The main aim of this study is to determine whether there is a difference in time to diagnosis of advanced colorectal neoplasms using quantitative Fecal Immunochemical Tests (FIT) to prioritize referral for colonoscopy (intervention) compared to usual care (qualitative FIT and appointment-based referral).
It is hypothesized that quantitative FIT will enable faster detection of advanced neoplasms compared to qualitative FIT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Enrollment
700
This test measures the amount of blood within the submitted stool specimen
This test detects presence or absence of blood within a submitted stool specimen.
Patients with positive tests will be subjected to colonoscopy to determine presence or absence of advanced colorectal neoplasms.
University of Malaya Medical Centre
Kuala Lumpur, Malaysia
Time to diagnosis of advanced colorectal neoplasms
Measured as number of days from the time of enrolment until histological diagnosis of a colorectal neoplasm
Time frame: 40-90 days from the time of enrolment
Analysis of screening costs
Total costs incurred as a result of the screening process
Time frame: Up to 90 days following enrolment
Patient anxiety levels
As measured by the Hospital Anxiety and Depression Scale (HADS)
Time frame: Up to 90 days after enrolment
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Data on direct and indirect costs to patient and institution will be collected at each patient visit related to screening.
Hospital Anxiety and Depression Scale (HADS) questionnaire
A 5-point patient satisfaction score will be documented at each patient visit related to screening.