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Information About the Knowledge on the Statistical Background of Lung Cancer Screening of DoctorsNCT02542332

Are Doctors Familiar With the Test Characteristics of Lung Cancer Screening?

A study testing With Data in people with Information About the Knowledge on the Statistical Background of Lung Cancer Screening of Doctors, run by Otto Wagner Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates whether doctors are familiar with the statistical background of lung cancer screening. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
With Data
Could I receive a placebo?
No, everyone receives an active treatment
How many people
556 participants
Where
No sites listed yet
Study dates
May 2015to Aug 2015
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Doctors, who were in training or had a completed specialization training in:
  • Pneumonology
  • Internal Medicine
  • Surgery
  • or Radiology

Who cannot join

  • Doctors, with a specialized training in
  • ENT
  • Pediatrics
  • Pathology and doctors who had no e-mail address were excluded.

About this study

This study evaluates whether doctors are familiar with the statistical background of lung cancer screening.

Read the detailed description

Background: Screening with low-dose CT scan can prevent three deaths due to lung cancer among 1000 high-risk individuals. However, false-positive results and radiation exposure are relevant disadvantages deserving accurate consideration. Candidates for screening can only make an autonomous decision if doctors inform them correctly about the pros and cons of the method. Therefore, this study aims to evaluate, whether doctors understand the test characteristics of lung cancer screening.

Methods: In a randomized trial, 556 doctors (members of the Austrian Respiratory Society) will be invited to answer questions regarding lung cancer screening based on online case vignettes. Half of the participants will be randomized to the group 'with data' and will receive the correct solutions in advance. The group 'without data' will have to rely on prior knowledge or estimate. Primary endpoint will be the between-groups difference in the estimated number of deaths preventable by screening. Secondary endpoints will be the between-groups differences in prevalence of lung cancer, prevalence of suspicious results, sensitivity, specificity, positive-predictive value, and false negative rate. Estimations will also be compared to actual values from the literature.

Being tested
With Data
Keywords
lung cancer screening, statistical background

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • With DataOther

    The participants received statistical data about lung cancer screening in order to help them answer the questionaire

Study groups in NCT02542332
Study groupRoleWhat they receive
With DataActive comparatorParticipants received statistical data about lung cancer screening
Receives: Other: With Data
Without DataNo interventionParticipants had no statistical data on lung cancer screening

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Between-groups difference in the estimated reduction of mortality due to lung cancer screening

    Participants had 14 days to complete the survey

    Measured: 14 days

Secondary outcomes (6)

  1. Between-groups difference prevalence of lung cancer

    Participants had 14 days to complete the survey

    Measured: 14 days

  2. Between-groups difference in sensitivity of lung cancer screening

    Participants had 14 days to complete the survey

    Measured: 14 days

  3. Between-groups difference in the frequency of a positive test result

    Participants had 14 days to complete the survey

    Measured: 14 days

  4. Between-groups difference in specificity of lung cancer screening

    Participants had 14 days to complete the survey

    Measured: 14 days

  5. Between-groups difference in positive predictive value of lung cancer screening

    Participants had 14 days to complete the survey

    Measured: 14 days

  6. Between-groups difference in the false negative rate of lung cancer screening

    Participants had 14 days to complete the survey

    Measured: 14 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
556 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02542332
Sponsor's protocol ID
Lung Cancer screening
Status last verified
Aug 2015
First submitted
16 Aug 2015
Last updated
7 Sep 2015
Results posted
No
Data monitoring committee
No

Publications

  • Couraud S, Cortot AB, Greillier L, Gounant V, Mennecier B, Girard N, Besse B, Brouchet L, Castelnau O, Frappe P, Ferretti GR, Guittet L, Khalil A, Lefebure P, Laurent F, Liebart S, Molinier O, Quoix E, Revel MP, Stach B, Souquet PJ, Thomas P, Tredaniel J, Lemarie E, Zalcman G, Barlesi F, Milleron B; French lung cancer screening statement taskforce; groupe d'Oncologie de langue francaise. From randomized trials to the clinic: is it time to implement individual lung-cancer screening in clinical practice? A multidisciplinary statement from French experts on behalf of the French intergroup (IFCT) and the groupe d'Oncologie de langue francaise (GOLF). Ann Oncol. 2013 Mar;24(3):586-97. doi: 10.1093/annonc/mds476. Epub 2012 Nov 7.

    PubMed 23136229

  • Dupont WD, Plummer WD Jr. Power and sample size calculations. A review and computer program. Control Clin Trials. 1990 Apr;11(2):116-28. doi: 10.1016/0197-2456(90)90005-m.

    PubMed 2161310

  • Gigerenzer G, Mata J, Frank R. Public knowledge of benefits of breast and prostate cancer screening in Europe. J Natl Cancer Inst. 2009 Sep 2;101(17):1216-20. doi: 10.1093/jnci/djp237. Epub 2009 Aug 11.

    PubMed 19671770

  • Herth FJ, Hoffmann H, Heussel CP, Biederer J, Groschel A. [Lung cancer screening--update 2014]. Pneumologie. 2014 Dec;68(12):781-3. doi: 10.1055/s-0034-1390899. Epub 2014 Dec 9. No abstract available. German.

    PubMed 25489865

  • Hoffrage U, Gigerenzer G. Using natural frequencies to improve diagnostic inferences. Acad Med. 1998 May;73(5):538-40. doi: 10.1097/00001888-199805000-00024.

    PubMed 9609869

  • Horeweg N, Scholten ET, de Jong PA, van der Aalst CM, Weenink C, Lammers JW, Nackaerts K, Vliegenthart R, ten Haaf K, Yousaf-Khan UA, Heuvelmans MA, Thunnissen E, Oudkerk M, Mali W, de Koning HJ. Detection of lung cancer through low-dose CT screening (NELSON): a prespecified analysis of screening test performance and interval cancers. Lancet Oncol. 2014 Nov;15(12):1342-50. doi: 10.1016/S1470-2045(14)70387-0. Epub 2014 Oct 1.

    PubMed 25282284

  • Jacobson FL, Austin JH, Field JK, Jett JR, Keshavjee S, MacMahon H, Mulshine JL, Munden RF, Salgia R, Strauss GM, Sugarbaker DJ, Swanson SJ, Travis WD, Jaklitsch MT. Development of The American Association for Thoracic Surgery guidelines for low-dose computed tomography scans to screen for lung cancer in North America: recommendations of The American Association for Thoracic Surgery Task Force for Lung Cancer Screening and Surveillance. J Thorac Cardiovasc Surg. 2012 Jul;144(1):25-32. doi: 10.1016/j.jtcvs.2012.05.059.

    PubMed 22710038

  • Jaklitsch MT, Jacobson FL, Austin JH, Field JK, Jett JR, Keshavjee S, MacMahon H, Mulshine JL, Munden RF, Salgia R, Strauss GM, Swanson SJ, Travis WD, Sugarbaker DJ. The American Association for Thoracic Surgery guidelines for lung cancer screening using low-dose computed tomography scans for lung cancer survivors and other high-risk groups. J Thorac Cardiovasc Surg. 2012 Jul;144(1):33-8. doi: 10.1016/j.jtcvs.2012.05.060.

    PubMed 22710039

  • Nuovo J, Melnikow J, Chang D. Reporting number needed to treat and absolute risk reduction in randomized controlled trials. JAMA. 2002 Jun 5;287(21):2813-4. doi: 10.1001/jama.287.21.2813.

    PubMed 12038920

  • Rasmussen JF, Siersma V, Pedersen JH, Brodersen J. Psychosocial consequences in the Danish randomised controlled lung cancer screening trial (DLCST). Lung Cancer. 2015 Jan;87(1):65-72. doi: 10.1016/j.lungcan.2014.11.003. Epub 2014 Nov 20.

    PubMed 25433982

  • Schulz C. [Lung cancer screening and management of small pulmonary nodules]. Dtsch Med Wochenschr. 2015 Mar;140(5):317-22. doi: 10.1055/s-0041-100760. Epub 2015 Mar 3. German.

    PubMed 25734672

  • Simmons J, Gould MK, Woloshin S, Schwartz LM, Wiener RS. Attitudes about low-dose computed tomography screening for lung cancer: a survey of American Thoracic Society Clinicians. Am J Respir Crit Care Med. 2015 Feb 15;191(4):483-6. doi: 10.1164/rccm.201409-1747LE. No abstract available.

    PubMed 25679109

  • Wegwarth O, Gigerenzer G. "There is nothing to worry about": gynecologists' counseling on mammography. Patient Educ Couns. 2011 Aug;84(2):251-6. doi: 10.1016/j.pec.2010.07.025. Epub 2010 Aug 16.

    PubMed 20719463

  • Wegwarth O, Schwartz LM, Woloshin S, Gaissmaier W, Gigerenzer G. Do physicians understand cancer screening statistics? A national survey of primary care physicians in the United States. Ann Intern Med. 2012 Mar 6;156(5):340-9. doi: 10.7326/0003-4819-156-5-201203060-00005.

    PubMed 22393129

  • National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.

    PubMed 21714641

Questions about this trial

What is this clinical trial studying?

A study testing With Data in people with Information About the Knowledge on the Statistical Background of Lung Cancer Screening of Doctors, run by Otto Wagner Hospital.

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 5 inclusion and 4 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 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

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?

Between-groups difference in the estimated reduction of mortality due to lung cancer screening (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02542332, which also lists 16 linked publications.

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 7 Sep 2015.

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