Implementation of a New Strategy to Identify HNPCC Patients

Not Applicable

• Conditions: Colorectal Neoplasms; Hereditary Nonpolyposis Colorectal Cancer

• Registration Number: NCT00141466
• Lead Sponsor: Radboud University Medical Center

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.

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 Timeline

• Study First Submitted: 2005-08-31
• Study First Submitted QC: 2005-08-31
• Study Start: 2005-09
• Study First Posted: 2005-09-01
• Status Verified: 2007-02
• Study Completion: 2007-07
• Last Update Submitted: 2008-04-22
• Last Update Posted: 2008-04-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Experiences with and acceptance of changed physician practice roles by patients and clinicians.
Cost efficacy of the implementation procedures.

Trial Locations

Locations (13)

Ziekenhuis Rijnstate; 🇳🇱 Arnhem, Netherlands

HagaZiekenhuis; 🇳🇱 Den Haag, Netherlands

Martini Ziekenhuis; 🇳🇱 Groningen, Netherlands

Meander Medisch Centrum; 🇳🇱 Amersfoort, Netherlands

Canisius Wilhelmina Ziekenhuis; 🇳🇱 Nijmegen, Netherlands

Jeroen Bosch Ziekenhuis; 🇳🇱 's-Hertogenbosch, Netherlands

Pathologie laboratorium voor Dordrecht; 🇳🇱 Dordrecht, Netherlands

Laboratorium voor pathologie Oost-Nederland; 🇳🇱 Enschede, Netherlands

Elkerliek Ziekenhuis; 🇳🇱 Helmond, Netherlands

Laboratorium Volksgezondheid Friesland; 🇳🇱 Leeuwarden, Netherlands

Medisch Centrum Rijnmond Zuid; 🇳🇱 Rotterdam, Netherlands

St. Elisabeth Ziekenhuis; 🇳🇱 Tilburg, Netherlands

Stichting laboratoria voor pathologische anatomie en medische microbiologie; 🇳🇱 Eindhoven, Netherlands