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NCT Number: NCT05181722

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Breast Imaging clinics

Baltimore, Maryland, 21093, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patient navigator support

Other

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

Primary outcomes

  1. Diagnostic follow-up rates

    Time frame: 30 days after the screening mammogram

    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.

Secondary outcomes

  1. Anxiety level as assessed by the Spielberger State-Trait Anxiety Inventory

    Time frame: 1 day prior to the scheduled diagnostic appointment

    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).

  2. Breast cancer worry as assessed by the Lerman Breast Cancer Worry Scale

    Time frame: 1 day prior to the scheduled diagnostic appointment

    The study participants' level of worry about breast cancer will be assessed using the 3-item Lerman Breast Cancer Worry Scale.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Association of University Radiologists (AUR) - GERRAF

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2022
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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