NCT02645084

Brief Summary

In this trial the investigators will evaluate the effectiveness of the implementation of a digital familial risk questionnaire in the detection of CRC patients with hereditary or familial CRC. This will be done using a stepped wedge design with 5 participating hospitals for a duration of 1.5 years. A comparison is made between an intervention phase (offering the online risk assessment questionnaire) and a control phase (hospital-based standard practice for the detection of CRC patients with hereditary or familial CRC, informed by the referral criteria that are being used in the intervention group). All patients with a diagnosis of CRC who have a first appointment at the CRC outpatient clinic will be included. The primary outcome is the percentage of all included patients who receive a recommendation for regular surveillance colonoscopies for himself/herself and/or relatives, provided by a clinical geneticist. Data from clinical geneticists is being used to answer this question.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Feb 2015

Status
completed

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

Study Start

First participant enrolled

February 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2016

Completed
Last Updated

July 5, 2017

Status Verified

July 1, 2017

Enrollment Period

1.2 years

First QC Date

December 29, 2015

Last Update Submit

July 3, 2017

Conditions

Colorectal CancerLynch SyndromeFamilial Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Percentage of all included patients who have received a recommendation for regular surveillance colonoscopies for himself/herself and/or relatives, provided by a clinical geneticist.

    After 1.5 years (study completion)

Secondary Outcomes (11)

  • Percentage of all included patients with a referral to a clinical geneticist

    After 1.5 years (study completion)

  • Percentage of referred patients fulfilling referral criteria for a Lynch syndrome suspicion

    After 1.5 years (study completion)

  • Percentage of all included patients with genetically confirmed Lynch syndrome

    After 1.5 years (study completion)

  • Percentage of all included patients with confirmed other hereditary CRC syndromes (such as polyposis syndromes)

    After 1.5 years (study completion)

  • Percentage of referred patients fulfilling FCC criteria

    After 1.5 years (study completion)

  • +6 more secondary outcomes

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Intervention: offering an online risk assessment questionnaire to CRC patients, to facilitate the detection of colorectal cancer patients with hereditary or familial colorectal cancer

Other: Offering an online risk assessment questionnaire

Control

NO INTERVENTION

Control: Hospital-based standard practice for the detection of colorectal cancer patients with hereditary or familial colorectal cancer, informed by the referral criteria that are being used in the intervention group

Interventions

Offering an online risk assessment questionnaireOTHER

Offering an online risk assessment questionnaire to CRC patients, to facilitate the detection of colorectal cancer patients with hereditary or familial colorectal cancer

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a diagnosis of CRC who have a first appointment at the outpatient clinic (before treatment has started). If a patient undergoes surgery before going to an outpatient clinic (in case of an acute surgery indication), this patient will not be included in our study

You may not qualify if:

  • Patients who have received a CRC treatment before their intake visit will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal NeoplasmsColorectal Neoplasms, Hereditary Nonpolyposis

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDNA Repair-Deficiency DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Evelien Dekker, MD PhD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

December 29, 2015

First Posted

January 1, 2016

Study Start

February 1, 2015

Primary Completion

April 1, 2016

Study Completion

October 30, 2016

Last Updated

July 5, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share