Implementation of Guidelines on Hereditary or Familial Colorectal Cancer

Colorectal Neoplasms, Hereditary Nonpolyposis Clinical Trial

— RISCO  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00929097
• Other study ID #: ZonMw 80-82315-98-09005
• Status: Unknown status
• Phase: N/A
• First received: June 25, 2009
• Last updated: June 25, 2009
• Start date: October 2009
• Est. completion date: January 2012

Study information

• Verified date: June 2009
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 300
• Est. completion date: January 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Colorectal Neoplasms, Hereditary Nonpolyposis

Intervention

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
• Control
Dissemination of guidelines

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Cardiff University, Comprehensive Cancer Centres, Erasmus Medical Center, Leiden University Medical Center, University Medical Center Groningen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of colorectal cancer patients following the most optimal follow up program according to the guidelines.		1 year
Secondary	The number of patients for whom MSI testing was performed based on the MIPA criteria		1 year
Secondary	The number of CRC patients for whom a correct familial CRC risk is calculated by clinicians (as compared to formally calculated risks)		1 year
Secondary	The number of CRC patients for whom a calculated familial CRC risk is correctly interpreted by clinicians		1 year
Secondary	The number of CRC patients with whom a calculated familial CRC risk and/or follow up policy is communicated by clinicians		1 year
Secondary	Patients' uptake of the follow up policy		1 year
Secondary	Actual exposure to the different elements of the implementation strategy		1 year
Secondary	Experiences of clinicians and patients with the different elements of the implementation strategy		1 year
Secondary	Costs of the implementation procedure		1 year