Clinical trial NCT05181722: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Association of University Radiologists (AUR) - GERRAF
First posted: 2022-01-06
Enrollment: 196
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study participants will be randomly assigned to either the usual care group or the intervention group.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Diagnostic follow-up rates
timeFrame: 30 days after the screening mammogram
Secondary outcomes:
measure: Anxiety level as assessed by the Spielberger State-Trait Anxiety Inventory
timeFrame: 1 day prior to the scheduled diagnostic appointment
measure: Breast cancer worry as assessed by the Lerman Breast Cancer Worry Scale
timeFrame: 1 day prior to the scheduled diagnostic appointment
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Breast Imaging clinics
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Eniola Oluyemi
role: PRINCIPAL_INVESTIGATOR
References: