Skip to content

Implementation of Guidelines on Hereditary or Familial Colorectal Cancer

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00929097
Acronym
RISCO
Enrollment
300
Registered
2009-06-26
Start date
2009-10-31
Completion date
2012-01-31
Last updated
2009-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

* 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

OTHERControl

Dissemination of guidelines

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The number of colorectal cancer patients following the most optimal follow up program according to the guidelines.1 year

Secondary

MeasureTime frame
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 clinicians1 year
The number of CRC patients with whom a calculated familial CRC risk and/or follow up policy is communicated by clinicians1 year
The number of patients for whom MSI testing was performed based on the MIPA criteria1 year
Actual exposure to the different elements of the implementation strategy1 year
Experiences of clinicians and patients with the different elements of the implementation strategy1 year
Costs of the implementation procedure1 year
Patients' uptake of the follow up policy1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026