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Active, Not Recruiting

NCT Number: NCT06327074

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Hospital

Denver, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: EA-LCS

Primary outcomes

  1. Percentage of the intervention group who would like to continue the EA-LCS framework

    Time frame: 7 months

  2. Percentage of the intervention group who would recommend the EA-LCS framework to other programs

    Time frame: 7 months

  3. Percentage of participants who would describe the framework as workable

    Time frame: 7 months

Secondary outcomes

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

    Time frame: 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.

  2. Evaluate the intervention appropriateness by Intervention Appropriateness Measure (IAM)

    Time frame: 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.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

Feasibility Testing the Engaged Approach to Lung Cancer Screening

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Mar 25, 2024
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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