Testing the Engaged Approach to Lung Cancer Screening

NCT ID: NCT06327074

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-11

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Engaged Approach to Lung Cancer Screening

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

Other Intervention Names

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EA-LCS

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jamie Studts, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Hospital

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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21-3063.cc

Identifier Type: -

Identifier Source: org_study_id