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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University Hospital of North Norway.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT00572143
First received: December 11, 2007
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

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 Intervention
Colon Cancer
Other: ca coli follow-up by GP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Quality of life; EORTC-QLQ-C30 and EQ 5D [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost-effectiveness Serious clinical events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: June 2007
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572143

Locations
Norway
University Hospital of North Norway
Tromsø, Norway, 9037
Sponsors and Collaborators
University Hospital of North Norway
Investigators
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

No publications provided by University Hospital of North Norway

Additional 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
Study First Received: December 11, 2007
Last Updated: April 4, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Social Science Data Services
Norway: Directorate of Health

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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 29, 2014