Implementation of Guidelines on Hereditary or Familial Colorectal Cancer

Not Applicable

• Conditions: Colorectal Neoplasms, Hereditary Nonpolyposis
• Interventions: Other: Implementation aids; Other: Control

• Registration Number: NCT00929097
• Lead Sponsor: ZonMw: The Netherlands Organisation for Health Research and Development

Brief Summary

The aim of this study is to improve clinicians' calculation, interpretation and communication of familial colorectal cancer risk, as well as patients' risk perception and uptake of referral for genetic counselling or for surveillance by colonoscopy for their relatives at risk.

Detailed Description

Regular colonoscopy is effective in reducing morbidity and mortality due to colorectal cancer (CRC) in patients at increased familial CRC risk. Currently, the majority of these at-risk individuals are not properly referred for increased surveillance by colonoscopy or genetic counselling. In 2008, a national multidisciplinary evidence-based guideline on familial and hereditary CRC was launched in the Netherlands. Clinicians have new tasks in familial CRC risk calculation, interpretation and communication. A clustered randomized controlled trial including an effect, process and cost evaluation will be conducted in eighteen Dutch hospitals to determine the most cost effective way to implement these new guidelines.

Surgeons and gastroenterologists in both the intervention group and the control group will receive background information on familial colorectal cancer risk and the guidelines. Patients and clinicians in the intervention group will receive an additional intervention strategy.

The effect evaluation is done by assessing the number of CRC patients for whom correct risk calculation, interpretation and communication is performed, as well as patients' uptake of the recommended follow up policy. The actual exposure to the different elements of the implementation procedure and the experiences of users will be assessed in the process evaluation. The costs of the implementation procedure will be determined by means of a cost evaluation.

Study Timeline

• Status Verified: 2009-06
• Study First Submitted: 2009-06-25
• Study First Submitted QC: 2009-06-25
• Last Update Submitted: 2009-06-25
• Study First Posted: 2009-06-26
• Last Update Posted: 2009-06-26
• Study Start: 2009-10
• Primary Completion: 2011-07
• Study Completion: 2012-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Clinical diagnosis of colorectal cancer before the age of 70
• Diagnosed in one of the participating hospitals
• Able to read and understand Dutch

Exclusion Criteria

• Previous referral for genetic counseling

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Implementation aids	Implementation aids	-
Control	Control	-

Primary Outcome Measures

Name	Time	Method
The number of colorectal cancer patients following the most optimal follow up program according to the guidelines.	1 year

Secondary Outcome Measures

Name	Time	Method
The number of patients for whom MSI testing was performed based on the MIPA criteria	1 year
The number of CRC patients for whom a correct familial CRC risk is calculated by clinicians (as compared to formally calculated risks)	1 year
The number of CRC patients for whom a calculated familial CRC risk is correctly interpreted by clinicians	1 year
The number of CRC patients with whom a calculated familial CRC risk and/or follow up policy is communicated by clinicians	1 year
Patients' uptake of the follow up policy	1 year
Actual exposure to the different elements of the implementation strategy	1 year
Experiences of clinicians and patients with the different elements of the implementation strategy	1 year
Costs of the implementation procedure	1 year