Effect of Incidental Findings Information on Lung Cancer Screening Intent

Study Overview
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Brief Summary
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This online randomized controlled trial seeks to determine if inclusion of incidental findings information in a lung cancer screening decision aid affects screening intent among screening-eligible individuals. Participants will view either a decision aid with incidental findings information or without and indicate their intent to pursue lung cancer screening. Hypothesis: Inclusion of incidental findings in a decision aid will decrease intent to screen among participants.

Official Title
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Effect of Incidental Findings Information on Lung Cancer Screening Intent: A Randomized Controlled Trial

Conditions
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Neoplasm of Lung, Decision Support Techniques, Mass Screening

Intervention / Treatment
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* Behavioral: Lung Cancer Screening Decision Aid with Incidental Findings Information
* Behavioral: Lung Cancer Screening Decision Aid without Incidental Findings Information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 55-80 year old male or female Current or former smoker who quit within the last 15 years At least 30 pack years of smoking Exclusion Criteria: N/A

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decision aid with incidental findings information<br>Participants in this arm will view a video decision aid that include information on incidental findings in lung cancer screening. | Behavioral: Lung Cancer Screening Decision Aid with Incidental Findings Information<br>* The intervention consists of a previously tested and developed brief lung cancer screening video decision aid with the addition of information on incidental findings for lung cancer screening.<br>|
| Active Comparator: Decision aid without incidental findings information<br>Participants in this arm will view a video decision aid that does not include information on incidental findings in lung cancer screening. | Behavioral: Lung Cancer Screening Decision Aid without Incidental Findings Information<br>* The intervention consists of a previously tested and developed brief lung cancer screening video decision aid that does not include information on incidental findings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of individuals who plan to pursue lung cancer screening | This will be assessed by a survey item where participants indicate their response to a statement of whether they plan to pursue lung cancer screening, with answer choices being strongly agree, agree, disagree and strongly disagree. Comparison between the intervention and control groups will be made. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean score on scale of lung cancer screening knowledge | Lung cancer screening knowledge tested by 6 multiple choice questions on facts of the benefit and harms of screening. The questions will be answered before and after participants watch a lung cancer screening decision aid. Scores will be determined by the number of correct answers for questions. | Day 1 | 
| Mean rating of benefit and harms of screening | Participants will rate (Likert 1-5 scale with 1 being less important and 5 being more important) 6 lung cancer screening benefits and harms on importance to them. | Day 1 | 
| Percentage of Time Lung Cancer Screening Benefit and Harms are ranked first and last | Participants will rank six lung cancer screening benefits and harms. | Day 1 | 
| Mean ranking of benefit and harms of screening | Participants will rank six lung cancer screening benefits and harms. | Day 1 | 
| Percentage of time each lung cancer screening harm is ranked highest of the five potential harms | Participants will rank six lung cancer screening benefits and harms. | Day 1 | 
| Mean ranking of incidental findings attribute | Participants will rank six lung cancer screening benefits and harms, including one on incidental findings. Comparison of mean ranking will be made between the intervention and control groups. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incidental Findings