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

Colon Cancer Clinical Trial

— ONKOLINK  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00572143
• Other study ID #: P-REK NORD 79/2006
• Status: Completed
• Phase: N/A
• First received: December 11, 2007
• Last updated: January 26, 2016
• Start date: June 2007
• Est. completion date: June 2013

Study information

• Verified date: January 2016
• Source: University Hospital of North Norway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data ServicesNorway: Directorate of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Colon Cancer

Intervention

Other:
• ca coli follow-up by GP
patients randomized to follow up by GP

Locations

Country	Name	City	State
Norway	University Hospital of North Norway	Tromsø

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life; EORTC-QLQ-C30 and EQ 5D		2 years	No
Secondary	Cost-effectiveness Serious clinical events		2 years	Yes