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Efficiency of Diagnostic Strategy for Fast Track Lung Cancer Diagnosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01779726
First received: January 28, 2013
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

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 Intervention
Lung Cancer
Radiation: CT scan before chest physician
Radiation: Usual diagnostic workup

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Efficiency of Diagnostic Strategy for Fast Track Lung Cancer Diagnosis. A Randomised Controlled Trial.

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Chest physician time [ Time Frame: 2013 ] [ Designated as safety issue: No ]
    Time (in minutes) spent by a chest physician pr patient


Secondary Outcome Measures:
  • Satisfaction with new organisation [ Time Frame: 2013 ] [ Designated as safety issue: No ]
    Measured with a qualitative focus interview with staff a the Department of lung medicine (doctors, nurses and secretary).


Estimated Enrollment: 600
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not referred from general practice
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779726

Contacts
Contact: Louise M. Guldbrandt, M.D +45 87168037 louise.mahncke@alm.au.dk

Locations
Denmark
Aarhus University Completed
Aarhus, Denmark, 8000
Department of lung medicine, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Louise M. Guldbrandt, M.D    +45 87168037    louise.mahncke@alm.au.dk   
Principal Investigator: Louise M. Guldbrandt, M.D.         
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Peter Vedsted, M.D., Prof. The research unit for general practice
  More Information

No publications provided by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01779726     History of Changes
Other Study ID Numbers: 118/2011
Study First Received: January 28, 2013
Last Updated: August 5, 2013
Health Authority: Denmark: National Board of Health
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Organization
of fast track

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

ClinicalTrials.gov processed this record on November 20, 2014