Testing the Engaged Approach to Lung Cancer Screening
Feasibility Testing the Engaged Approach to Lung Cancer Screening
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Colorado
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Denver, Colorado, United States, 80045
- University of Colorado Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: 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.
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Experimental: 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.
|
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:
Candidate-facing materials include:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of the intervention group who would like to continue the EA-LCS framework
Time Frame: 7 months
|
7 months
|
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Percentage of the intervention group who would recommend the EA-LCS framework to other programs
Time Frame: 7 months
|
7 months
|
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Percentage of participants who would describe the framework as workable
Time Frame: 7 months
|
7 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate the intervention acceptability by Acceptability of Intervention Measure (AIM)
Time Frame: 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. |
12 months
|
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Evaluate the intervention appropriateness by Intervention Appropriateness Measure (IAM)
Time Frame: 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. |
12 months
|
|
Evaluate the intervention feasibility by Feasibility of Intervention Measure (FIM)
Time Frame: 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. |
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jamie Studts, PhD, University of Colorado, Denver
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-3063.cc
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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