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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00572143
Recruitment Status : Completed
First Posted : December 12, 2007
Last Update Posted : January 27, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Colon Cancer Other: ca coli follow-up by GP

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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 Start Date : June 2007
Primary Completion Date : December 2012
Study Completion Date : June 2013
Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Postoperative follow-up of ca coli patients at the surgical outpatient dpt
Other: ca coli follow-up by GP
patients randomized to follow up by GP
Active Comparator: 2
Postoperative follow-up of ca coli patients by GP`s
Other: ca coli follow-up by GP
patients randomized to follow up by GP

Outcome Measures

Primary Outcome Measures :
  1. Quality of life; EORTC-QLQ-C30 and EQ 5D [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Cost-effectiveness Serious clinical events [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00572143

University Hospital of North Norway
Tromsø, Norway, 9037
Sponsors and Collaborators
University Hospital of North Norway
Study Chair: Rolv-Ole Lindsetmo, MD, PHd University of Tromso
Principal Investigator: Caroline Sagatun, MD Bodø Hospital Trust
Principal Investigator: Niels Krum-Hansen University Hospital of North Norway (Harstad)
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT00572143     History of Changes
Other Study ID Numbers: P-REK NORD 79/2006
First Posted: December 12, 2007    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016

Keywords provided by University Hospital of North Norway:
Colonic Neoplasms/surgery*
Continuity of Patient Care*
Follow-Up Studies
Quality of Life
Patient Satisfaction

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases