care access and engagement, including appointment reminder phone calls, health education, assistance with scheduling appointments, providing information about available transportation options to the clinic sites (e.g., shuttle service provided by the institution), helping patients to connect with language interpretation services, providing assistance with resolving insurance issues, and motivating and coaching patients on the importance of timely follow-up of abnormal breast imaging results. The services provided by the patient navigator will be tailored to the specific needs of each patient and will be aimed at helping patients to overcome personal, cultural and systemic barriers to successfully completing follow-up.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Study participants will be randomly assigned to either the usual care group or the intervention group.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Caregivers Investigators
The patient navigator and statistician will be unblinded to the patient groups.

Study Groups

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Usual care group

The study participants in this group will receive the usual care per the institutional protocol.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

The study participants in this group will receive support from the patient navigator as part of this study.

Group Type ACTIVE_COMPARATOR

Patient navigator support

Intervention Type OTHER

Support of a patient navigator for patients who have experienced an abnormal screening mammogram

Interventions

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Patient navigator support

Support of a patient navigator for patients who have experienced an abnormal screening mammogram

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Association of University Radiologists (AUR) - GERRAF

UNKNOWN

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eniola Oluyemi

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Breast Imaging clinics

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00313835

Identifier Type: -

Identifier Source: org_study_id