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

• Study Type: Interventional
• Enrollment (Actual): 419
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina at Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

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.	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.
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.	Behavioral: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: UNC Cecil G. Sheps Center for Health Services Research
• 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

General Publications

• Clark SD, Reuland DS, Brenner AT, Jonas DE. Effect of Incidental Findings Information on Lung Cancer Screening Intent: a Randomized Controlled Trial. J Gen Intern Med. 2022 Nov;37(14):3676-3683. doi: 10.1007/s11606-022-07409-4. Epub 2022 Feb 2.

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2020
• Primary Completion (Actual): August 22, 2020
• Study Completion (Actual): August 22, 2020

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 8, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Incidental Findings
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 19-2709

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No