NCT05181722

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	Patient navigator support	Support of a patient navigator for patients who have experienced an abnormal screening mammogram

Timeline

• Start date: 2022-07-18
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-01-06
• Last updated: 2025-12-24

Locations

1 site across 1 country: United States