Can Austrian Lung Specialists' Assessments of Lung Cancer Screening be Influenced by a Fact Box?"

March 15, 2024 updated by: Karl Landsteiner Institute for Lung Research and Pneumological Oncology
Lung cancer is the most frequently dianosed cancer worldwide. To date, no screening method has been able to establish itself as routinely recommended by the guidelines. In this prospective study with 1:1 randomized questioning using an Internet tool, physicians will be asked in 2 phases (before and after intervention with a fact box) about their assessment of the benefits and risks of lung cancer screening by thoracic computed tomography and about a potential intention to change referral behavior. Randomly assigned, half of the participants will receive the same information in addition to the fact box graphically presented as a Cates plot.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The topic of lung cancer screening is highly topical and relevant in that this cancer is the most frequently diagnosed worldwide and has the highest mortality among malignancies. To date, no screening method has been able to establish itself as routinely recommended by the guidelines. In the recently published Dutch-Belgian NELSON study on low dose thoracic CT as a screening method in high-risk patients (smokers and ex-smokers), an - albeit small - reduction in mortality was shown in the screening group vs. the control group).

A prerequisite for a detailed information of the patient about the implementation as well as the advantages and disadvantages of screening is that the physician has risk competence and knows and is able to interpret the screening data. The use of a fact box can be used to improve knowledge of statistical data.

In this prospective study with 1:1 randomized questioning using an Internet tool, physicians will be asked in 2 phases (before and after intervention with a fact box) about their assessment of the benefits and risks of lung cancer screening by thoracic computed tomography and about a potential intention to change referral behavior. Randomly assigned, half of the participants will receive the same information in addition to the fact box graphically presented as a Cates plot.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
973

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Austria
      • Vienna, Austria, 1160
        • Karl Landsteiner Institut für Lungenforschung und Pneumologische Onkologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Members of the Austrian Society of Pneumology (ÖGP) with a completed pulmonary subject and members of the Austrian Radiological Society (ÖRG), Society for Medical Radiology and Nuclear Medicine with a completed subject.

Exclusion Criteria:

  • Non members of the Austrian Society of Pneumology (ÖGP)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Cate Plots
after being asked about current referral practices and assessment of benefits and risks of lung cancer screening, all respondents will receive the Fact box after which they will be randomized into two equal groups. The first group (Arm 1) receives a Cates plot and then another survey about assessment of benefits and risks of lung cancer screening and potential change in referral behavior.
Behavioral: Fact box

All physicians surveyed receive a fact box with numerical information on the benefits and harms of chest CT as a screening method.

In addition to the fact box, half of the participants will be randomly assigned to receive the same information in the form of a Cates plot.

Behavioral: Cates plot
In addition to the fact box, half of the participants will be randomly assigned to receive the same information in the form of a Cates plot.
Other: Fact box only
after being asked about current referral practices and assessment of benefits and risks of lung cancer screening, all respondents will receive the Fact box after which they will be randomized into two equal groups. The second group (Arm 2) receives then a survey about assessment of benefits and risks of lung cancer screening and potential change in referral behavior
Behavioral: Fact box

All physicians surveyed receive a fact box with numerical information on the benefits and harms of chest CT as a screening method.

In addition to the fact box, half of the participants will be randomly assigned to receive the same information in the form of a Cates plot.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
CT-Screening
Time Frame: through study completion, an average of 1 year
Proportion of physicians CT-Screening
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karl Landsteiner Institute for Lung Research and Pneumological Oncology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Georg-Christian Funk, MD, 2nd Medical Department with Pneumology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Version 5.0. / 14.10.2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Drug Interventions

Dietary Supplements

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