Colorectal NeoplasmsNCT00141466
Implementation of a New Strategy to Identify HNPCC Patients
A study testing Education for professionals, Distribution of educational materials and Feedback for professionals in people with Colorectal Neoplasms and Hereditary Nonpolyposis Colorectal Cancer, run by Radboud University Medical Center at 13 sites in Netherlands.
Trial summary
The purpose of this study is to compare two different strategies to implement a new method to identify patients with HNPCC, which appeared cost-effective and feasible. The effectiveness, costs and feasibility of both of the implementation strategies will be assessed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Neoplasms, Hereditary Nonpolyposis Colorectal Cancer
- What is being tested?
- Education for professionals, Distribution of educational materials and Feedback for professionals
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 360 participants
- Where
- 13 sitesNetherlands
- Study dates
- Sep 2005to Jul 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Colorectal cancer before the age of 50 years
- Second colorectal cancer at any age
- Colorectal cancer and other HNPCC associated extracolonic cancer irrespective of age at diagnosis
- Adenoma with high grade dysplasia diagnosed before the age of 40 years
Who cannot join
None listed.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Netherlands13 sites, 13 recruiting
- Recruiting
Jeroen Bosch Ziekenhuis
's-Hertogenbosch
Stan J Ketelaars, MD
- Recruiting
Meander Medisch Centrum
Amersfoort
Els JM Ahsmann, MD PhD
- Recruiting
Ziekenhuis Rijnstate
Arnhem
Jos Meijer, MD
- Recruiting
Pathologie laboratorium voor Dordrecht
Dordrecht
Pieter J Westenend, MD PhD
- Recruiting
Stichting laboratoria voor pathologische anatomie en medische microbiologie
Eindhoven
Ineke van Lijnschoten, MD PhD
- Recruiting
Laboratorium voor pathologie Oost-Nederland
Enschede
Sietske Riemersma, MD
- Recruiting
Martini Ziekenhuis
Groningen
Ton Tiebosch, MD PhD
- Recruiting
Elkerliek Ziekenhuis
Helmond
Cilia M Ferrier, MD PhD
- Recruiting
Laboratorium Volksgezondheid Friesland
Leeuwarden
Joris J Grond, MD PhD
- Recruiting
Canisius Wilhelmina Ziekenhuis
Nijmegen
Erik Thunnissen, MD PhD
- Recruiting
Medisch Centrum Rijnmond Zuid
Rotterdam
Sonja Henzen, MD PhD
- Recruiting
HagaZiekenhuis
The Hague
Paul Blok, MD PhD
- Recruiting
St. Elisabeth Ziekenhuis
Tilburg
Anneke van der Wurff, MD PhD
About this study
Official title: Cost Effectiveness of Two Different Implementation Procedures to Change Clinicians Practice Roles in the Detection of Hereditary Colorectal Cancer
The purpose of this study is to compare two different strategies to implement a new method to identify patients with HNPCC, which appeared cost-effective and feasible. The effectiveness, costs and feasibility of both of the implementation strategies will be assessed.
Read the detailed description
The Radboud University Nijmegen Medical Centre developed a new method to identify patients with HNPCC. This method appeared cost-effective and feasible. Using this new method 70% of the HNPCC patients will be identified as compared to less than 30% when the current method is used. However, this new method does not implement itself; large gaps exists between best evidence and daily practice. This study will compare an intensive strategy, consisting of distribution of educational materials, education, feedback and reminders, with a minimal strategy, only consisting of distribution of a critical care pathway. The aim is to find the most cost-effective strategy to implement the new method to identify patients with HNPCC in the Netherlands.
- Being tested
- Education for professionals, Distribution of educational materials, Feedback for professionals, Reminders for professionals
- Keywords
- Hereditary colorectal cancer, Microsatellite instability, Physician roles, Health care implementation, Intervention
- Medical subject headings
- Colorectal Neoplasms, Colorectal Neoplasms, Hereditary Nonpolyposis, Microsatellite Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education for professionalsBehavioural
Distribution of educational materialsBehavioural
Feedback for professionalsBehavioural
Reminders for professionalsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of inclusion of eligible CRC-patients for MSI testing by pathologists.
Efficacy of referral of patients who are MSI positive to a clinical geneticist by surgeons.
Secondary outcomes (2)
Experiences with and acceptance of changed physician practice roles by patients and clinicians.
Cost efficacy of the implementation procedures.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startSep 2005
- Study completionJul 2007 (estimated)
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 Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Nicoline Hoogerbrugge, MD PhD, Principal investigator, Department of Human Genetics, Radboud University Nijmegen Medical CenterRosella P Hermens, MSc PhD, Principal investigator, Center of Quality of Care Research, Radboud University Nijmegen Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00141466
- Sponsor's protocol ID
- MIPA-2005
- Other IDs
- ZonMw nr. 945-14-107
- Status last verified
- Feb 2007
- First submitted
- 31 Aug 2005
- Last updated
- 23 Apr 2008
- Results posted
- No
Publications
Kievit W, de Bruin JH, Adang EM, Severens JL, Kleibeuker JH, Sijmons RH, Ruers TJ, Nagengast FM, Vasen HF, van Krieken JH, Ligtenberg MJ, Hoogerbrugge N. Cost effectiveness of a new strategy to identify HNPCC patients. Gut. 2005 Jan;54(1):97-102. doi: 10.1136/gut.2004.039123.
PubMed 15591512de Bruin JH, Kievit W, Ligtenberg MJ, Nagengast FM, Adang EM, Ruers TJ, Kleibeuker JH, Sijmons RH, van Krieken JH, Hoogerbrugge N. [More hereditary intestinal cancer can be detected if patients with colorectal carcinoma that are selected by the pathologist are examined for microsatellite instability]. Ned Tijdschr Geneeskd. 2005 Aug 6;149(32):1792-8. Dutch.
PubMed 16121665Overbeek LI, Hermens RP, van Krieken JH, Adang EM, Casparie M, Nagengast FM, Ligtenberg MJ, Hoogerbrugge N; MIPA study group. Electronic reminders for pathologists promote recognition of patients at risk for Lynch syndrome: cluster-randomised controlled trial. Virchows Arch. 2010 Jun;456(6):653-9. doi: 10.1007/s00428-010-0907-7. Epub 2010 Apr 9.
PubMed 20379742
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Effectiveness of Two Different Implementation Procedures to Change Clinicians Practice Roles in the Detection of Hereditary Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00141466
- Acronym / sponsor ID
- MIPA-2005
- Keywords
- Hereditary colorectal cancer, Microsatellite instability, Physician roles, Health care implementation, Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Sep 2005
- Study completion
- Jul 2007 (estimated)
- First posted
- 1 Sep 2005 (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 compare two different strategies to implement a new method to identify patients with HNPCC, which appeared cost-effective and feasible. The effectiveness, costs and feasibility of both of the implementation strategies will be assessed.
Detailed description
The Radboud University Nijmegen Medical Centre developed a new method to identify patients with HNPCC. This method appeared cost-effective and feasible. Using this new method 70% of the HNPCC patients will be identified as compared to less than 30% when the current method is used. However, this new method does not implement itself; large gaps exists between best evidence and daily practice. This study will compare an intensive strategy, consisting of distribution of educational materials, education, feedback and reminders, with a minimal strategy, only consisting of distribution of a critical care pathway. The aim is to find the most cost-effective strategy to implement the new method to identify patients with HNPCC in the Netherlands.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Colorectal cancer before the age of 50 years
- Second colorectal cancer at any age
- Colorectal cancer and other HNPCC associated extracolonic cancer irrespective of age at diagnosis
- Adenoma with high grade dysplasia diagnosed before the age of 40 years
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Education for professionals | Behavioural | – |
| Distribution of educational materials | Behavioural | – |
| Feedback for professionals | Behavioural | – |
| Reminders for professionals | Behavioural | – |
Primary outcome
Efficacy of inclusion of eligible CRC-patients for MSI testing by pathologists.
Efficacy of referral of patients who are MSI positive to a clinical geneticist by surgeons.
2 secondary outcomes
Experiences with and acceptance of changed physician practice roles by patients and clinicians.
Cost efficacy of the implementation procedures.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2008.
- Background: PubMed 15591512Kievit W, de Bruin JH, Adang EM, Severens JL, Kleibeuker JH, Sijmons RH, Ruers TJ, Nagengast FM, Vasen HF, van Krieken JH, Ligtenberg MJ, Hoogerbrugge N. Cost effectiveness of a new strategy to identify HNPCC patients. Gut. 2005 Jan;54(1):97-102. doi: 10.1136/gut.2004.039123.
- Background: PubMed 16121665de Bruin JH, Kievit W, Ligtenberg MJ, Nagengast FM, Adang EM, Ruers TJ, Kleibeuker JH, Sijmons RH, van Krieken JH, Hoogerbrugge N. [More hereditary intestinal cancer can be detected if patients with colorectal carcinoma that are selected by the pathologist are examined for microsatellite instability]. Ned Tijdschr Geneeskd. 2005 Aug 6;149(32):1792-8. Dutch.
- Derived from this study: PubMed 20379742Overbeek LI, Hermens RP, van Krieken JH, Adang EM, Casparie M, Nagengast FM, Ligtenberg MJ, Hoogerbrugge N; MIPA study group. Electronic reminders for pathologists promote recognition of patients at risk for Lynch syndrome: cluster-randomised controlled trial. Virchows Arch. 2010 Jun;456(6):653-9. doi: 10.1007/s00428-010-0907-7. Epub 2010 Apr 9.
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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.
Nicoline Hoogerbrugge, MD PhD principal investigator
Department of Human Genetics, Radboud University Nijmegen Medical Center
Rosella P Hermens, MSc PhD principal investigator
Center of Quality of Care Research, Radboud University Nijmegen Medical Center
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education for professionals, Distribution of educational materials and Feedback for professionals in people with Colorectal Neoplasms and Hereditary Nonpolyposis Colorectal Cancer, run by Radboud University Medical Center at 13 sites in Netherlands.
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 4 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 23 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucy I Overbeek, MSc (+31-24-3613946, l.overbeek@antrg.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of inclusion of eligible CRC-patients for MSI testing by pathologists.. The study lists 2 primary outcomes in all. 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 NCT00141466, 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 23 Apr 2008.