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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date December 2020
Source UNC Lineberger Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


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
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