Lung CancerNCT04819477
Can Austrian Lung Specialists' Assessments of Lung Cancer Screening be Influenced by a Fact Box?"
A study testing Fact box and Cates plot in people with Lung Cancer, run by Karl Landsteiner Institute for Lung Research and Pneumological Oncology at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Fact box and Cates plot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 973 participants
- Where
- 1 siteAustria
- Study dates
- 1 May 2021to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Non members of the Austrian Society of Pneumology (ÖGP)
Trial locations and contacts
1 site in 1 country.
Austria1 site
Karl Landsteiner Institut für Lungenforschung und Pneumologische Onkologie
Vienna, 1160
About this study
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Fact box, Cates plot
- Keywords
- Screening
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fact boxBehavioural
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.
Cates plotBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cate Plots | Other | 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. Receives: Behavioral: Fact box; Behavioral: Cates plot |
| Fact box only | Other | 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 Receives: Behavioral: Fact box |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT-Screening
Proportion of physicians CT-Screening
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 May 2021
- Primary completion30 Oct 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 973 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karl Landsteiner Institute for Lung Research and Pneumological Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georg-Christian Funk, MD, Principal investigator, 2nd Medical Department with Pneumology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819477
- Sponsor's protocol ID
- Version 5.0. / 14.10.2020
- Status last verified
- Mar 2024
- First submitted
- 24 Mar 2021
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Austrian Lung Specialists' Assessments of Lung Cancer Screening be Influenced by a Fact Box?"
- ClinicalTrials.gov ID
- NCT04819477
- Acronym / sponsor ID
- Version 5.0. / 14.10.2020
- Conditions
- Lung Cancer
- Keywords
- Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 973 participants (actual)
- Lead sponsor
- Karl Landsteiner Institute for Lung Research and Pneumological OncologyUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cate Plots | Other | Behavioral: Fact box, Behavioral: Cates plotafter 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. |
| Fact box only | Other | Behavioral: Fact boxafter 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Non members of the Austrian Society of Pneumology (ÖGP)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fact boxAll 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. | Behavioural | Cate Plots, Fact box only |
| Cates plotIn 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. | Behavioural | Cate Plots |
Primary outcome
CT-Screening
Time frame: through study completion, an average of 1 year
Proportion of physicians CT-Screening
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georg-Christian Funk, MD principal investigator
2nd Medical Department with Pneumology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fact box and Cates plot in people with Lung Cancer, run by Karl Landsteiner Institute for Lung Research and Pneumological Oncology at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT-Screening (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.