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Implementation of a New Strategy to Identify HNPCC Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2007 by Radboud University.
Recruitment status was:  Recruiting
Sponsor:
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
  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
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

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141466

Locations
Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Meander Medisch Centrum
Amersfoort, Netherlands
Ziekenhuis Rijnstate
Arnhem, Netherlands
HagaZiekenhuis
Den Haag, Netherlands
Pathologie laboratorium voor Dordrecht
Dordrecht, Netherlands
Stichting laboratoria voor pathologische anatomie en medische microbiologie
Eindhoven, Netherlands
Laboratorium voor pathologie Oost-Nederland
Enschede, Netherlands
Martini Ziekenhuis
Groningen, Netherlands
Elkerliek Ziekenhuis
Helmond, Netherlands
Laboratorium Volksgezondheid Friesland
Leeuwarden, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Medisch Centrum Rijnmond Zuid
Rotterdam, Netherlands
St. Elisabeth Ziekenhuis
Tilburg, Netherlands
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:
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:
Colorectal Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
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 December 09, 2016