- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04819477
Can Austrian Lung Specialists' Assessments of Lung Cancer Screening be Influenced by a Fact Box?"
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Vienna, Austria, 1160
- Karl Landsteiner Institut für Lungenforschung und Pneumologische Onkologie
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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.
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
|
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
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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CT-Screening
Time Frame: through study completion, an average of 1 year
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Proportion of physicians CT-Screening
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through study completion, an average of 1 year
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Collaborators and Investigators
Investigators
- Principal Investigator: Georg-Christian Funk, MD, 2nd Medical Department with Pneumology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Version 5.0. / 14.10.2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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