Clinical trial NCT00929097: Implementation of Guidelines on Hereditary or Familial Colorectal Cancer
Official title: Implementation of Guidelines on Hereditary or Familial Colorectal Cancer Risk Calculation and Risk Communication
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Cardiff University
name: Erasmus Medical Center
name: Leiden University Medical Center
name: University Medical Center Groningen
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Comprehensive Cancer Centres
First posted: 2009-06-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: The number of colorectal cancer patients following the most optimal follow up program according to the guidelines.
timeFrame: 1 year
Secondary outcomes:
measure: The number of patients for whom MSI testing was performed based on the MIPA criteria
timeFrame: 1 year
measure: The number of CRC patients for whom a correct familial CRC risk is calculated by clinicians (as compared to formally calculated risks)
timeFrame: 1 year
measure: The number of CRC patients for whom a calculated familial CRC risk is correctly interpreted by clinicians
timeFrame: 1 year
measure: The number of CRC patients with whom a calculated familial CRC risk and/or follow up policy is communicated by clinicians
timeFrame: 1 year
measure: Patients' uptake of the follow up policy
timeFrame: 1 year
measure: Actual exposure to the different elements of the implementation strategy
timeFrame: 1 year
measure: Experiences of clinicians and patients with the different elements of the implementation strategy
timeFrame: 1 year
measure: Costs of the implementation procedure
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Radboud University Medical Center
name: Nicoline Hoogerbrugge, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Rosella PMG Hermens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.