Pre-Post Study for Supporting Appropriate Implementation of Lung Cancer Screening

Study Overview
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Brief Summary
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The primary objective of this study is to assess the effect of the decision aid on measures of decision-making such as knowledge, screening attitudes, decisional conflict, and screening intent.

Detailed Description
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Using a single group, pre-post design, we aim to assess the effect of the decision aid on screening knowledge, screening attitudes, decisional conflict, and screening intent within 3 months of decision aid viewing.

Official Title
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Pre-Post Study for Supporting Appropriate Implementation of Lung Cancer Screening

Conditions
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Lung Neoplasms, Early Detection of Cancer, Decision Support Techniques, Primary Health Care

Intervention / Treatment
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* Behavioral: Pre/Post Test of a Lung Cancer Screening Decision Aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must meet all of the following inclusion criteria to participate in this study: Age 55 - 80; Current smoker, or former smoker who has less than a 16-year quit history; Have at least a 30-pack year smoking history (average packs per day * years smoking); and Patient of the Internal Medicine Clinic at University of North Carolina Health Care. Exclusion Criteria: All subjects meeting any of the following exclusion criteria at baseline will be excluded from study participation: Ever diagnosed with lung cancer; Undergone chemotherapy or radiation therapy in the past 18 months prior to enrollment; Coughed up blood from lungs (also called hemoptysis) within the past year prior to enrollment; Experienced unexplained weight loss of 15-pounds or more during six months prior to enrollment; and Had a chest CT scan within the past 18 months prior to enrollment.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre/Post Test of a Lung Cancer Screening Decision Aid<br> | Behavioral: Pre/Post Test of a Lung Cancer Screening Decision Aid<br>* After completing the baseline survey, the research team member will ask each participant asked to view the lung cancer screening decision aid on a tablet. The following areas regarding lung cancer screening: What is lung cancer?, Why is lung cancer a problem?, What is screening?, What is low-dose CT screening, Recommended frequency of screening, Screening factors, lung cancer risks and benefits (magnitude of benefit, harms, false positive, invasive procedures, radiation, stress/anxiety), Summary, Values Clarification, Screening Choice, and Smoking cessation messaging for current smokers OR positive reinforcement for former smokers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in decision-making measures of knowledge | We will use descriptive statistics to provide an overview of knowledge at baseline and at follow-up. Hypothesis 1: Screening specific knowledge will improve after completing the decision aid. o Statistical tests: Overall knowledge: Treating knowledge as a continuous variable by adding number correct out of 12 items (0-12 possible points), we will perform a Wilcoxon sign rank test to assess change in knowledge between baseline and follow-up Individual knowledge items: Using McNemar's test, we will compare the proportion who correctly answered individual knowledge items at baseline and follow-up | At time of intervention | 
| Change in screening attitudes | We will use descriptive statistics to provide an overview of screening attitudes at baseline and at follow-up. • Exploratory: Using t-tests or chi-squared tests as appropriate, we will assess the change between baseline and follow-up of screening attitudes. | At time of intervention | 
| Change in decisional conflict | We will use descriptive statistics to provide an overview of decisional conflict at baseline and at follow-up. • Exploratory: Using t-tests or chi-squared tests as appropriate, we will assess the change between baseline and follow-up of decisional conflict. | At time of intervention | 
| Change in screening intentions | We will use descriptive statistics to provide an overview of screening intentions at baseline and at follow-up. • Exploratory: Using t-tests or chi-squared tests as appropriate, we will assess the change between baseline and follow-up of screening intentions. | At time of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preliminary estimates on the effect of the decision aid on behavioral outcomes | We will use descriptive statistics (means and proportions) to provide preliminary estimates on the effect of the decision aid on documentation of shared decision-making in the electronic health record and screening behavior at 3 months. | Within 3 months of intervention | 
| Feasibility of implementing a decision aid intervention in a primary care clinic setting | This is a descriptive and qualitative aim. We will describe measures of feasibility related to time needed to complete surveys, participant ability to navigate decision aid website, number of times assistance is needed to complete surveys/navigate the decision aid website, and type of assistance required. | Through study completion, an average of 1 year |