Improving Utilization of Lung Cancer Screening in Underserved PA Populations

October 11, 2024 updated by: American College of Radiology
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

2500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18105
        • Lehigh Valley Health Network
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care Control Group
Active Comparator: Outreach Contact with Decision Counseling Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess impact of a centralized outreach intervention that includes shared decision-making (SDM) on lung cancer screening rates compared to usual care.
Time Frame: 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American College of Radiology

Collaborators

Thomas Jefferson University

Investigators

  • Study Chair: Ronald Myers, PhD, Jefferson Health System
  • Principal Investigator: Etta Pisano, MD, American College of Radiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

January 8, 2021

First Submitted That Met QC Criteria

March 16, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 11, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cure 16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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