Efficiency of Diagnostic Strategy for Fast Track Lung Cancer Diagnosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01779726
Recruitment Status : Completed
First Posted : January 30, 2013
Last Update Posted : December 3, 2014
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

Annually, 4,200 new cases of lung cancer are diagnosed in Denmark. The stage of the disease is an important prognostic factor as an advanced stage reduces the opportunity for surgical intervention and other curative treatment. In denmark, as in many other countries, a fast track evaluation for lung cancer has been introduced in 2008.

When the general practitioners refer patients through the fast track, the majority of patients make their first visit to the Department of Pulmonary Medicine. After this visit, further investigation is initiated, which is often a CT scan of the chest and the upper abdomen. We dont know Whether this is the most appropriate organisation.

The aim of this project is to evaluate the way lung cancer patients are examined through the fast track and the impact of chest CT before an evaluation by a chest physician.

Investigators want to randomise all patients referred for the existing fast track to either direct CT scan of chest and upper abdomen or to evaluation by the chest physician, in order to test:

A) Fast track performance measured by number of CT scans and chest physician specialist time per diagnosis, and whether there is a difference between the intervention and the control group.

Condition or disease Intervention/treatment Phase
Lung Cancer Radiation: CT scan before chest physician Radiation: Usual diagnostic workup Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 331 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Efficiency of Diagnostic Strategy for Fast Track Lung Cancer Diagnosis. A Randomised Controlled Trial.
Study Start Date : January 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: CT scan before chest physician
CT scan before chest physician
Radiation: CT scan before chest physician
Patients referred to department of lung medicine are randomised according to the month of birth. Patients born in even months are CT scan before a consultation with a chest physician
Active Comparator: Usual diagnostic workup
Usual diagnostic workup
Radiation: Usual diagnostic workup
Patients born in odd months seen in the department of lung medicine by a chest physician and maybe then CT scanned (usual workup practice according to the fast track evaluation)

Primary Outcome Measures :
  1. Chest physician time [ Time Frame: 2013 ]
    Time (in minutes) spent by a chest physician pr patient

Secondary Outcome Measures :
  1. Satisfaction with new organisation [ Time Frame: 2013 ]
    Measured with a qualitative focus interview with staff a the Department of lung medicine (doctors, nurses and secretary).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients referred to fast track evaluation (lung department, Aarhus university hospital) from primary care.

Exclusion Criteria:

  • Not referred from general practice

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01779726

Aarhus University
Aarhus, Denmark, 8000
Department of lung medicine, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Principal Investigator: Peter Vedsted, M.D., Prof. The research unit for general practice

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Aarhus Identifier: NCT01779726     History of Changes
Other Study ID Numbers: 118/2011
First Posted: January 30, 2013    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: August 2013

Keywords provided by University of Aarhus:
of fast track

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases