Effect of Incidental Findings Information on Lung Cancer Screening Intent

Mass Screening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04432753
• Other study ID #: 19-2709
• Status: Completed
• Phase: N/A
• Start date: July 16, 2020
• Est. completion date: August 22, 2020

Study information

• Verified date: December 2020
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Decision Support Techniques
• Lung Neoplasms
• Mass Screening
• Neoplasm of Lung

Intervention

Behavioral:
• Lung Cancer Screening Decision Aid with Incidental Findings Information
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.
• Lung Cancer Screening Decision Aid without Incidental Findings Information
The intervention consists of a previously tested and developed brief lung cancer screening video decision aid that does not include information on incidental findings.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	UNC Cecil G. Sheps Center for Health Services Research

Country where clinical trial is conducted

United States, 

Outcome

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