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Effect of Incidental Findings Information on Lung Cancer Screening Intent

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04432753
Enrollment
419
Registered
2020-06-16
Start date
2020-07-16
Completion date
2020-08-22
Last updated
2020-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decision Support Techniques, Mass Screening, Neoplasm of Lung

Keywords

Incidental Findings

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.

Interventions

BEHAVIORALLung 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.

BEHAVIORALLung 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.

Sponsors

UNC Cecil G. Sheps Center for Health Services Research
CollaboratorUNKNOWN
UNC Lineberger Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of individuals who plan to pursue lung cancer screeningDay 1This 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

MeasureTime frameDescription
Mean rating of benefit and harms of screeningDay 1Participants 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 lastDay 1Participants will rank six lung cancer screening benefits and harms.
Mean score on scale of lung cancer screening knowledgeDay 1Lung 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 harmsDay 1Participants will rank six lung cancer screening benefits and harms.
Mean ranking of incidental findings attributeDay 1Participants 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.
Mean ranking of benefit and harms of screeningDay 1Participants will rank six lung cancer screening benefits and harms.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026