Implementation of a New Strategy to Identify HNPCC Patients - Full Text View

Sponsors and Collaborators:	Radboud University ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00141466

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

Genetics Home Reference related topics: Lynch syndrome

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Cost Effectiveness of Two Different Implementation Procedures to Change Clinicians Practice Roles in the Detection of Hereditary Colorectal Cancer

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

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.

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
St. Elisabeth Ziekenhuis	Recruiting
Tilburg, Netherlands
Contact: Anneke van der Wurff, MD PhD
Laboratorium voor pathologie Oost-Nederland	Recruiting
Enschede, Netherlands
Contact: Sietske Riemersma, MD
Elkerliek Ziekenhuis	Recruiting
Helmond, Netherlands
Contact: Cilia M Ferrier, MD PhD
Jeroen Bosch Ziekenhuis	Recruiting
's-Hertogenbosch, Netherlands
Contact: Stan J Ketelaars, MD
Ziekenhuis Rijnstate	Recruiting
Arnhem, Netherlands
Contact: Jos Meijer, MD
Canisius Wilhelmina Ziekenhuis	Recruiting
Nijmegen, Netherlands
Contact: Erik Thunnissen, MD PhD
Meander Medisch Centrum	Recruiting
Amersfoort, Netherlands
Contact: Els JM Ahsmann, MD PhD
Laboratorium Volksgezondheid Friesland	Recruiting
Leeuwarden, Netherlands
Contact: Joris J Grond, MD PhD
Martini Ziekenhuis	Recruiting
Groningen, Netherlands
Contact: Ton Tiebosch, MD PhD
Pathologie laboratorium voor Dordrecht	Recruiting
Dordrecht, Netherlands
Contact: Pieter J Westenend, MD PhD
HagaZiekenhuis	Recruiting
Den Haag, Netherlands
Contact: Paul Blok, MD PhD
Medisch Centrum Rijnmond Zuid	Recruiting
Rotterdam, Netherlands
Contact: Sonja Henzen, MD PhD
Stichting laboratoria voor pathologische anatomie en medische microbiologie	Recruiting
Eindhoven, Netherlands
Contact: Ineke van Lijnschoten, 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:

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.

de 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.

Study ID Numbers:	MIPA-2005, ZonMw nr. 945-14-107
Study First Received:	August 31, 2005
Last Updated:	April 22, 2008
ClinicalTrials.gov Identifier:	NCT00141466
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

Study placed in the following topic categories:

Metabolic Diseases
Digestive System Neoplasms
Microsatellite Instability
Gastrointestinal Diseases
Colonic Diseases
Hereditary nonpolyposis colon cancer
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms

Digestive System Diseases
Neoplastic Syndromes, Hereditary
Colorectal Neoplasms, Hereditary Nonpolyposis
Genetic Diseases, Inborn
Colorectal cancer, hereditary nonpolyposis, type 1
Gastrointestinal Neoplasms
Metabolic disorder
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
DNA Repair-Deficiency Disorders

ClinicalTrials.gov processed this record on January 13, 2009