Implementation of a New Strategy to Identify HNPCC Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Radboud University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Radboud University
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00141466
First received: August 31, 2005
Last updated: April 22, 2008
Last verified: February 2007
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Colorectal Neoplasms Hereditary Nonpolyposis Colorectal Cancer |
Behavioral: Education for professionals Behavioral: Distribution of educational materials Behavioral: Feedback for professionals Behavioral: Reminders for professionals |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind |
| Official Title: | Cost Effectiveness of Two Different Implementation Procedures to Change Clinicians Practice Roles in the Detection of Hereditary Colorectal Cancer |
Resource links provided by NLM:
Further study details as provided by Radboud University:
Primary Outcome Measures:
- 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 Outcome Measures:
- Experiences with and acceptance of changed physician practice roles by patients and clinicians.
- Cost efficacy of the implementation procedures.
| Estimated Enrollment: | 360 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | July 2007 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141466
Contacts
| Contact: Lucy I Overbeek, MSc | +31-24-3613946 | l.overbeek@antrg.umcn.nl |
| Contact: Nicoline Hoogerbrugge, MD PhD | +31-24-3613946 | n.hoogerbrugge@antrg.umcn.nl |
Locations
| Netherlands | |
| Jeroen Bosch Ziekenhuis | Recruiting |
| 's-Hertogenbosch, Netherlands | |
| Contact: Stan J Ketelaars, MD | |
| Meander Medisch Centrum | Recruiting |
| Amersfoort, Netherlands | |
| Contact: Els JM Ahsmann, MD PhD | |
| Ziekenhuis Rijnstate | Recruiting |
| Arnhem, Netherlands | |
| Contact: Jos Meijer, MD | |
| HagaZiekenhuis | Recruiting |
| Den Haag, Netherlands | |
| Contact: Paul Blok, MD PhD | |
| Pathologie laboratorium voor Dordrecht | Recruiting |
| Dordrecht, Netherlands | |
| Contact: Pieter J Westenend, MD PhD | |
| Stichting laboratoria voor pathologische anatomie en medische microbiologie | Recruiting |
| Eindhoven, Netherlands | |
| Contact: Ineke van Lijnschoten, MD PhD | |
| Laboratorium voor pathologie Oost-Nederland | Recruiting |
| Enschede, Netherlands | |
| Contact: Sietske Riemersma, MD | |
| Martini Ziekenhuis | Recruiting |
| Groningen, Netherlands | |
| Contact: Ton Tiebosch, MD PhD | |
| Elkerliek Ziekenhuis | Recruiting |
| Helmond, Netherlands | |
| Contact: Cilia M Ferrier, MD PhD | |
| Laboratorium Volksgezondheid Friesland | Recruiting |
| Leeuwarden, Netherlands | |
| Contact: Joris J Grond, MD PhD | |
| Canisius Wilhelmina Ziekenhuis | Recruiting |
| Nijmegen, Netherlands | |
| Contact: Erik Thunnissen, MD PhD | |
| Medisch Centrum Rijnmond Zuid | Recruiting |
| Rotterdam, Netherlands | |
| Contact: Sonja Henzen, MD PhD | |
| St. Elisabeth Ziekenhuis | Recruiting |
| Tilburg, Netherlands | |
| Contact: Anneke van der Wurff, MD PhD | |
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
| Principal Investigator: | Nicoline Hoogerbrugge, MD PhD | Department of Human Genetics, Radboud University Nijmegen Medical Center |
| Principal Investigator: | Rosella P Hermens, MSc PhD | Center of Quality of Care Research, Radboud University Nijmegen Medical Center |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00141466 History of Changes |
| Other Study ID Numbers: | MIPA-2005, ZonMw nr. 945-14-107 |
| Study First Received: | August 31, 2005 |
| Last Updated: | April 22, 2008 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
Hereditary colorectal cancer Microsatellite instability Physician roles Health care implementation Intervention |
Additional relevant MeSH terms:
|
Neoplasms Colorectal Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn DNA Repair-Deficiency Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013