Mass Screening Clinical Trial
Official title:
Effect of Incidental Findings Information on Lung Cancer Screening Intent: A Randomized Controlled Trial
NCT number | NCT04432753 |
Other study ID # | 19-2709 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 16, 2020 |
Est. completion date | August 22, 2020 |
Verified date | December 2020 |
Source | UNC Lineberger Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 419 |
Est. completion date | August 22, 2020 |
Est. primary completion date | August 22, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 55 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
UNC Lineberger Comprehensive Cancer Center | UNC Cecil G. Sheps Center for Health Services Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Mean ranking of benefit and harms of screening | Participants will rank six lung cancer screening benefits and harms. | Day 1 | |
Secondary | 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 | |
Secondary | 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 |
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