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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient navigator support
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Johns Hopkins Breast Imaging clinicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention group

Usual care group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.

Full Information

First Posted
January 4, 2022
Last Updated
July 24, 2023
Sponsor
Johns Hopkins University
Collaborators
Association of University Radiologists (AUR) - GERRAF
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1. Study Identification

Unique Protocol Identification Number
NCT05181722
Brief Title
Evaluating the Use of Patient Navigation to Promote Timely Diagnostic Evaluation During the COVID-19 Pandemic
Official Title
Evaluating the Use of Patient Navigation to Promote Timely Diagnostic Evaluation During the COVID-19 Pandemic
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
July 17, 2023 (Actual)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Association of University Radiologists (AUR) - GERRAF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study participants will be randomly assigned to either the usual care group or the intervention group.
Masking
Care ProviderInvestigator
Masking Description
The patient navigator and statistician will be unblinded to the patient groups.
Allocation
Randomized
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
The study participants in this group will receive support from the patient navigator as part of this study.
Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
The study participants in this group will receive the usual care per the institutional protocol.
Intervention Type
Other
Intervention Name(s)
Patient navigator support
Intervention Description
Support of a patient navigator for patients who have experienced an abnormal screening mammogram
Primary Outcome Measure Information:
Title
Diagnostic follow-up rates
Description
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.
Time Frame
30 days after the screening mammogram
Secondary Outcome Measure Information:
Title
Anxiety level as assessed by the Spielberger State-Trait Anxiety Inventory
Description
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).
Time Frame
1 day prior to the scheduled diagnostic appointment
Title
Breast cancer worry as assessed by the Lerman Breast Cancer Worry Scale
Description
The study participants' level of worry about breast cancer will be assessed using the 3-item Lerman Breast Cancer Worry Scale.
Time Frame
1 day prior to the scheduled diagnostic appointment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Keyes
Phone
410-550-6259
Email
akeyes1@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eniola Oluyemi
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Breast Imaging clinics
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Dalton
Phone
443-927-2859
Email
ddalton9@jhmi.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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