Improving Utilization of Lung Cancer Screening in Underserved PA Populations

Lung Cancer Clinical Trial

Official title:

Improving Utilization of Lung Cancer Screening in Underserved PA Populations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04806399
• Other study ID #: Cure 16
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: May 2024

Study information

• Verified date: April 2023
• Source: American College of Radiology
• Contact: Irene Mahon
• Phone: 215-574-3249
• Email: imahon[@]acr.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is an interventional study intended to assess the impact of a centralized outreach intervention that includes shared decision-making about lung cancer screening (LCS) in LCS-eligible primary care patients. The study's goal is to increase LCS rates compared to usual care and thus reduce lung cancer deaths.

Description:

The research team will select primary care practices included in areas where lung cancer mortality is high. An outreach registry of primary care patients obtaining care at participating practices who meet study eligibility criteria will be created from the electronic medical record. 500 primary care patients will be randomly selected for the Outreach Contact with Decision Counseling (OCDC) Group from this outreach registry. Patients targeted for inclusion in the study will have a scheduled primary care appointment 18-23 days after initial outreach contact.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: May 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 77 Years

Eligibility

Inclusion Criteria:

• Have an upcoming office visit with a primary care physician in one of the study practices

• Between the ages of 50 and 77 (inclusive)

• History of smoking (current or former) in the electronic medical record (EMR)

Exclusion Criteria:

• Chest CT performed in the last 10 months before study initiation according to EMR

• Diagnosis of lung cancer indicated in the problem list in the EMR

• Current cancer treatment or other qualifying diagnoses that would make outreach inappropriate (e.g., dementia, hearing disability)

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Educational Materials and Decision Counseling
Participants in the active comparator arm will receive an introductory letter and lung cancer screening educational materials. A site care coordinator will contact each participant post receiving materials.

Locations

Country	Name	City	State
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	Jefferson Health System	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
American College of Radiology	Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess impact of a centralized outreach intervention that includes shared decision-making (SDM) on lung cancer screening rates compared to usual care.	Implement a centralized outreach intervention that includes shared decision-making (SDM) about lung cancer screening (LCS) (screening eligibility assessment, education, and decision support) in LCS-eligible primary care patients. The study's ultimate goal is to increase LCS rates compared to usual care and thus reduce lung cancer deaths.	24 months