Testing the Engaged Approach to Lung Cancer Screening

NCT06327074 | Active Not Recruiting DMC

• 1 other identifier: 21-3063.cc
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Evaluate the intervention acceptability by Acceptability of Intervention Measure (AIM)

  12 months

• Evaluate the intervention appropriateness by Intervention Appropriateness Measure (IAM)

  12 months

• Evaluate the intervention feasibility by Feasibility of Intervention Measure (FIM)

  12 months

Study Arms (2)

Control Group

NO INTERVENTION

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 Group

EXPERIMENTAL

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

Interventions

Engaged Approach to Lung Cancer Screening BEHAVIORAL

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

Also known as: EA-LCS

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)
• 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

You may not qualify if:

• none

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

University of Colorado Hospital

Denver, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jamie Studts, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: March 25, 2024
• Study Start: March 11, 2024
• Primary Completion: October 30, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)