Mailed FIT-Based Outreach Interventions
ConditionColorectal Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorNational Cancer Centre, Singapore
About this trial
Colorectal cancer (CRC) is the second most common cancer and the second leading cause of cancer-related mortality in Singapore. Although annual fecal immunochemical testing (FIT) and periodic colonoscopy are recommended for average-risk adults aged 50-75, only 44.9% of eligible individuals are up to date with CRC screening. Screening participation, adherence to repeat annual FIT, and completion of diagnostic colonoscopy after abnormal FIT results remain suboptimal. This study aims to identify the most effective and cost-effective strategy for increasing CRC screening participation and adherence.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Eligible individuals are those enrolled with SingHealth Polyclinics aged 50-80 at time of study initiation, who are due for CRC screening (i.e., no FIT within the past year, or no colonoscopy within the past 5-10 years)
Disqualifiers
Prior diagnosis of CRC, advanced cancer, or palliative care
Trial design
Design model
Parallel
Treatments tested in this trial
SMS Reminders
Behavioral5,000 patients will be allocated in this arm.
SMS reminders + mailed reminder
Behavioral5,000 patients will be allocated in this arm.
SMS reminders + mailed reminder + patient navigation
Behavioral5,000 patients will be allocated in this arm.
SMS reminders + mailed return
Behavioral5,000 patients will be allocated in this arm.
SMS reminders + mailed FIT
Behavioral5,000 patients will be allocated in this arm.
SMS reminders + mailed FIT + patient navigation
Behavioral5,000 patients will be allocated in this arm.
Treatment groups
40,000 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: Arm A: Usual CareNo intervention 0 interventions
Group B: Arm B: SMS RemindersActive comparator 1 intervention
Group C: Arm C: SMS Reminders + Mailed ReminderActive comparator 1 intervention
Group D: Arm D: SMS Reminders + Mailed Reminder + Patient NavigationActive comparator 1 intervention
Group E: Arm E: SMS Reminders + Mailed ReturnActive comparator 1 intervention
Group F: Arm F: SMS Reminders + Mailed FITActive comparator 1 intervention
Group G: Arm G: SMS Reminders + Mailed FIT + Patient NavigationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
FIT completion.
By the end of 3 months, FIT completion rates will be analyzed as either completed or not completed.
Time frame
3 months.Secondary outcomes
1
Follow-up Colonoscopy completion after positive FIT screening.
By the end of 6 months after positive FIT, follow-up Colonoscopy rates will be analyzed as either completed or not completed.
Time frame
6 months after positive FIT screening.2
Diagnosis of CRC.
Diagnosis of CRC will be ascertained by histology obtained from colonoscopy. Diagnosis of CRC will be analyzed as either positive for CRC or normal.
Time frame
6 months.3
Stage of CRC at diagnosis.
Our study will collect the stage of CRC at diagnosis. Staging will be determined by the AJCC 8th Edition TNM Staging System for CRC.
Time frame
6 months.4
Cancer-specific mortality.
Our study will collect data on cancer-specific mortality till end of study duration. Patients with cancer-related causes of mortality will be analyzed as cancer-specific mortality.
Time frame
4 years.Other outcomes
1
Cost-effectiveness of the screening programme.
Combination of costs incurred from intervention delivery, implementation, navigation, and downstream healthcare costs. Cost-effectiveness analysis will be conducted using a Markov modelling approach, with health states corresponding to different stages of disease including disease-free, different stages of CRC, remission, and death.
Time frame
4 years post-randomization.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National Cancer Centre, Singapore
Lead sponsor
Sengkang General Hospital
Collaborator
Changi General Hospital
Collaborator
Singapore General Hospital
Collaborator
SingHealth Polyclinic
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: