Implementation of Guidelines on Hereditary or Familial Colorectal Cancer (RISCO)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Cardiff University
Erasmus Medical Center
Leiden University Medical Center
University Medical Centre Groningen
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Comprehensive Cancer Centres
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00929097
First received: June 25, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Colorectal Neoplasms, Hereditary Nonpolyposis
Other: Implementation aids
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Implementation of Guidelines on Hereditary or Familial Colorectal Cancer Risk Calculation and Risk Communication

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • The number of colorectal cancer patients following the most optimal follow up program according to the guidelines. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of patients for whom MSI testing was performed based on the MIPA criteria [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The number of CRC patients for whom a correct familial CRC risk is calculated by clinicians (as compared to formally calculated risks) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The number of CRC patients for whom a calculated familial CRC risk is correctly interpreted by clinicians [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The number of CRC patients with whom a calculated familial CRC risk and/or follow up policy is communicated by clinicians [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Patients' uptake of the follow up policy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Actual exposure to the different elements of the implementation strategy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Experiences of clinicians and patients with the different elements of the implementation strategy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Costs of the implementation procedure [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2009
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Implementation aids Other: Implementation aids
  • Patients and clinicians have access to a website with information on familial colorectal cancer risk; a risk assessment tool and decision aids
  • Clinicians receive the guidelines and a risk communication tool, as well as education
Active Comparator: Control Other: Control
Dissemination of guidelines

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929097

Sponsors and Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
Cardiff University
Erasmus Medical Center
Leiden University Medical Center
University Medical Centre Groningen
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Comprehensive Cancer Centres
Investigators
Principal Investigator: Nicoline Hoogerbrugge, MD, PhD Radboud University
Principal Investigator: Rosella PMG Hermens, PhD Radboud University
  More Information

No publications provided by Radboud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: E.A.R.J. Lohman, Chairman Hospital Board, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00929097     History of Changes
Other Study ID Numbers: ZonMw 80-82315-98-09005
Study First Received: June 25, 2009
Last Updated: June 25, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Colorectal Neoplasms, (Hereditary Nonpolyposis)
Guideline
Health Plan Implementation
Decision Support Techniques
Risk assessment
Familial colorectal cancer risk
Risk assessment tool

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 15, 2014