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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
CT scan and education
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Lung Cancer focused on measuring Lung cancer, early detection, CT scan, General Practice, Effect of Computed Tomography scans, Clinical medical education

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • former lung cancer patients.

Sites / Locations

  • University of Aarhus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CT scan and education

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Delay
Time from first presentation i General Practice to the patient obtains the diagnosis

Secondary Outcome Measures

Referral pattern (use of fast-track packet)
Primary use of CT
1-year mortality.

Full Information

First Posted
January 20, 2012
Last Updated
August 5, 2013
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT01527214
Brief Title
The Effect of Direct Referral for Fast CT Scan in Early Lung Cancer Detection in General Practice
Official Title
The Effect of Direct Referral for Fast CT Scan in Early Lung Cancer Detection in General Practice. Clinical, Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung cancer, early detection, CT scan, General Practice, Effect of Computed Tomography scans, Clinical medical education

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
650 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT scan and education
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
CT scan and education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Delay
Description
Time from first presentation i General Practice to the patient obtains the diagnosis
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Referral pattern (use of fast-track packet)
Time Frame
12 month
Title
Primary use of CT
Time Frame
12 month
Title
1-year mortality.
Time Frame
24 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: all practices referring to the Department of Pulmonary Medicine, Aarhus University Hospital. Exclusion Criteria: former lung cancer patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Vedsted, Professor
Organizational Affiliation
The Research Unit for Generel Practice
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Aarhus
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26608727
Citation
Guldbrandt LM, Fenger-Gron M, Rasmussen TR, Rasmussen F, Meldgaard P, Vedsted P. The effect of direct access to CT scan in early lung cancer detection: an unblinded, cluster-randomised trial. BMC Cancer. 2015 Nov 25;15:934. doi: 10.1186/s12885-015-1941-2.
Results Reference
derived
PubMed Identifier
25383780
Citation
Guldbrandt LM, Rasmussen TR, Rasmussen F, Vedsted P. Implementing direct access to low-dose computed tomography in general practice--method, adaption and outcome. PLoS One. 2014 Nov 10;9(11):e112162. doi: 10.1371/journal.pone.0112162. eCollection 2014.
Results Reference
derived

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

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