Implementation of Guidelines on Hereditary or Familial Colorectal Cancer (RISCO)
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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 |
- 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 ]
- 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
|
| 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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00929097
| 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:
|
Colorectal Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Colonic Diseases DNA Repair-Deficiency Disorders Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms |
Genetic Diseases, Inborn Intestinal Diseases Intestinal Neoplasms Metabolic Diseases Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Rectal Diseases |
ClinicalTrials.gov processed this record on March 03, 2015