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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

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