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

NCT ID: NCT00572143

Last Updated: 2016-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colon Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

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

Group Type ACTIVE_COMPARATOR

ca coli follow-up by GP

Intervention Type OTHER

patients randomized to follow up by GP

2

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

Group Type ACTIVE_COMPARATOR

ca coli follow-up by GP

Intervention Type OTHER

patients randomized to follow up by GP

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ca coli follow-up by GP

patients randomized to follow up by GP

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital of North Norway

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rolv-Ole Lindsetmo, MD, PHd

Role: STUDY_CHAIR

University of Tromso

Caroline Sagatun, MD

Role: PRINCIPAL_INVESTIGATOR

Bodø Hospital Trust

Niels Krum-Hansen

Role: PRINCIPAL_INVESTIGATOR

University Hospital of North Norway (Harstad)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital of North Norway

Tromsø, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24674307 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23564936 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18578856 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P-REK NORD 79/2006

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.