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Implementation of Guidelines on Hereditary or Familial Colorectal Cancer Risk Calculation and Risk Communication

18 Years
70 Years
Open (Enrolling by invite only)
Colorectal Neoplasms, Hereditary Nonpolyposis

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Trial Information

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

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

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

The number of colorectal cancer patients following the most optimal follow up program according to the guidelines.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Nicoline Hoogerbrugge, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radboud University


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

ZonMw 80-82315-98-09005



Start Date:

October 2009

Completion Date:

January 2012

Related Keywords:

  • Colorectal Neoplasms, Hereditary Nonpolyposis
  • Colorectal Neoplasms, (Hereditary Nonpolyposis)
  • Guideline
  • Health Plan Implementation
  • Decision Support Techniques
  • Risk assessment
  • Familial colorectal cancer risk
  • Risk assessment tool
  • Neoplasms
  • Colorectal Neoplasms
  • Colorectal Neoplasms, Hereditary Nonpolyposis