Implementation of a New Strategy to Identify HNPCC Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00141466
Recruitment Status : Unknown
Verified February 2007 by Radboud University.
Recruitment status was:  Recruiting
First Posted : September 1, 2005
Last Update Posted : April 23, 2008
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Radboud University

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Hereditary Nonpolyposis Colorectal Cancer Behavioral: Education for professionals Behavioral: Distribution of educational materials Behavioral: Feedback for professionals Behavioral: Reminders for professionals Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Official Title: Cost Effectiveness of Two Different Implementation Procedures to Change Clinicians Practice Roles in the Detection of Hereditary Colorectal Cancer
Study Start Date : September 2005
Estimated Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Efficacy of inclusion of eligible CRC-patients for MSI testing by pathologists.
  2. Efficacy of referral of patients who are MSI positive to a clinical geneticist by surgeons.

Secondary Outcome Measures :
  1. Experiences with and acceptance of changed physician practice roles by patients and clinicians.
  2. Cost efficacy of the implementation procedures.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00141466

Contact: Lucy I Overbeek, MSc +31-24-3613946
Contact: Nicoline Hoogerbrugge, MD PhD +31-24-3613946

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
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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00141466     History of Changes
Other Study ID Numbers: MIPA-2005
ZonMw nr. 945-14-107
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: April 23, 2008
Last Verified: February 2007

Keywords provided by Radboud University:
Hereditary colorectal cancer
Microsatellite instability
Physician roles
Health care implementation

Additional relevant MeSH terms:
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