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

NCT ID: NCT02542332

Last Updated: 2015-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

556 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

With Data

Participants received statistical data about lung cancer screening

Group Type ACTIVE_COMPARATOR

With Data

Intervention Type OTHER

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

Without Data

Participants had no statistical data on lung cancer screening

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

With Data

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Otto Wagner Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Georg-Christian Funk

Priv. Doz. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Georg-Christian Funk, Assoc.Prof.

Role: PRINCIPAL_INVESTIGATOR

Otto Wagner Hospital

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 23136229 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2161310 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19671770 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25489865 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9609869 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25282284 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22710038 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22710039 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12038920 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25433982 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25734672 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25679109 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20719463 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22393129 (View on PubMed)

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.

Reference Type RESULT
PMID: 21714641 (View on PubMed)

Schmidt R, Breyer M, Breyer-Kohansal R, Urban M, Funk GC. Do doctors understand the test characteristics of lung cancer screening? Wien Klin Wochenschr. 2018 Apr;130(7-8):238-246. doi: 10.1007/s00508-017-1305-9. Epub 2018 Jan 25.

Reference Type DERIVED
PMID: 29372409 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Lung Cancer screening

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Lung Screening Study
NCT00006382 COMPLETED NA
Early Detection of Lung Cancer
NCT03181256 ACTIVE_NOT_RECRUITING