Effect of Incidental Findings Information on Lung Cancer Screening Intent

NCT ID: NCT04432753

Last Updated: 2020-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

419 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-16

Study Completion Date

2020-08-22

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasm of Lung Decision Support Techniques Mass Screening

Keywords

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Incidental Findings

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Decision aid with incidental findings information

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

Group Type EXPERIMENTAL

Lung Cancer Screening Decision Aid with Incidental Findings Information

Intervention Type 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 without incidental findings information

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

Group Type ACTIVE_COMPARATOR

Lung Cancer Screening Decision Aid without Incidental Findings Information

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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UNC Cecil G. Sheps Center for Health Services Research

UNKNOWN

Sponsor Role collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephen Clark, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Daniel Jonas, MD, MPH

Role: STUDY_DIRECTOR

University of North Carolina, Chapel Hill

Locations

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University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35113322 (View on PubMed)

Other Identifiers

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19-2709

Identifier Type: -

Identifier Source: org_study_id