NCT00929097

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 26, 2009

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

June 26, 2009

Status Verified

June 1, 2009

Enrollment Period

1.7 years

First QC Date

June 25, 2009

Last Update Submit

June 25, 2009

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis

Keywords

Colorectal Neoplasms, (Hereditary Nonpolyposis)GuidelineHealth Plan ImplementationDecision Support TechniquesRisk assessmentFamilial colorectal cancer riskRisk assessment tool

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (8)

  • The number of patients for whom MSI testing was performed based on the MIPA criteria

    1 year

  • 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 clinicians

    1 year

  • The number of CRC patients with whom a calculated familial CRC risk and/or follow up policy is communicated by clinicians

    1 year

  • Patients' uptake of the follow up policy

    1 year

  • +3 more secondary outcomes

Study Arms (2)

Implementation aids

EXPERIMENTAL
Other: Implementation aids

Control

ACTIVE COMPARATOR
Other: Control

Interventions

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

Implementation aids
ControlOTHER

Dissemination of guidelines

Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of colorectal cancer before the age of 70
  • Diagnosed in one of the participating hospitals
  • Able to read and understand Dutch

You may not qualify if:

  • Previous referral for genetic counseling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 23451840DERIVED

  • 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.

    PMID: 20181032DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsNeoplastic Syndromes, HereditaryDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Nicoline Hoogerbrugge, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • Rosella PMG Hermens, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 25, 2009

First Posted

June 26, 2009

Study Start

October 1, 2009

Primary Completion

July 1, 2011

Study Completion

January 1, 2012

Last Updated

June 26, 2009

Record last verified: 2009-06