search
Back to results

Follow-up After Surgery for Colon Cancer. General Practice vs. Surgical-based Follow-up? (ONKOLINK)

Primary Purpose

Colon Cancer

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
ca coli follow-up by GP
Sponsored by
University Hospital of North Norway
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colon Cancer focused on measuring Colonic Neoplasms/surgery*, Continuity of Patient Care*, Follow-Up Studies, Quality of Life, Patient Satisfaction

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital of North Norway

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Postoperative follow-up of ca coli patients at the surgical outpatient dpt

Postoperative follow-up of ca coli patients by GP's

Outcomes

Primary Outcome Measures

Quality of life; EORTC-QLQ-C30 and EQ 5D

Secondary Outcome Measures

Cost-effectiveness Serious clinical events

Full Information

First Posted
December 11, 2007
Last Updated
January 26, 2016
Sponsor
University Hospital of North Norway
search

1. Study Identification

Unique Protocol Identification Number
NCT00572143
Brief Title
Follow-up After Surgery for Colon Cancer. General Practice vs. Surgical-based Follow-up?
Acronym
ONKOLINK
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

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Colonic Neoplasms/surgery*, Continuity of Patient Care*, Follow-Up Studies, Quality of Life, Patient Satisfaction

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Postoperative follow-up of ca coli patients at the surgical outpatient dpt
Arm Title
2
Arm Type
Active Comparator
Arm Description
Postoperative follow-up of ca coli patients by GP's
Intervention Type
Other
Intervention Name(s)
ca coli follow-up by GP
Intervention Description
patients randomized to follow up by GP
Primary Outcome Measure Information:
Title
Quality of life; EORTC-QLQ-C30 and EQ 5D
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Cost-effectiveness Serious clinical events
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolv-Ole Lindsetmo, MD, PHd
Organizational Affiliation
University of Tromso
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Caroline Sagatun, MD
Organizational Affiliation
Bodø Hospital Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Niels Krum-Hansen
Organizational Affiliation
University Hospital of North Norway (Harstad)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of North Norway
City
Tromsø
ZIP/Postal Code
9037
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
24674307
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.
Results Reference
derived
PubMed Identifier
23564936
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.
Results Reference
derived
PubMed Identifier
18578856
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.
Results Reference
derived

Learn more about this trial

Follow-up After Surgery for Colon Cancer. General Practice vs. Surgical-based Follow-up?

We'll reach out to this number within 24 hrs