Effect of Incidental Findings Information on Lung Cancer Screening Intent

NCT04432753 | Completed

• 1 other identifier: 19-2709
• Study Type: interventional
• Target: 419
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasm of Lung; Decision Support Techniques; Mass Screening

Keywords

Incidental Findings

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Mean score on scale of lung cancer screening knowledge

  Day 1

• Mean rating of benefit and harms of screening

  Day 1

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

  Day 1

• Mean ranking of benefit and harms of screening

  Day 1

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

  Day 1

Study Arms (2)

Decision aid with incidental findings information

EXPERIMENTAL

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

Decision aid without incidental findings information

ACTIVE COMPARATOR

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

Interventions

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.

Decision aid with incidental findings information

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.

Decision aid without incidental findings information

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year old male or female
• Current or former smoker who quit within the last 15 years
• At least 30 pack years of smoking

You may not qualify if:

• N/A

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• UNC Cecil G. Sheps Center for Health Services Research: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (1)

• 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.

  PMID: 35113322 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Stephen Clark, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Daniel Jonas, MD, MPH

  University of North Carolina, Chapel Hill

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 16, 2020
• Study Start: July 16, 2020
• Primary Completion: August 22, 2020
• Study Completion: August 22, 2020
• Last Updated: December 10, 2020

Record last verified: 2020-12

Locations

US (1)