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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Patient navigator support

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21093
      • Johns Hopkins Breast Imaging clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention group; The study participants in this group will receive support from the patient navigator as part of this study.	Other: Patient navigator support; Support of a patient navigator for patients who have experienced an abnormal screening mammogram
No Intervention: Usual care group; The study participants in this group will receive the usual care per the institutional protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic follow-up rates	The follow-up rates for patients with an abnormal screening mammogram will be calculated. This will be expressed as the percentage of patients who follow-up within 30 days after the abnormal screening mammogram.	30 days after the screening mammogram

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety level as assessed by the Spielberger State-Trait Anxiety Inventory	The study participants' anxiety level will be assessed using the 6-item short form of the state scale of the Spielberger State-Trait Anxiety Inventory (STAI).	1 day prior to the scheduled diagnostic appointment
Breast cancer worry as assessed by the Lerman Breast Cancer Worry Scale	The study participants' level of worry about breast cancer will be assessed using the 3-item Lerman Breast Cancer Worry Scale.	1 day prior to the scheduled diagnostic appointment

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Association of University Radiologists (AUR) - GERRAF
• Investigators: Principal Investigator: Eniola Oluyemi, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: IRB00313835

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No