Implementation of Guidelines on Hereditary or Familial Colorectal Cancer Risk Calculation and Risk Communication
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
The number of colorectal cancer patients following the most optimal follow up program according to the guidelines.
1 year
No
Nicoline Hoogerbrugge, MD, PhD
Principal Investigator
Radboud University
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
ZonMw 80-82315-98-09005
NCT00929097
October 2009
January 2012
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