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OpenTrials
Completed

NCT Number: NCT04432753

Effect of Incidental Findings Information on Lung Cancer Screening Intent

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.

Completed

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Key information

Conditions

Neoplasm of Lung Decision Support Techniques Lung Diseases Lung Neoplasms Mass Screening Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lung Cancer Screening Decision Aid with Incidental Findings Information

Behavioral

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

Behavioral

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 outcomes

  1. Percentage of individuals who plan to pursue lung cancer screening

    Time frame: Day 1

    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 outcomes

  1. Mean score on scale of lung cancer screening knowledge

    Time frame: Day 1

    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.

  2. Mean rating of benefit and harms of screening

    Time frame: Day 1

    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.

  3. Percentage of Time Lung Cancer Screening Benefit and Harms are ranked first and last

    Time frame: Day 1

    Participants will rank six lung cancer screening benefits and harms.

  4. Mean ranking of benefit and harms of screening

    Time frame: Day 1

    Participants will rank six lung cancer screening benefits and harms.

  5. Percentage of time each lung cancer screening harm is ranked highest of the five potential harms

    Time frame: Day 1

    Participants will rank six lung cancer screening benefits and harms.

  6. Mean ranking of incidental findings attribute

    Time frame: Day 1

    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.

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • UNC Cecil G. Sheps Center for Health Services Research

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 16, 2020
Registry last updated
Dec 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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