Colon CancerONKOLINKNCT00572143
Follow-up After Surgery for Colon Cancer. General Practice vs. Surgical-based Follow-up?
A study testing ca coli follow-up by GP in people with Colon Cancer, run by University Hospital of North Norway at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- ca coli follow-up by GP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2007to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Colon Cancer
- Being tested
- ca coli follow-up by GP
- Keywords
- Colonic Neoplasms/surgery*, Continuity of Patient Care*, Follow-Up Studies, Quality of Life, Patient Satisfaction
- Medical subject headings
- Colonic Neoplasms, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ca coli follow-up by GPOther
patients randomized to follow up by GP
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Postoperative follow-up of ca coli patients at the surgical outpatient dpt Receives: Other: ca coli follow-up by GP |
| 2 | Active comparator | Postoperative follow-up of ca coli patients by GP's Receives: Other: ca coli follow-up by GP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life; EORTC-QLQ-C30 and EQ 5D
Measured: 2 years
Secondary outcomes (1)
Cost-effectiveness Serious clinical events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startJun 2007
- Primary completionDec 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rolv-Ole Lindsetmo, MD, PHd, Study chair, University of TromsoCaroline Sagatun, MD, Principal investigator, Bodø Hospital TrustNiels Krum-Hansen, Principal investigator, University Hospital of North Norway (Harstad)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00572143
- Sponsor's protocol ID
- P-REK NORD 79/2006
- Acronym
- ONKOLINK
- Status last verified
- Jan 2016
- First submitted
- 11 Dec 2007
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24674307Augestad 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.
PubMed 23564936Augestad 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.
PubMed 18578856
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00572143
- Acronym / sponsor ID
- ONKOLINK / P-REK NORD 79/2006
- Conditions
- Colon Cancer
- Keywords
- Colonic Neoplasms/surgery*, Continuity of Patient Care*, Follow-Up Studies, Quality of Life, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 12 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: ca coli follow-up by GPPostoperative follow-up of ca coli patients at the surgical outpatient dpt |
| 2 | Active comparator | Other: ca coli follow-up by GPPostoperative follow-up of ca coli patients by GP's |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ca coli follow-up by GPpatients randomized to follow up by GP | Other | 1, 2 |
Primary outcome
Quality of life; EORTC-QLQ-C30 and EQ 5D
Time frame: 2 years
1 secondary outcome
Cost-effectiveness Serious clinical events
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Derived from this study: PubMed 24674307Augestad 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.
- Derived from this study: PubMed 23564936Augestad 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.
- Derived from this study: PubMed 18578856Augestad 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.
Related trials for Colon Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolv-Ole Lindsetmo, MD, PHd study chair
University of Tromso
Caroline Sagatun, MD principal investigator
Bodø Hospital Trust
Niels Krum-Hansen principal investigator
University Hospital of North Norway (Harstad)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ca coli follow-up by GP in people with Colon Cancer, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life; EORTC-QLQ-C30 and EQ 5D (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00572143, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2016.