Breast Cancer Clinical Trial
Official title:
Evaluating the Use of Patient Navigation to Promote Timely Diagnostic Evaluation During the COVID-19 Pandemic
NCT number | NCT05181722 |
Other study ID # | IRB00313835 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 18, 2022 |
Est. completion date | June 2024 |
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.
Status | Recruiting |
Enrollment | 196 |
Est. completion date | June 2024 |
Est. primary completion date | July 17, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Breast Imaging clinics | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Association of University Radiologists (AUR) - GERRAF |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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). | 1 day prior to the scheduled diagnostic appointment | |
Secondary | 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. | 1 day prior to the scheduled diagnostic appointment |
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