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

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Fact box
Cates plot
Sponsored by
Karl Landsteiner Institute for Lung Research and Pneumological Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Cancer focused on measuring Screening

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Karl Landsteiner Institut für Lungenforschung und Pneumologische OnkologieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Cate Plots

Fact box only

Arm Description

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.

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

Outcomes

Primary Outcome Measures

CT-Screening
Proportion of physicians CT-Screening

Secondary Outcome Measures

Full Information

First Posted
March 24, 2021
Last Updated
August 18, 2022
Sponsor
Karl Landsteiner Institute for Lung Research and Pneumological Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT04819477
Brief Title
Can Austrian Lung Specialists' Assessments of Lung Cancer Screening be Influenced by a Fact Box?"
Official Title
Can Austrian Lung Specialists' Assessments of Lung Cancer Screening be Influenced by a Fact Box?"
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Karl Landsteiner Institute for Lung Research and Pneumological Oncology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cate Plots
Arm Type
Other
Arm Description
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.
Arm Title
Fact box only
Arm Type
Other
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Fact box
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cates plot
Intervention Description
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.
Primary Outcome Measure Information:
Title
CT-Screening
Description
Proportion of physicians CT-Screening
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georg-Christian Funk, MD
Phone
+43 1 49150
Ext
2203
Email
georg-christian.funk@gesundheitsverbund.at
First Name & Middle Initial & Last Name or Official Title & Degree
Carolina Nell, Dr.
Phone
+41 1 49150
Email
carolina.nell@gesundheitsverbund.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg-Christian Funk, MD
Organizational Affiliation
2nd Medical Department with Pneumology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karl Landsteiner Institut für Lungenforschung und Pneumologische Onkologie
City
Vienna
ZIP/Postal Code
1160
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georg-Christian Funk, MD
Phone
+41 1 49150
Ext
2203
Email
georg-christian.funk@gesundheitsverbund.at
First Name & Middle Initial & Last Name & Degree
Agnes Attoh, BSc
Phone
+41 1 49150
Ext
72203
Email
agnes.attoh@extern.gesundheitsverbund.at

12. IPD Sharing Statement

Plan to Share IPD
No

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

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