The Effect of Direct Referral for Fast CT Scan in Early Lung Cancer Detection in General Practice

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01527214
First received: January 20, 2012
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

Background: The primary investigation of lung cancer (LC) is for 85% of the cases conducted through General Practice, sadly it tends to take a relatively long time from first time the patient is seen by their General Practitioner and until they are diagnosed. LC symptoms are common, but usual because of benign diseases. Only 33% of LC patients presenting with alarm symptoms. On average a General Practitioner in Denmark sees only one patient with newly diagnosed lung cancer a year and the doctor will therefore get the clinical experience that when they refer a patient, test often come out negative and they therefore fail to refer and delay will increase - with a poorer prognosis as a result. Centrally in the diagnosis is conventional chest X-ray, which unfortunately is inefficient in many cases, while CT scanning has proven effective even for small tumors.

Hypothesis and aims: The project has three main hypotheses to be tested 1) the GP's use of cancer fast-track and detection of suspected lung cancer can be optimized in relation to interpretation of symptoms and subsequent referral practices and radiological investigation. 2) General Practitioners with special training can change the referral routines and 3) direct access to fast CT scanning leads to earlier diagnosis of lung cancer.

Methods: The first part of the study is a register-based study of lung cancer patients' road to diagnosis, based on a database of newly diagnosed cancer patients in a year. Second part of the study is a clinical, randomized study of the effect of referral directly to fast chest CT scan. Primary endpoint is delay, secondary endpoints are referral pattern (use of fast-track packet), primary use of CT and 1-year mortality. Furthermore side effects, including patient groups with increased delay.

The study will contribute new knowledge to the way GP's interpret symptoms, the way they refer their patients when they suspect cancer, their use of diagnostic imaging and cancer fast-track pathways. It will then provide a unique opportunity to create the necessary knowledge about the effects of direct referral to fast CT scan and it might be a decision aid whether to open for direct CT scan in General Practice for a group of patients.


Condition Intervention
Lung Cancer
Radiation: CT scan and education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: The Effect of Direct Referral for Fast CT Scan in Early Lung Cancer Detection in General Practice. Clinical, Randomised Trial

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Delay [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Time from first presentation i General Practice to the patient obtains the diagnosis


Secondary Outcome Measures:
  • Referral pattern (use of fast-track packet) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Primary use of CT [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • 1-year mortality. [ Time Frame: 24 month ] [ Designated as safety issue: No ]

Enrollment: 650
Study Start Date: November 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CT scan and education
All general practices referring to the Department of Pulmonary Medicine, Aarhus University Hospital.Randomized 1:1. In the intervention group, GPs continue to refer to the lung cancer fast track when indicated. In addition, they are allowed to refer directly to a rapid chest CT scan in cases where they find reasons to examine the patient for lung diseases without having sufficient suspicion of lung cancer to refer the patient to the lung cancer fast track. The GPs will be offered special training related to the diagnosis of lung cancer in general practice before the new referral option is introduced. This will be done by offering training sessions and written material.
Radiation: CT scan and education
GPs get direct access to chest CT scans for their patients. The GPs will be offered special training related to the diagnosis of lung cancer in general practice.This will be done by offering training sessions and written material. The training will include risk groups, alarm symptoms, symptom complexes and interpretation of CT scan descriptions.
No Intervention: Control
Cluster eligibility: all practices referring to the Department of Pulmonary Medicine, Aarhus University Hospital. Randomized 1:1. Control arm continues with the usual referral pattern

  Eligibility

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

Inclusion Criteria:

  • all practices referring to the Department of Pulmonary Medicine, Aarhus University Hospital.

Exclusion Criteria:

  • former lung cancer patients.
  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: NCT01527214

Locations
Denmark
University of Aarhus
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Peter Vedsted, Professor The Research Unit for Generel Practice
  More Information

Additional Information:
No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01527214     History of Changes
Other Study ID Numbers: DirectCT
Study First Received: January 20, 2012
Last Updated: August 5, 2013
Health Authority: Denmark: Centre for Public Health
Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Lung cancer
early detection
CT scan
General Practice
Effect of Computed Tomography scans
Clinical medical education

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

ClinicalTrials.gov processed this record on July 24, 2014