NCT00929097

Implementation of Guidelines on Hereditary or Familial Colorectal Cancer

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: ZonMw: The Netherlands Organisation for Health Research and Development · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Neoplasms, Hereditary Nonpolyposis

Interventions

Type	Name	Description
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
OTHER	Control	Dissemination of guidelines

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-07-01
• Completion: 2012-01-01
• First posted: 2009-06-26
• Last updated: 2009-06-26