Testing the Engaged Approach to Lung Cancer Screening

Feasibility Testing the Engaged Approach to Lung Cancer Screening

The goal of this study is to assess feasibility and acceptability of the Engaged Approach to Lung Cancer Screening (EA-LCS) in diverse lung cancer screening (LCS) programs operating in a variety of geographic regions across Colorado and the US.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: Engaged Approach to Lung Cancer Screening

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80045
      • University of Colorado Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

The trial incorporates a multilevel assessment and enrollment involves inclusion criteria at two levels: (1) LCS Program and (2) LCS Program Staff member.

Program inclusion criteria (n = up to 8 sites):

• Must conduct at least 50 low-dose computed tomography (LDCT) scans per year (baseline + follow-up)
• Must be able to identify a primary contact person for LCS program operations (e.g., program coordinator, program navigator, program manager, etc.)

Staff member inclusion criteria (n ~ 5 at each site/~40 participants total):

• Identified staff member of the LCS program site
• >18 years of age
• Must be able to complete study surveys and interviews in English
• Willing to provide informed consent

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; Sites in the control condition will be asked to complete appropriate/relevant surveys and interviews with minor modifications as needed and use the same Electronic Health Record Data Abstraction process.
Experimental: Experimental Group; Sites randomized to use the EA-LCS materials will be given password-protected access to the program/toolkit web portal and encouraged to use any materials that fit the normal flow of clinic procedures. Materials available include both staff-facing and LCS candidate-facing materials.	Behavioral: Engaged Approach to Lung Cancer Screening; Sites randomized to use the EA-LCS materials will be given password-protected access to the program/toolkit web portal and encouraged to use any materials that fit the normal flow of clinic procedures. Materials available include both staff-facing and LCS candidate-facing materials. Staff-facing materials include: Program website/manual/toolkit overview; Implementation insights with experts video series; Clinical placement placards; Program and clinician communication tools Candidate-facing materials include: Program welcome letter; Maps and directions template; Communication preferences; Candidate letter templates (N=~8); Program newsletter template and instructions; Lung nodule size comparison chart; Other Names: EA-LCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of the intervention group who would like to continue the EA-LCS framework	7 months
Percentage of the intervention group who would recommend the EA-LCS framework to other programs	7 months
Percentage of participants who would describe the framework as workable	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the intervention acceptability by Acceptability of Intervention Measure (AIM)	Indexes of intervention acceptability will be measured by the Acceptability of Intervention Measure (AIM). A 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean.	12 months
Evaluate the intervention appropriateness by Intervention Appropriateness Measure (IAM)	Indexes of intervention appropriateness will be measured by the Intervention Appropriateness Measure (IAM). A 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean.	12 months
Evaluate the intervention feasibility by Feasibility of Intervention Measure (FIM)	Indexes of intervention feasibility will be measured by the Feasibility of Intervention Measure (FIM). A 4-item measure of perceived intervention acceptability. Items are measured on a 5-point Likert scale (Completely Disagree-Completely Agree). Score is calculated mean.	12 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: Jamie Studts, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Actual): October 30, 2024
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 6, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 21-3063.cc

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
• product manufactured in and exported from the U.S.: No