Study protocol

Should the surgeon or the general practitioner (GP) follow up patients after surgery for colon cancer? A randomized controlled trial protocol focusing on quality of life, cost-effectiveness and serious clinical events

Knut M Augestad^{* 1,2} , Barthold Vonen^2,3 , Ranveig Aspevik⁴ , Torunn Nestvold⁵ , Unni Ringberg⁶ , Roar Johnsen⁸ , Jan Norum^3,7 and Rolv-Ole Lindsetmo^{* 2,3,9}

¹Norwegian Centre for Telemedicine, Norway

²Department of Gastrointestinal Surgery, University Hospital of North Norway, Norway

³Institute of Clinical Medicine, Tromsø University, Norway

⁴Department of Surgery. Helgeland Hospital Trust, Mo i Rana, Norway

⁵Department of Surgery. Nordland Hospital Trust, Bodø, Norway

⁶Institute of Community Medicine, University Hospital of North Norway, Norway

⁷Northern Norway Regional Health Authority, Bodø, Norway

⁸Institute of Public Health and General Practice, Norwegian University of Science and Technology, Trondheim, Norway

⁹University Hospitals, Case Medical Centre, Cleveland, Ohio, USA

author email corresponding author email* Contributed equally

BMC Health Services Research 2008, 8:137doi:10.1186/1472-6963-8-137

Published:	25 June 2008

Abstract

Background

All patients who undergo surgery for colon cancer are followed up according to the guidelines of the Norwegian Gastrointestinal Cancer Group (NGICG). These guidelines state that the aims of follow-up after surgery are to perform quality assessment, provide support and improve survival. In Norway, most of these patients are followed up in a hospital setting. We describe a multi-centre randomized controlled trial to test whether these patients can be followed up by their general practitioner (GP) without altering quality of life, cost effectiveness and/or the incidence of serious clinical events.

Methods and Design

Patients undergoing surgery for colon cancer with histological grade Dukes's Stage A, B or C and below 75 years of age are eligible for inclusion. They will be randomized after surgery to follow-up at the surgical outpatient clinic (control group) or follow-up by the district GP (intervention group). Both study arms comply with the national NGICG guidelines. The primary endpoints will be quality of life (QoL) (measured by the EORTC QLQ C-30 and the EQ-5D instruments), serious clinical events (SCEs), and costs. The follow-up period will be two years after surgery, and quality of life will be measured every three months. SCEs and costs will be estimated prospectively. The sample size was 170 patients.

Discussion

There is an ongoing debate on the best method of follow-up for patients with CRC. Due to a wide range of follow-up programmes and paucity of randomized trials, it is impossible to draw conclusions about the best combination and frequency of clinic (or family practice) visits, blood tests, endoscopic procedures and radiological examinations that maximize the clinical outcome, quality of life and costs. Most studies on follow-up of CRC patients have been performed in a hospital outpatient setting. We hypothesize that postoperative follow-up of colon cancer patients (according to national guidelines) by GPs will not have any impact on patients' quality of life. Furthermore, we hypothesize that there will be no increase in SCEs and that the incremental cost-effectiveness ratio will improve.

Trial registration

This trial has been registered at ClinicalTrials.gov. The trial registration number is: NCT00572143