Colorectal Neoplasms, Hereditary NonpolyposisRISCONCT00929097
Implementation of Guidelines on Hereditary or Familial Colorectal Cancer
A study testing Implementation aids in people with Colorectal Neoplasms, Hereditary Nonpolyposis, run by ZonMw: The Netherlands Organisation for Health Research and Development.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Neoplasms, Hereditary Nonpolyposis
- What is being tested?
- Implementation aids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of colorectal cancer before the age of 70
- Diagnosed in one of the participating hospitals
- Able to read and understand Dutch
Who cannot join
- Previous referral for genetic counseling
About this study
Official title: 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.
Read the 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.
- Being tested
- Implementation aids, Control
- Keywords
- Colorectal Neoplasms, (Hereditary Nonpolyposis), Guideline, Health Plan Implementation, Decision Support Techniques, Risk assessment, Familial colorectal cancer risk, Risk assessment tool
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation aidsOther
- 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
ControlOther
Dissemination of guidelines
| Study group | Role | What they receive |
|---|---|---|
| Implementation aids | Experimental | Not described Receives: Other: Implementation aids |
| Control | Active comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of colorectal cancer patients following the most optimal follow up program according to the guidelines.
Measured: 1 year
Secondary outcomes (8)
The number of patients for whom MSI testing was performed based on the MIPA criteria
Measured: 1 year
The number of CRC patients for whom a correct familial CRC risk is calculated by clinicians (as compared to formally calculated risks)
Measured: 1 year
The number of CRC patients for whom a calculated familial CRC risk is correctly interpreted by clinicians
Measured: 1 year
The number of CRC patients with whom a calculated familial CRC risk and/or follow up policy is communicated by clinicians
Measured: 1 year
Patients' uptake of the follow up policy
Measured: 1 year
Actual exposure to the different elements of the implementation strategy
Measured: 1 year
Experiences of clinicians and patients with the different elements of the implementation strategy
Measured: 1 year
Costs of the implementation procedure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2011 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal Neoplasms, Hereditary NonpolyposisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZonMw: The Netherlands Organisation for Health Research and Development
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Nicoline Hoogerbrugge, MD, PhD, Principal investigator, Radboud University Medical CenterRosella PMG Hermens, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929097
- Sponsor's protocol ID
- ZonMw 80-82315-98-09005
- Acronym
- RISCO
- Status last verified
- Jun 2009
- First submitted
- 25 Jun 2009
- Last updated
- 26 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 23451840Dekker 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.
PubMed 20181032
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Guidelines on Hereditary or Familial Colorectal Cancer Risk Calculation and Risk Communication
- ClinicalTrials.gov ID
- NCT00929097
- Acronym / sponsor ID
- RISCO / ZonMw 80-82315-98-09005
- Keywords
- Colorectal Neoplasms, (Hereditary Nonpolyposis), Guideline, Health Plan Implementation, Decision Support Techniques, Risk assessment, Familial colorectal cancer risk, Risk assessment tool
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- ZonMw: The Netherlands Organisation for Health Research and DevelopmentUniversity, hospital or other
- Collaborators
- Cardiff University, Erasmus Medical Center, Leiden University Medical Center, University Medical Center Groningen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Comprehensive Cancer Centres
- Study start
- Oct 2009
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 26 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Implementation aids | Experimental | Other: Implementation aids |
| Control | Active comparator | Other: Control |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of colorectal cancer before the age of 70
- Diagnosed in one of the participating hospitals
- Able to read and understand Dutch
Key exclusion criteria (1 listed)
- Previous referral for genetic counseling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Implementation aids |
| ControlDissemination of guidelines | Other | Control |
Primary outcome
The number of colorectal cancer patients following the most optimal follow up program according to the guidelines.
Time frame: 1 year
8 secondary outcomes
The number of patients for whom MSI testing was performed based on the MIPA criteria
Time frame: 1 year
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
The number of CRC patients for whom a calculated familial CRC risk is correctly interpreted by clinicians
Time frame: 1 year
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
Patients' uptake of the follow up policy
Time frame: 1 year
Actual exposure to the different elements of the implementation strategy
Time frame: 1 year
Experiences of clinicians and patients with the different elements of the implementation strategy
Time frame: 1 year
Costs of the implementation procedure
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2009.
- Derived from this study: PubMed 23451840Dekker 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.
- Derived from this study: PubMed 20181032Dekker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicoline Hoogerbrugge, MD, PhD principal investigator
Radboud University Medical Center
Rosella PMG Hermens, PhD principal investigator
Radboud University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Implementation aids in people with Colorectal Neoplasms, Hereditary Nonpolyposis, run by ZonMw: The Netherlands Organisation for Health Research and Development.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of colorectal cancer patients following the most optimal follow up program according to the guidelines. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00929097, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2009.