Implementation of Guidelines on Hereditary or Familial Colorectal Cancer (RISCO)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Colorectal Neoplasms, Hereditary Nonpolyposis	Other: Implementation aids; Other: Control	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	300 participants
Allocation:	Randomized
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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Implementation aids	Other: Implementation aids; 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
Active Comparator: Control	Other: Control; Dissemination of guidelines

Outcome Measures

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Primary Outcome Measures :

1. The number of colorectal cancer patients following the most optimal follow up program according to the guidelines. [ Time Frame: 1 year ]

Secondary Outcome Measures :

1. The number of patients for whom MSI testing was performed based on the MIPA criteria [ Time Frame: 1 year ]
2. 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 ]
3. The number of CRC patients for whom a calculated familial CRC risk is correctly interpreted by clinicians [ Time Frame: 1 year ]
4. 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 ]
5. Patients' uptake of the follow up policy [ Time Frame: 1 year ]
6. Actual exposure to the different elements of the implementation strategy [ Time Frame: 1 year ]
7. Experiences of clinicians and patients with the different elements of the implementation strategy [ Time Frame: 1 year ]
8. Costs of the implementation procedure [ Time Frame: 1 year ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Cardiff University

Erasmus Medical Center

Leiden University Medical Center

University Medical Center Groningen

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Comprehensive Cancer Centres

Investigators

Principal Investigator:	Nicoline Hoogerbrugge, MD, PhD	Radboud University
Principal Investigator:	Rosella PMG Hermens, PhD	Radboud University

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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
First Posted:	June 26, 2009
Last Update Posted:	June 26, 2009
Last Verified:	June 2009

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; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases	Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; DNA Repair-Deficiency Disorders; Metabolic Diseases