Implementation of Guidelines on Hereditary or Familial Colorectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Colorectal Neoplasms, Hereditary Nonpolyposis

Intervention / Treatment
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* Other: Implementation aids
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implementation aids<br> | Other: Implementation aids<br>* 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<br>|
| Active Comparator: Control<br> | Other: Control<br>* Dissemination of guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of colorectal cancer patients following the most optimal follow up program according to the guidelines. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Guideline, Colorectal Neoplasms, (Hereditary Nonpolyposis), Health Plan Implementation, Decision Support Techniques, Risk assessment, Familial colorectal cancer risk, Risk assessment tool