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

NCT05181722 | Active Not Recruiting DMC

• 1 other identifier: IRB00313835
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Anxiety level as assessed by the Spielberger State-Trait Anxiety Inventory

  1 day prior to the scheduled diagnostic appointment

• Breast cancer worry as assessed by the Lerman Breast Cancer Worry Scale

  1 day prior to the scheduled diagnostic appointment

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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

Other: Patient navigator support

Usual care group

NO INTERVENTION

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

Interventions

Patient navigator support OTHER

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any study participant who is unable to provide consent to participate in the study will be excluded.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Association of University Radiologists (AUR) - GERRAF: collaborator

Study Sites (1)

Johns Hopkins Breast Imaging clinics

Baltimore, Maryland, 21093, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Eniola Oluyemi

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The patient navigator and statistician will be unblinded to the patient groups.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study participants will be randomly assigned to either the usual care group or the intervention group.

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 6, 2022
• Study Start: July 18, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)