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Trial Title:
Testing the Engaged Approach to Lung Cancer Screening
NCT ID:
NCT06327074
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Engaged Approach to Lung Cancer Screening
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.
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
Arm group label:
Experimental Group
Other name:
EA-LCS
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Colorado Hospital
Address:
City:
Denver
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jamie Studts
Email:
Jamie.Studts@CUANSCHUTZ.EDU
Contact backup:
Last name:
Jamie Studts, PhD
Contact backup:
Last name:
Erin Hirsch
Start date:
March 11, 2024
Completion date:
December 2026
Lead sponsor:
Agency:
University of Colorado, Denver
Agency class:
Other
Collaborator:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Source:
University of Colorado, Denver
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06327074