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Active, not recruitingNCT04806399Updated Oct 15, 2024

Improving Utilization of Lung Cancer Screening in Underserved PA Populations

An interventional study of Educational Materials and Decision Counseling in Lung Cancer, sponsored by American College of Radiology. Active, not recruiting at 2 sites in United States. Open to participants aged 50 Years to 77 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by American College of Radiology · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
2,500
Allocation
Randomized
Ages
50 Years to 77 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lung Cancer

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Keywords

  • Screening Utilization
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 2,500 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

American College of Radiology is the lead sponsor of 14 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 77 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,500 participants (estimated)

Study arms

  • No intervention
    Usual Care Control Group
  • Active comparator
    Outreach Contact with Decision Counseling Group

    Other: Educational Materials and Decision Counseling

Interventions

  • OtherEducational 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 months

07

Study locations

2 sites
  • Lehigh Valley Health Network
    Allentown, Pennsylvania 18105, United States
  • Jefferson Health System
    Philadelphia, Pennsylvania 19107, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04806399
Lead sponsor
American College of Radiology
Collaborators
Thomas Jefferson University
Responsible party
Sponsor
First posted
Mar 19, 2021
Start date
Mar 30, 2023
Primary completion
Nov 2024 (estimated)
Completion
Nov 2024 (estimated)
Last update
Oct 15, 2024

Study contacts

Etta Pisano, MD
principal investigator · American College of Radiology
Ronald Myers, PhD
study chair · Jefferson Health System

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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