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A Trial of the Implementation of iFOBT in General Practice

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ClinicalTrials.gov Identifier: NCT02308384
Recruitment Status : Completed
First Posted : December 4, 2014
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Study Description
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Brief Summary:

Background

Colorectal cancer (CRC) is common, and a leading cause of cancer death. The evaluation of patients suspected to have CRC is difficult due to poorly predictive alarm symptoms and many patients present with uncharacteristic or vague symptoms. The faecal marker of human globin, iFOBT, could play an important role in aiding the general practitioner in detecting CRC.

Hypothesis

It will be possible to implement iFOBT in general practice as a test performed on patients who do not fulfill the criteria for fast-track referral for colorectal cancer, but whose symptoms could indicate an undiagnosed colorectal cancer.

Aim

To implement iFOBT in general practice and evaluate the uptake and clinical use of the test. Furthermore, we want to investigate the performance of iFOBT when used on patients presenting with uncharacteristic symptoms of CRC, and the clinical implications.

Materials and methods

The study uses a cluster randomised stepped wedge design. Clusters are constituted by the 18 municipalities in the central Denmark Region, and these are randomised when to receive a continuous medical education (CME). The date of inclusion is defined as the first working day in the month the CME is planned to be conducted. The CME is part of an intervention aimed to facilitate the implementation of iFOBT in general practice. Besides a CME, the intervention consist of a start package (iFOBT kits, a guideline and online educational material) that is sent to GPs when they are included in the study, and a status mail that GPs receive approx. one month after inclusion. The inclusion period is during the first 7 month of the study period, the study lasts for one year.

Perspectives

This study will provide important knowledge on how to improve CRC diagnostics in general practice.


Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Intervention Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 825 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Use of Immunochemical Faecal Occult Blood Test (iFOBT) in General Practice. A Randomised Trial of the Implementation of iFOBT.
Study Start Date : September 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Before intervention
GPs in this group have not yet received intervention.
Experimental: After intervention
GPs in this group have received the intervention.
 Behavioral: Intervention
CME, Start-package and status mail


Outcome Measures
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Primary Outcome Measures :
  1. The rate of positive iFOBTs [ Time Frame: 1 year ]
  2. The number of CRCs diagnosed after a positive iFOBT [ Time Frame: 1 year ]
  3. The stage distribution of CRCs for patients with a positive iFOBT [ Time Frame: 1 year ]
    UICC stages I-IV

  4. The positive predictive value for detecting colorectal cancer [ Time Frame: 1 year ]
    The risk of having CRC when the iFOBT is positive

  5. The positive predictive value for detecting colorectal cancer in relation to cut-off value of iFOBT [ Time Frame: 1 year ]
    The risk of having CRC at different iFOBT values.

  6. The positive predictive value for detecting colorectal cancer in relation to indications of using iFOBT [ Time Frame: 1 year ]
    The risk of having CRC when iFOBT is positive and specific symptoms. When requesting FIT, the GP register the patients' symptoms.


Secondary Outcome Measures :
  1. The rate of general practices starting to use the iFOBT, stratified for participation in the CME. [ Time Frame: 1 year ]
    The relation between number of general practices started using iFOBT and time.

  2. The monthly rate of requested iFOBTs, stratified for participation in the CME. [ Time Frame: 1 year ]
    The relation between number of requested iFOBTs and time.

  3. The monthly rate of positive iFOBTs, stratified for participation in the CME. [ Time Frame: 1 year ]
    The relation between number of positive iFOBTs and time.

  4. Indications used for requesting iFOBT, stratified for participation in the CME. [ Time Frame: 1 year ]
  5. The rate of referrals in the cancer patient pathway for colorectal cancer [ Time Frame: 1 year ]
  6. The rate of performed colonoscopies [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • GPs in the Central Denmark Region
  • Patients >30 years eligible for iFOBT according to guideline

Exclusion Criteria:

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02308384


Locations
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Denmark
Research Unit for General Practice
Aarhus C, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Study Director: Peter Vedsted, Professor Research Unit of General Practice, Odense
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02308384     History of Changes
Other Study ID Numbers: Randomiseret iFOBT studie
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: November 2015
Keywords provided by University of Aarhus:
iFOBT
FIT
general practice
early diagnosis
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases