NCT00572143

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2007

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

5.5 years

First QC Date

December 11, 2007

Last Update Submit

January 26, 2016

Conditions

Colon Cancer

Keywords

Colonic Neoplasms/surgery*Continuity of Patient Care*Follow-Up StudiesQuality of LifePatient Satisfaction

Outcome Measures

Primary Outcomes (1)

  • Quality of life; EORTC-QLQ-C30 and EQ 5D

    2 years

Secondary Outcomes (1)

  • Cost-effectiveness Serious clinical events

    2 years

Study Arms (2)

1

ACTIVE COMPARATOR

Postoperative follow-up of ca coli patients at the surgical outpatient dpt

Other: ca coli follow-up by GP

2

ACTIVE COMPARATOR

Postoperative follow-up of ca coli patients by GP's

Other: ca coli follow-up by GP

Interventions

ca coli follow-up by GPOTHER

patients randomized to follow up by GP

12

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, 9037, Norway

Location

Related Publications (3)

  • Augestad KM, Norum J, Rose J, Lindsetmo RO. A prospective analysis of false positive events in a National Colon Cancer Surveillance Program. BMC Health Serv Res. 2014 Mar 27;14:137. doi: 10.1186/1472-6963-14-137.

    PMID: 24674307DERIVED

  • Augestad KM, Norum J, Dehof S, Aspevik R, Ringberg U, Nestvold T, Vonen B, Skrovseth SO, Lindsetmo RO. Cost-effectiveness and quality of life in surgeon versus general practitioner-organised colon cancer surveillance: a randomised controlled trial. BMJ Open. 2013 Apr 4;3(4):e002391. doi: 10.1136/bmjopen-2012-002391. Print 2013.

    PMID: 23564936DERIVED

  • Augestad KM, Vonen B, Aspevik R, Nestvold T, Ringberg U, Johnsen R, Norum J, Lindsetmo RO. Should the surgeon or the general practitioner (GP) follow up patients after surgery for colon cancer? A randomized controlled trial protocol focusing on quality of life, cost-effectiveness and serious clinical events. BMC Health Serv Res. 2008 Jun 25;8:137. doi: 10.1186/1472-6963-8-137.

    PMID: 18578856DERIVED

MeSH Terms

Conditions

Colonic NeoplasmsPatient Satisfaction

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Rolv-Ole Lindsetmo, MD, PHd

    University of Tromso

    STUDY CHAIR

  • Caroline Sagatun, MD

    Bodø Hospital Trust

    PRINCIPAL INVESTIGATOR

  • Niels Krum-Hansen

    University Hospital of North Norway (Harstad)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2007

First Posted

December 12, 2007

Study Start

June 1, 2007

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations

NO(1)