Implementation of Guidelines on Hereditary or Familial Colorectal Cancer (RISCO)
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|ClinicalTrials.gov Identifier: NCT00929097|
Recruitment Status : Unknown
Verified June 2009 by Radboud University.
Recruitment status was: Enrolling by invitation
First Posted : June 26, 2009
Last Update Posted : June 26, 2009
|Condition or disease||Intervention/treatment|
|Colorectal Neoplasms, Hereditary Nonpolyposis||Other: Implementation aids Other: Control|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Implementation of Guidelines on Hereditary or Familial Colorectal Cancer Risk Calculation and Risk Communication|
|Study Start Date :||October 2009|
|Estimated Primary Completion Date :||July 2011|
|Estimated Study Completion Date :||January 2012|
|Experimental: Implementation aids||
Other: Implementation aids
|Active Comparator: Control||
Dissemination of guidelines
- The number of colorectal cancer patients following the most optimal follow up program according to the guidelines. [ Time Frame: 1 year ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929097
|Principal Investigator:||Nicoline Hoogerbrugge, MD, PhD||Radboud University|
|Principal Investigator:||Rosella PMG Hermens, PhD||Radboud University|