NCT00572143CompletedNot Applicable
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.
University Hospital of North Norway1 site in 1 country180 target enrollmentStarted: June 1, 2007Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Quality of life; EORTC-QLQ-C30 and EQ 5D
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
1
Active Comparator
Postoperative follow-up of ca coli patients at the surgical outpatient dpt
Intervention: ca coli follow-up by GP (Other)
2
Active Comparator
Postoperative follow-up of ca coli patients by GP's
Intervention: ca coli follow-up by GP (Other)
Outcomes
Primary Outcomes
Quality of life; EORTC-QLQ-C30 and EQ 5D
Time Frame: 2 years
Secondary Outcomes
- Cost-effectiveness Serious clinical events(2 years)
Investigators
Study Sites (1)
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