Evaluating the Effectiveness of Screening Strategies Using Quantitative Versus Qualitative Fecal Immunochemical Test (FIT) to Prioritize Urgency of Colonoscopy Referral - a Randomized Controlled Trial Protocol
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Malaya
- Enrollment
- 700
- Locations
- 1
- Primary Endpoint
- Time to diagnosis of advanced colorectal neoplasms
Study Overview
Brief Summary
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).
Detailed Description
It is hypothesized that quantitative FIT will enable faster detection of advanced neoplasms compared to qualitative FIT.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adults aged 50 years and above
Exclusion Criteria
- •Lower gastrointestinal tract symptoms such as diarrhoea, constipation, per rectal bleeding
- •Personal history of colorectal tumour or cancer
- •Family history of familial adenomatous polyposis or hereditary non-polyposis colorectal cancer
Arms & Interventions
Qualitative fecal immunochemical test
Stool samples will be tested with the qualitative fecal immunochemical test (qFIT), and will be stratified for colonoscopy as follows:
>200 ng/dL - colonoscopy with one month 100-200 ng/dL - colonoscopy as per waiting list <100 ng/dL - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
Intervention: Cost analysis (Other)
Qualitative fecal immunochemical test
Stool samples will be tested with the qualitative fecal immunochemical test (qFIT), and will be stratified for colonoscopy as follows:
>200 ng/dL - colonoscopy with one month 100-200 ng/dL - colonoscopy as per waiting list <100 ng/dL - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
Intervention: Qualitative fecal immunochemical test (Other)
Qualitative fecal immunochemical test
Stool samples will be tested with the qualitative fecal immunochemical test (qFIT), and will be stratified for colonoscopy as follows:
>200 ng/dL - colonoscopy with one month 100-200 ng/dL - colonoscopy as per waiting list <100 ng/dL - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
Intervention: Colonoscopy (Procedure)
Qualitative fecal immunochemical test
Stool samples will be tested with the qualitative fecal immunochemical test (qFIT), and will be stratified for colonoscopy as follows:
>200 ng/dL - colonoscopy with one month 100-200 ng/dL - colonoscopy as per waiting list <100 ng/dL - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
Intervention: Anxiety scores (Other)
Qualitative fecal immunochemical test
Stool samples will be tested with the qualitative fecal immunochemical test (qFIT), and will be stratified for colonoscopy as follows:
>200 ng/dL - colonoscopy with one month 100-200 ng/dL - colonoscopy as per waiting list <100 ng/dL - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
Intervention: Patient satisfaction scores (Other)
Quantitative fecal immunochemical test
Stool samples will be tested with the quantitative fecal immunochemical test (FIT), and will be scheduled for colonoscopy as follows:
Positive - colonoscopy as per waiting list Negative - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
Intervention: Anxiety scores (Other)
Quantitative fecal immunochemical test
Stool samples will be tested with the quantitative fecal immunochemical test (FIT), and will be scheduled for colonoscopy as follows:
Positive - colonoscopy as per waiting list Negative - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
Intervention: Quantitative fecal immunochemical test (Other)
Quantitative fecal immunochemical test
Stool samples will be tested with the quantitative fecal immunochemical test (FIT), and will be scheduled for colonoscopy as follows:
Positive - colonoscopy as per waiting list Negative - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
Intervention: Colonoscopy (Procedure)
Quantitative fecal immunochemical test
Stool samples will be tested with the quantitative fecal immunochemical test (FIT), and will be scheduled for colonoscopy as follows:
Positive - colonoscopy as per waiting list Negative - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
Intervention: Cost analysis (Other)
Quantitative fecal immunochemical test
Stool samples will be tested with the quantitative fecal immunochemical test (FIT), and will be scheduled for colonoscopy as follows:
Positive - colonoscopy as per waiting list Negative - no colonoscopy
Cost analysis, anxiety scores and patient satisfaction scores will be calculated for all patients.
Intervention: Patient satisfaction scores (Other)
Outcomes
Primary Outcomes
Time to diagnosis of advanced colorectal neoplasms
Time Frame: 40-90 days from the time of enrolment
Measured as number of days from the time of enrolment until histological diagnosis of a colorectal neoplasm
Secondary Outcomes
- Analysis of screening costs(Up to 90 days following enrolment)
- Patient anxiety levels(Up to 90 days after enrolment)