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
Permanent link
https://hdl.handle.net/10037/2145Date
2008-06-25Type
Journal articleTidsskriftartikkel
Author
Vonen, Barthold; Augestad, Knut Magne; Aspevik, Ranveig; Norum, Jan; Nestvold, Torunn; Lindsetmo, Rolv-Ole; Ringberg, Unni; Johnsen, RoarAbstract
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 followup 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
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 followup 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
Description
This article is part of Knut Magne Augestad's PhD thesis, which is available in Munin at http://hdl.handle.net/10037/5167
Publisher
BioMed CentralCitation
BMC Health Services Research 2008, 8:137Metadata
Show full item recordCollections
The following license file are associated with this item: