Lung Cancer
Conditions
Brief 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.
Interventions
BEHAVIORALEngaged 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
Sponsors
Bristol-Myers Squibb
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of the intervention group who would like to continue the EA-LCS framework | 7 months |
| Percentage of the intervention group who would recommend the EA-LCS framework to other programs | 7 months |
| Percentage of participants who would describe the framework as workable | 7 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the intervention acceptability by Acceptability of Intervention Measure (AIM) | 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. |
| Evaluate the intervention appropriateness by Intervention Appropriateness Measure (IAM) | 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. |
| Evaluate the intervention feasibility by Feasibility of Intervention Measure (FIM) | 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. |
Countries
United States
Outcome results
None listed