The Use of Immunochemical Faecal Occult Blood Test (iFOBT) in General Practice. A Randomised Trial of the Implementation of iFOBT.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Aarhus
- Enrollment
- 825
- Locations
- 2
- Primary Endpoint
- The rate of positive iFOBTs
Study Overview
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.
Detailed Description
Background
Colorectal cancer (CRC) is the second most common type of cancer in Denmark and is a leading cause of cancer death. Since 2000, the incidence has been increasing by 1-1.5% each year. The estimated 5-year survival rate is currently 80% for stage I cancer, 50% for stages II and III, and <5 % for stage IV cancer. These figures emphasize the importance of detecting the disease in early stages and underline the current challenge of diagnosing CRC in general practice.
In 2008, a national fast-track system for cancer patients was established to ensure fast diagnosis and initiation of treatment. The fast-track system implies that patients presenting 'alarm' symptoms of e.g. CRC will be referred immediately for diagnostic workup; no more than 14 days must pass from referral to initiation of treatment. Several studies have shown that the positive predictive values (PPV) of the symptoms regarding CRC are fairly low (4-8%). In addition, approximately 50% of new CRC incidents will present with other vague and uncharacteristic symptoms than alarm symptoms.
In addition, a screening programme for CRC has been implemented. It is suggested that this will increase survival rate of CRC, however, it is estimated that approximately 75% of yearly CRC still have to be diagnosed through general practice.
A huge load is, consequently, still placed on general practice in the quest for earlier diagnosis of CRC, and better methods to aid the general practitioner in the diagnostic process are needed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •GPs in the Central Denmark Region
- •Patients >30 years eligible for iFOBT according to guideline
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
The rate of positive iFOBTs
Time Frame: 1 year
The number of CRCs diagnosed after a positive iFOBT
Time Frame: 1 year
The stage distribution of CRCs for patients with a positive iFOBT
Time Frame: 1 year
UICC stages I-IV
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.
The positive predictive value for detecting colorectal cancer
Time Frame: 1 year
The risk of having CRC when the iFOBT is positive
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.
Secondary Outcomes
- The rate of referrals in the cancer patient pathway for colorectal cancer(1 year)
- The monthly rate of positive iFOBTs, stratified for participation in the CME.(1 year)
- Indications used for requesting iFOBT, stratified for participation in the CME.(1 year)
- The rate of general practices starting to use the iFOBT, stratified for participation in the CME.(1 year)
- The rate of performed colonoscopies(1 year)
- The monthly rate of requested iFOBTs, stratified for participation in the CME.(1 year)