Implementation of Guidelines on Hereditary or Familial Colorectal Cancer (RISCO)
Primary Purpose
Colorectal Neoplasms, Hereditary Nonpolyposis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Implementation aids
Control
Sponsored by
About this trial
This is an interventional health services research trial for Colorectal Neoplasms, Hereditary Nonpolyposis focused on measuring Colorectal Neoplasms, (Hereditary Nonpolyposis), Guideline, Health Plan Implementation, Decision Support Techniques, Risk assessment, Familial colorectal cancer risk, Risk assessment tool
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Implementation aids
Control
Arm Description
Outcomes
Primary Outcome Measures
The number of colorectal cancer patients following the most optimal follow up program according to the guidelines.
Secondary Outcome Measures
The number of patients for whom MSI testing was performed based on the MIPA criteria
The number of CRC patients for whom a correct familial CRC risk is calculated by clinicians (as compared to formally calculated risks)
The number of CRC patients for whom a calculated familial CRC risk is correctly interpreted by clinicians
The number of CRC patients with whom a calculated familial CRC risk and/or follow up policy is communicated by clinicians
Patients' uptake of the follow up policy
Actual exposure to the different elements of the implementation strategy
Experiences of clinicians and patients with the different elements of the implementation strategy
Costs of the implementation procedure
Full Information
NCT ID
NCT00929097
First Posted
June 25, 2009
Last Updated
June 25, 2009
Sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborators
Cardiff University, Erasmus Medical Center, Leiden University Medical Center, University Medical Center Groningen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Comprehensive Cancer Centres
1. Study Identification
Unique Protocol Identification Number
NCT00929097
Brief Title
Implementation of Guidelines on Hereditary or Familial Colorectal Cancer
Acronym
RISCO
Official Title
Implementation of Guidelines on Hereditary or Familial Colorectal Cancer Risk Calculation and Risk Communication
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
January 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborators
Cardiff University, Erasmus Medical Center, Leiden University Medical Center, University Medical Center Groningen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Comprehensive Cancer Centres
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms, Hereditary Nonpolyposis
Keywords
Colorectal Neoplasms, (Hereditary Nonpolyposis), Guideline, Health Plan Implementation, Decision Support Techniques, Risk assessment, Familial colorectal cancer risk, Risk assessment tool
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Implementation aids
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Implementation aids
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Dissemination of guidelines
Primary Outcome Measure Information:
Title
The number of colorectal cancer patients following the most optimal follow up program according to the guidelines.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The number of patients for whom MSI testing was performed based on the MIPA criteria
Time Frame
1 year
Title
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
Title
The number of CRC patients for whom a calculated familial CRC risk is correctly interpreted by clinicians
Time Frame
1 year
Title
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
Title
Patients' uptake of the follow up policy
Time Frame
1 year
Title
Actual exposure to the different elements of the implementation strategy
Time Frame
1 year
Title
Experiences of clinicians and patients with the different elements of the implementation strategy
Time Frame
1 year
Title
Costs of the implementation procedure
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicoline Hoogerbrugge, MD, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rosella PMG Hermens, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
23451840
Citation
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.
Results Reference
derived
PubMed Identifier
20181032
Citation
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.
Results Reference
derived
Learn more about this trial
Implementation of Guidelines on Hereditary or Familial Colorectal Cancer
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