Effect of Incidental Findings Information on Lung Cancer Screening Intent

Not Applicable

Completed

• Conditions: Decision Support Techniques; Neoplasm of Lung; Mass Screening
• Interventions: Behavioral: Lung Cancer Screening Decision Aid without Incidental Findings Information; Behavioral: Lung Cancer Screening Decision Aid with Incidental Findings Information

• Registration Number: NCT04432753
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-28
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-16
• Study Start: 2020-07-16
• Primary Completion: 2020-08-22
• Study Completion: 2020-08-22
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-08
• Last Update Posted: 2020-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 419

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Decision aid without incidental findings information	Lung Cancer Screening 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.
Decision aid with incidental findings information	Lung Cancer Screening 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.

Primary Outcome Measures

Name	Time	Method
Percentage of individuals who plan to pursue lung cancer screening	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.

Secondary Outcome Measures

Name	Time	Method
Mean ranking of benefit and harms of screening	Day 1	Participants will rank six lung cancer screening benefits and harms.
Mean rating of benefit and harms of screening	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.
Mean score on scale of lung cancer screening knowledge	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.
Percentage of time each lung cancer screening harm is ranked highest of the five potential harms	Day 1	Participants will rank six lung cancer screening benefits and harms.
Mean ranking of incidental findings attribute	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.
Percentage of Time Lung Cancer Screening Benefit and Harms are ranked first and last	Day 1	Participants will rank six lung cancer screening benefits and harms.

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States