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

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ClinicalTrials.gov Identifier: NCT00572143
Recruitment Status : Completed
First Posted : December 12, 2007
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital of North Norway

Tracking Information
First Submitted Date  ICMJE December 11, 2007
First Posted Date  ICMJE December 12, 2007
Last Update Posted Date January 27, 2016
Study Start Date  ICMJE June 2007
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2007)
Quality of life; EORTC-QLQ-C30 and EQ 5D [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2007)
Cost-effectiveness Serious clinical events [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Follow-up After Surgery for Colon Cancer. General Practice vs. Surgical-based Follow-up?
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Colon Cancer
Intervention  ICMJE Other: ca coli follow-up by GP
patients randomized to follow up by GP
Study Arms  ICMJE
  • Active Comparator: 1
    Postoperative follow-up of ca coli patients at the surgical outpatient dpt
    Intervention: Other: ca coli follow-up by GP
  • Active Comparator: 2
    Postoperative follow-up of ca coli patients by GP's
    Intervention: Other: ca coli follow-up by GP
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2007)
180
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00572143
Other Study ID Numbers  ICMJE P-REK NORD 79/2006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital of North Norway
Study Sponsor  ICMJE University Hospital of North Norway
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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)
PRS Account University Hospital of North Norway
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP