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Effect of Incidental Findings Information on Lung Cancer Screening Intent

Primary Purpose

Neoplasm of Lung, Decision Support Techniques, Mass Screening

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lung Cancer Screening Decision Aid with Incidental Findings Information
Lung Cancer Screening Decision Aid without Incidental Findings Information
Sponsored by
UNC Lineberger Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Neoplasm of Lung focused on measuring Incidental Findings

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Decision aid with incidental findings information

Decision aid without incidental findings information

Arm Description

Participants in this arm will view a video decision aid that include information on incidental findings in lung cancer screening.

Participants in this arm will view a video decision aid that does not include information on incidental findings in lung cancer screening.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Percentage of Time Lung Cancer Screening Benefit and Harms are ranked first and last
Participants will rank six lung cancer screening benefits and harms.
Mean ranking of benefit and harms of screening
Participants will rank six lung cancer screening benefits and harms.
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.
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.

Full Information

First Posted
May 28, 2020
Last Updated
December 8, 2020
Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
UNC Cecil G. Sheps Center for Health Services Research
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1. Study Identification

Unique Protocol Identification Number
NCT04432753
Brief Title
Effect of Incidental Findings Information on Lung Cancer Screening Intent
Official Title
Effect of Incidental Findings Information on Lung Cancer Screening Intent: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 16, 2020 (Actual)
Primary Completion Date
August 22, 2020 (Actual)
Study Completion Date
August 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
UNC Cecil G. Sheps Center for Health Services Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm of Lung, Decision Support Techniques, Mass Screening
Keywords
Incidental Findings

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
419 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Decision aid with incidental findings information
Arm Type
Experimental
Arm Description
Participants in this arm will view a video decision aid that include information on incidental findings in lung cancer screening.
Arm Title
Decision aid without incidental findings information
Arm Type
Active Comparator
Arm Description
Participants in this arm will view a video decision aid that does not include information on incidental findings in lung cancer screening.
Intervention Type
Behavioral
Intervention Name(s)
Lung Cancer Screening Decision Aid with Incidental Findings Information
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lung Cancer Screening Decision Aid without Incidental Findings Information
Intervention Description
The intervention consists of a previously tested and developed brief lung cancer screening video decision aid that does not include information on incidental findings.
Primary Outcome Measure Information:
Title
Percentage of individuals who plan to pursue lung cancer screening
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Mean score on scale of lung cancer screening knowledge
Description
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.
Time Frame
Day 1
Title
Mean rating of benefit and harms of screening
Description
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.
Time Frame
Day 1
Title
Percentage of Time Lung Cancer Screening Benefit and Harms are ranked first and last
Description
Participants will rank six lung cancer screening benefits and harms.
Time Frame
Day 1
Title
Mean ranking of benefit and harms of screening
Description
Participants will rank six lung cancer screening benefits and harms.
Time Frame
Day 1
Title
Percentage of time each lung cancer screening harm is ranked highest of the five potential harms
Description
Participants will rank six lung cancer screening benefits and harms.
Time Frame
Day 1
Title
Mean ranking of incidental findings attribute
Description
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.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Clark, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Jonas, MD, MPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Study Director
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35113322
Citation
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.
Results Reference
derived

Learn more about this trial

Effect of Incidental Findings Information on Lung Cancer Screening Intent

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