Clinical Trial: Implementation of Guidelines on Hereditary or Familial Colorectal Cancer

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:

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.


Sponsor: ZonMw: The Netherlands Organisation for Health Research and Development

Current Primary Outcome: The number of colorectal cancer patients following the most optimal follow up program according to the guidelines. [ Time Frame: 1 year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The number of patients for whom MSI testing was performed based on the MIPA criteria [ Time Frame: 1 year ]
  • 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 ]
  • The number of CRC patients for whom a calculated familial CRC risk is correctly interpreted by clinicians [ Time Frame: 1 year ]
  • 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 ]
  • Patients' uptake of the follow up policy [ Time Frame: 1 year ]
  • Actual exposure to the different elements of the implementation strategy [ Time Frame: 1 year ]
  • Experiences of clinicians and patients with the different elements of the implementation strategy [ Time Frame: 1 year ]
  • Costs of the implementation procedure [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

Information By: Radboud University

Dates:
Date Received: June 25, 2009
Date Started: October 2009
Date Completion: January 2012
Last Updated: June 25, 2009
Last Verified: June 2009