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

Primary Purpose

Colorectal Neoplasms, Hereditary Nonpolyposis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Implementation aids
Control
Sponsored by
ZonMw: The Netherlands Organisation for Health Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Neoplasms, Hereditary Nonpolyposis focused on measuring Colorectal Neoplasms, (Hereditary Nonpolyposis), Guideline, Health Plan Implementation, Decision Support Techniques, Risk assessment, Familial colorectal cancer risk, Risk assessment tool

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Implementation aids

    Control

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    The number of patients for whom MSI testing was performed based on the MIPA criteria
    The number of CRC patients for whom a correct familial CRC risk is calculated by clinicians (as compared to formally calculated risks)
    The number of CRC patients for whom a calculated familial CRC risk is correctly interpreted by clinicians
    The number of CRC patients with whom a calculated familial CRC risk and/or follow up policy is communicated by clinicians
    Patients' uptake of the follow up policy
    Actual exposure to the different elements of the implementation strategy
    Experiences of clinicians and patients with the different elements of the implementation strategy
    Costs of the implementation procedure

    Full Information

    First Posted
    June 25, 2009
    Last Updated
    June 25, 2009
    Sponsor
    ZonMw: The Netherlands Organisation for Health Research and Development
    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
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00929097
    Brief Title
    Implementation of Guidelines on Hereditary or Familial Colorectal Cancer
    Acronym
    RISCO
    Official Title
    Implementation of Guidelines on Hereditary or Familial Colorectal Cancer Risk Calculation and Risk Communication
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2009 (undefined)
    Primary Completion Date
    July 2011 (Anticipated)
    Study Completion Date
    January 2012 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    ZonMw: The Netherlands Organisation for Health Research and Development
    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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Implementation aids
    Arm Type
    Experimental
    Arm Title
    Control
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    Implementation aids
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Control
    Intervention Description
    Dissemination of guidelines
    Primary Outcome Measure Information:
    Title
    The number of colorectal cancer patients following the most optimal follow up program according to the guidelines.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    The number of patients for whom MSI testing was performed based on the MIPA criteria
    Time Frame
    1 year
    Title
    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
    Title
    The number of CRC patients for whom a calculated familial CRC risk is correctly interpreted by clinicians
    Time Frame
    1 year
    Title
    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
    Title
    Patients' uptake of the follow up policy
    Time Frame
    1 year
    Title
    Actual exposure to the different elements of the implementation strategy
    Time Frame
    1 year
    Title
    Experiences of clinicians and patients with the different elements of the implementation strategy
    Time Frame
    1 year
    Title
    Costs of the implementation procedure
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nicoline Hoogerbrugge, MD, PhD
    Organizational Affiliation
    Radboud University Medical Center
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Rosella PMG Hermens, PhD
    Organizational Affiliation
    Radboud University Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23451840
    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.
    Results Reference
    derived
    PubMed Identifier
    20181032
    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.
    Results Reference
    derived

    Learn more about this trial

    Implementation of Guidelines on Hereditary or Familial Colorectal Cancer

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