Testing the Engaged Approach to Lung Cancer Screening

Lung Cancer Clinical Trial

Official title:

Feasibility Testing the Engaged Approach to Lung Cancer Screening

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06327074
• Other study ID #: 21-3063.cc
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: University of Colorado, Denver
• Contact: Kaitlyn Hoover
• Phone: 7702387144
• Email: kaitlyn.hoover[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	University of Colorado Hospital	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of the intervention group who would like to continue the EA-LCS framework		7 months
Primary	Percentage of the intervention group who would recommend the EA-LCS framework to other programs		7 months
Primary	Percentage of participants who would describe the framework as workable		7 months
Secondary	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
Secondary	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
Secondary	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