Clinical trial NCT00572143: Follow-up After Surgery for Colon Cancer. General Practice vs. Surgical-based Follow-up?
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Keywords: Colonic Neoplasms/surgery*
Continuity of Patient Care*
Follow-Up Studies
Quality of Life
Patient Satisfaction
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2007-12-12
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life; EORTC-QLQ-C30 and EQ 5D
timeFrame: 2 years
Secondary outcomes:
measure: Cost-effectiveness Serious clinical events
timeFrame: 2 years
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: University of Tromso
name: Rolv-Ole Lindsetmo, MD, PHd
role: STUDY_CHAIR
affiliation: Bodø Hospital Trust
name: Caroline Sagatun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of North Norway (Harstad)
name: Niels Krum-Hansen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Augestad KM, Norum J, Rose J, Lindsetmo RO. A prospective analysis of false positive events in a National Colon Cancer Surveillance Program. BMC Health Serv Res. 2014 Mar 27;14:137. doi: 10.1186/1472-6963-14-137.
citation: Augestad KM, Norum J, Dehof S, Aspevik R, Ringberg U, Nestvold T, Vonen B, Skrovseth SO, Lindsetmo RO. Cost-effectiveness and quality of life in surgeon versus general practitioner-organised colon cancer surveillance: a randomised controlled trial. BMJ Open. 2013 Apr 4;3(4):e002391. doi: 10.1136/bmjopen-2012-002391. Print 2013.
citation: Augestad KM, Vonen B, Aspevik R, Nestvold T, Ringberg U, Johnsen R, Norum J, Lindsetmo RO. 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. BMC Health Serv Res. 2008 Jun 25;8:137. doi: 10.1186/1472-6963-8-137.