This trial is active, not recruiting.

Condition colon cancer
Treatment ca coli follow-up by gp
Sponsor University Hospital of North Norway
Start date June 2007
End date December 2012
Trial size 180 participants
Trial identifier NCT00572143, P-REK NORD 79/2006


The purpose of this study is to clarify cost effectiveness and quality of life issues among colon cancer patients followed up in a hospital setting or by their GP`s.Statement of study hypothesis:Postoperative follow up of colon cancer patients (according to national guidelines) by general practitioners will not have any influence on patients' quality of life. There will not be observed any increase in serious clinical events and cost effectiveness will be improved.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
(Active Comparator)
Postoperative follow-up of ca coli patients at the surgical outpatient dpt
ca coli follow-up by gp
patients randomized to follow up by GP
(Active Comparator)
Postoperative follow-up of ca coli patients by GP`s
ca coli follow-up by gp
patients randomized to follow up by GP

Primary Outcomes

Quality of life; EORTC-QLQ-C30 and EQ 5D
time frame: 2 years

Secondary Outcomes

Cost-effectiveness Serious clinical events
time frame: 2 years

Eligibility Criteria

Male or female participants from 20 years up to 75 years old.

Inclusion Criteria: - Surgery for colon cancer (including rectosigmoid) with histological grade Duke stages A, B or C. - Completion of postsurgical chemotherapy (Dukes stage C patients). - Informed consent. Exclusion Criteria: - Patients with rectal cancer defined as cancer within 15 cm from anus. - A poor health status or operative complications making it natural to perform follow up by specialists. - Additional cancer diagnoses. - Disseminated cancer. - Poor mental status.

Additional Information

Official title Should the Surgeon or the General Practitioner (GP) Follow up Patients After Surgery for Colon Cancer? A Randomized Controlled Trial Focusing on Quality of Life, Cost-effectiveness and Serious Clinical Events.
Principal investigator Caroline Sagatun, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by University Hospital of North Norway.