Implementation of a New Strategy to Identify HNPCC Patients

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00141466
• Other study ID #: MIPA-2005
• Secondary ID: ZonMw nr. 945-14
• Status: Recruiting
• Phase: N/A
• First received: August 31, 2005
• Last updated: April 22, 2008
• Start date: September 2005
• Est. completion date: July 2007

Study information

• Verified date: February 2007
• Source: Radboud University
• Contact: Lucy I Overbeek, MSc
• Phone: +31-24-3613946
• Email: l.overbeek[@]antrg.umcn.nl
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Colorectal Neoplasms, Hereditary Nonpolyposis
• Hereditary Nonpolyposis Colorectal Cancer

Intervention

Behavioral:
• Education for professionals

• Distribution of educational materials

• Feedback for professionals

• Reminders for professionals

Locations

Country	Name	City	State
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

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of inclusion of eligible CRC-patients for MSI testing by pathologists.
Primary	Efficacy of referral of patients who are MSI positive to a clinical geneticist by surgeons.
Secondary	Experiences with and acceptance of changed physician practice roles by patients and clinicians.
Secondary	Cost efficacy of the implementation procedures.