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| Name | Class |
|---|---|
| Cardiff University | OTHER |
| Erasmus Medical Center | OTHER |
| Leiden University Medical Center | OTHER |
| University Medical Center Groningen |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implementation aids | Experimental |
| |
| Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implementation aids | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of colorectal cancer patients following the most optimal follow up program according to the guidelines. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients for whom MSI testing was performed based on the MIPA criteria | 1 year | |
| The number of CRC patients for whom a correct familial CRC risk is calculated by clinicians (as compared to formally calculated risks) | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicoline Hoogerbrugge, MD, PhD | Radboud University Medical Center | Principal Investigator |
| Rosella PMG Hermens, PhD | Radboud University Medical Center | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23451840 | Derived | Dekker N, Hermens RP, Nagengast FM, van Zelst-Stams WA, Hoogerbrugge N; RISCO study group. Familial colorectal cancer risk assessment needs improvement for more effective cancer prevention in relatives. Colorectal Dis. 2013 Apr;15(4):e175-85; discussion p.e185. doi: 10.1111/codi.12117. | |
| 20181032 | Derived | Dekker N, Hermens RP, Elwyn G, van der Weijden T, Nagengast FM, van Duijvendijk P, Salemink S, Adang E, van Krieken JH, Ligtenberg MJ, Hoogerbrugge N. Improving calculation, interpretation and communication of familial colorectal cancer risk: protocol for a randomized controlled trial. Implement Sci. 2010 Jan 28;5:6. doi: 10.1186/1748-5908-5-6. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 22, 2013 | |
| Reset | Aug 27, 2013 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 22, 2013 | Aug 27, 2013 |
| ID | Term |
|---|---|
| D003123 | Colorectal Neoplasms, Hereditary Nonpolyposis |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| OTHER |
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
| Comprehensive Cancer Centres | UNKNOWN |
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| Control | Other | Dissemination of guidelines |
|
| The number of CRC patients for whom a calculated familial CRC risk is correctly interpreted by clinicians | 1 year |
| The number of CRC patients with whom a calculated familial CRC risk and/or follow up policy is communicated by clinicians | 1 year |
| Patients' uptake of the follow up policy | 1 year |
| Actual exposure to the different elements of the implementation strategy | 1 year |
| Experiences of clinicians and patients with the different elements of the implementation strategy | 1 year |
| Costs of the implementation procedure | 1 year |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D049914 | DNA Repair-Deficiency Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |