Follow-up After Surgery for Colon Cancer. General Practice vs. Surgical-based Follow-up? (ONKOLINK)
This study is ongoing, but not recruiting participants.
Sponsor:
University Hospital of North Norway
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
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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
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 June 18, 2013