Clinical Trial: Identifying Patients With Hereditary and Familial Colorectal Cancer by Using an Online Risk Tool

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Identifying the Risk of Hereditary and Familial Colorectal Cancer in Colorectal Cancer Patients by Using an Online Risk Tool: An Evaluation Based on a Stepped Wedge Design

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.

Detailed Summary:

Design: This is a multicenter prospective comparative cohort study, using a stepped-wedge design. All clusters (hospitals) start with the control strategy and switch, one by one, to the intervention strategy. Every 9 weeks a hospital will start implementing the questionnaire after a short training period of 1 week. As a referral to a clinical geneticist can take up to several months, we allow at least 6 months for the collection of the results of the genetic tests.

Control strategy: Each hospital starts with the control strategy. Just before the start of this study, all hospitals will be sent a list with the clinical genetics referral criteria that will be used for this study. Each hospital can decide on how to use these criteria.

Intervention strategy: Before the start of the study, all hospitals will be informed when the use of the online questionnaire will be implemented. They will also receive a manual on how to use the online CRF and questionnaire. The online CRF will be used to send out invitations for the questionnaire, to report baseline characteristics (age, sex, nationality, educational level, native language), reasons for non-participation, the number of changes that need to be made when verifying completed questionnaires and to calculate referral advice. In the training week, a researcher from the AMC will present the study to all involved persons and he will facilitate the implementation of the online CRF and questionnaire. All nurses and doctors participating in this study will be provided with their own login codes for the online CRF. Patients included in the training week will not be included in the analysis. All consecutive patients with CRC that have a first appointment at the outpatient clinic will be invited to complete the online questionnaire and they receive a record number. In case patients decline
Sponsor: Prof. Evelien Dekker, MD, PhD

Current Primary Outcome: 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. [ Time Frame: After 1.5 years (study completion) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of all included patients with a referral to a clinical geneticist [ Time Frame: After 1.5 years (study completion) ]
  • Percentage of referred patients fulfilling referral criteria for a Lynch syndrome suspicion [ Time Frame: After 1.5 years (study completion) ]
  • Percentage of all included patients with genetically confirmed Lynch syndrome [ Time Frame: After 1.5 years (study completion) ]
  • Percentage of all included patients with confirmed other hereditary CRC syndromes (such as polyposis syndromes) [ Time Frame: After 1.5 years (study completion) ]
  • Percentage of referred patients fulfilling FCC criteria [ Time Frame: After 1.5 years (study completion) ]
  • Percentage of all included patients who receive a surveillance advice per time period (month or season) [ Time Frame: After 1.5 years (study completion) ]
  • Percentage of referred patients not fulfilling referral criteria for FCC, a Lynch syndrome suspicion or other hereditary CRC syndromes [ Time Frame: After 1.5 years (study completion) ]
  • Percentage of patients not adhering to referral advice [ Time Frame: After 1.5 years (study completion) ]
  • The number of changes in family history after verification of the completed questionnaire at the outpatient clinic [ Time Frame: After 1.5 years (study completion) ]
  • Patients' reasons for not filling out the questionnaire as reported by a nurse or gastroenterologist [ Time Frame: After 1.5 years (study completion) ]
  • Usability of the questionnaire for health care providers and patients by using a self-created online or paper questionnaire [ Time Frame: After 1.5 years (study completion) ]


Original Secondary Outcome: Same as current

Information By: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Dates:
Date Received: December 29, 2015
Date Started: February 2015
Date Completion: October 2016
Last Updated: January 3, 2016
Last Verified: January 2016