NCT01779726

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
331

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

December 3, 2014

Status Verified

August 1, 2013

Enrollment Period

1.6 years

First QC Date

January 28, 2013

Last Update Submit

December 2, 2014

Conditions

Keywords

Organizationof fast track

Outcome Measures

Primary Outcomes (1)

  • Chest physician time

    Time (in minutes) spent by a chest physician pr patient

    2013

Secondary Outcomes (1)

  • Satisfaction with new organisation

    2013

Study Arms (2)

CT scan before chest physician

EXPERIMENTAL

CT scan before chest physician

Radiation: CT scan before chest physician

Usual diagnostic workup

ACTIVE COMPARATOR

Usual diagnostic workup

Radiation: Usual diagnostic workup

Interventions

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

CT scan before chest physician

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)

Usual diagnostic workup

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Not referred from general practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus University

Aarhus, Aarhus, 8000, Denmark

Location

Department of lung medicine, Aarhus University Hospital

Aarhus, Aarhus, 8000, Denmark

Location

Related Publications (1)

  • Guldbrandt LM, Fenger-Gron M, Folkersen BH, Rasmussen TR, Vedsted P. Reduced specialist time with direct computed tomography for suspected lung cancer in primary care. Dan Med J. 2013 Dec;60(12):A4738.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Peter Vedsted, M.D., Prof.

    The Research Unit for General Practice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2013

First Posted

January 30, 2013

Study Start

January 1, 2012

Primary Completion

August 1, 2013

Study Completion

January 1, 2014

Last Updated

December 3, 2014

Record last verified: 2013-08

Locations