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

September 4, 2015 updated by: Georg-Christian Funk, Otto Wagner Hospital
This study evaluates whether doctors are familiar with the statistical background of lung cancer screening.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

556

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: With Data
Participants received statistical data about lung cancer screening
Other: With Data
The participants received statistical data about lung cancer screening in order to help them answer the questionaire
No Intervention: Without Data
Participants had no statistical data on lung cancer screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Between-groups difference in the estimated reduction of mortality due to lung cancer screening
Time Frame: 14 days
Participants had 14 days to complete the survey
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Between-groups difference prevalence of lung cancer
Time Frame: 14 days
Participants had 14 days to complete the survey
14 days
Between-groups difference in sensitivity of lung cancer screening
Time Frame: 14 days
Participants had 14 days to complete the survey
14 days
Between-groups difference in the frequency of a positive test result
Time Frame: 14 days
Participants had 14 days to complete the survey
14 days
Between-groups difference in specificity of lung cancer screening
Time Frame: 14 days
Participants had 14 days to complete the survey
14 days
Between-groups difference in positive predictive value of lung cancer screening
Time Frame: 14 days
Participants had 14 days to complete the survey
14 days
Between-groups difference in the false negative rate of lung cancer screening
Time Frame: 14 days
Participants had 14 days to complete the survey
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otto Wagner Hospital

Investigators

  • Principal Investigator: Georg-Christian Funk, Assoc.Prof., Otto Wagner Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

August 16, 2015

First Submitted That Met QC Criteria

September 4, 2015

First Posted (Estimate)

September 7, 2015

Study Record Updates

Last Update Posted (Estimate)

September 7, 2015

Last Update Submitted That Met QC Criteria

September 4, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lung Cancer screening

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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