Implementation of a New Strategy to Identify HNPCC Patients

April 22, 2008 updated by: Radboud University Medical Center

Cost Effectiveness of Two Different Implementation Procedures to Change Clinicians Practice Roles in the Detection of Hereditary Colorectal Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Experiences with and acceptance of changed physician practice roles by patients and clinicians.
Cost efficacy of the implementation procedures.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion (Anticipated)

July 1, 2007

Study Registration Dates

First Submitted

August 31, 2005

First Submitted That Met QC Criteria

August 31, 2005

First Posted (Estimate)

September 1, 2005

Study Record Updates

Last Update Posted (Estimate)

April 23, 2008

Last Update Submitted That Met QC Criteria

April 22, 2008

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIPA-2005
  • ZonMw nr. 945-14-107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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