Testing the Engaged Approach to Lung Cancer Screening

Not Applicable

Recruiting

• Conditions: Lung Cancer
• Interventions: Behavioral: Engaged Approach to Lung Cancer Screening

• Registration Number: NCT06327074
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-06
• Status Verified: 2024-03
• Study Start: 2024-03-11
• Study First Submitted QC: 2024-03-21
• Last Update Submitted: 2024-03-21
• Study First Posted: 2024-03-25
• Last Update Posted: 2024-03-25
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

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Exclusion Criteria

• none

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Evaluate the intervention appropriateness by Intervention Appropriateness Measure (IAM)	12 months	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.
Evaluate the intervention acceptability by Acceptability of Intervention Measure (AIM)	12 months	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.
Evaluate the intervention feasibility by Feasibility of Intervention Measure (FIM)	12 months	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.

Trial Locations

Locations (1)

University of Colorado Hospital; 🇺🇸 Denver, Colorado, United States