- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04432753
Effect of Incidental Findings Information on Lung Cancer Screening Intent
Effect of Incidental Findings Information on Lung Cancer Screening Intent: A Randomized Controlled Trial
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- University of North Carolina at Chapel Hill
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Decision aid with incidental findings information
Participants in this arm will view a video decision aid that include information on incidental findings in lung cancer screening.
|
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.
|
Active Comparator: Decision aid without incidental findings information
Participants in this arm will view a video decision aid that does not include information on incidental findings in lung cancer screening.
|
The intervention consists of a previously tested and developed brief lung cancer screening video decision aid that does not include information on incidental findings.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of individuals who plan to pursue lung cancer screening
Time Frame: Day 1
|
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
Time Frame: Day 1
|
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
Time Frame: Day 1
|
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
Time Frame: Day 1
|
Participants will rank six lung cancer screening benefits and harms.
|
Day 1
|
Mean ranking of benefit and harms of screening
Time Frame: Day 1
|
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
Time Frame: Day 1
|
Participants will rank six lung cancer screening benefits and harms.
|
Day 1
|
Mean ranking of incidental findings attribute
Time Frame: Day 1
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Stephen Clark, MD, University of North Carolina, Chapel Hill
- Study Director: Daniel Jonas, MD, MPH, University of North Carolina, Chapel Hill
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-2709
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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