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

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Neoplasms, Hereditary Nonpolyposis
• Intervention / Treatment: Other: Implementation aids; Other: Control

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control	Other: Control; Dissemination of guidelines
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: ZonMw: The Netherlands Organisation for Health Research and Development
• Collaborators: Cardiff University; University Medical Center Groningen; Erasmus Medical Center; Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Leiden University Medical Center; Comprehensive Cancer Centres
• Investigators: Principal Investigator: Nicoline Hoogerbrugge, MD, PhD, Radboud University Medical Center; Principal Investigator: Rosella PMG Hermens, PhD, Radboud University Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Anticipated): July 1, 2011
• Study Completion (Anticipated): January 1, 2012

Study Registration Dates

• First Submitted: June 25, 2009
• First Submitted That Met QC Criteria: June 25, 2009
• First Posted (Estimate): June 26, 2009

Study Record Updates

• Last Update Posted (Estimate): June 26, 2009
• Last Update Submitted That Met QC Criteria: June 25, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: Risk assessment; Guideline; Decision Support Techniques; Health Plan Implementation; Colorectal Neoplasms, (Hereditary Nonpolyposis); Familial colorectal cancer risk; Risk assessment tool
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Genetic Diseases, Inborn; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Syndromes, Hereditary; DNA Repair-Deficiency Disorders; Colorectal Neoplasms; Colorectal Neoplasms, Hereditary Nonpolyposis
• Other Study ID Numbers: ZonMw 80-82315-98-09005