Testing the Engaged Approach to Lung Cancer Screening

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Lung Cancer

Treatments: Behavioral: Engaged Approach to Lung Cancer Screening

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06327074

21-3063.cc

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Control Group

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Engaged Approach to Lung Cancer Screening