Mailed FIT-Based Outreach Interventions

September 28, 2026 updated by: National Cancer Centre, Singapore

Mailed FIT-Based Outreach Interventions vs Usual Care to Increase Uptake of Colorectal Cancer Screening in a Multi-Ethnic Population: A 7-Arm Randomized Controlled 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

CRC is the second most common cancer and cause of cancer-related mortality in Singapore. However, completion of CRC screenings remains suboptimal, with only 44.9% of eligible adults aged 50-74 years in Singapore up to date with CRC screening, far below the recommended 80% CRC screening completion rate set by the US Multi-Society Task Force on CRC. Singapore currently adopts a risk-stratified model for CRC screening, in which asymptomatic individuals without a family history of CRC are regarded as average-risk and are recommended annual fecal immunochemical test (FIT) or 5 to 10 yearly colonoscopies from 50 years old. However, these are usually recommended opportunistically by primary care providers during a routine healthcare visit. Among average-risk individuals, patients are more likely to participate in stool-based testing (34%-39%) than colonoscopy (24%-31%).

While FIT screening is cost-effective for health systems while reducing CRC mortality, the substantial screening gap underscores the need for interventions to increase FIT uptake. Numerous studies in other settings have compared the effectiveness of interventions such as mailed FIT, patient reminders, and patient navigation in improving screening uptake. Among these, mailed FIT outreach has emerged as a particularly effective strategy, reducing logistical barriers and enabling wider population coverage. Gupta et al. found that CRC screening participation was significantly higher for patients with mailed FIT (40.7%) compared to usual care (12.1%). A meta-analysis of randomized controlled trials (RCTs) by Ramal et al. found that patient navigation (RR, 1.58; 95% CI, 1.23-2.02) outperformed usual care in increasing CRC screening uptake. Meanwhile, a recent trial by Korostoff-Larsson et al. found that SMS reminders were associated with significantly improved FIT completion compared with usual telephone call reminders (58.9% vs 49.8%). The TEMPO trial by Robb et al. found that setting a 2-week deadline increased the FIT return rate compared with control (68.0% vs 63.2%). However, most of these studies compared single outreach interventions against usual care alone, leaving limited evidence on cost-effectiveness and on whether combining interventions produces synergistic, additive, or antagonistic effects. Therefore, it is important to assess the most effective and efficient strategy in the local context.

A successful FIT programme requires adherence to follow-up colonoscopy after an abnormal result. Large studies using data from community or national screening programs have shown colonoscopy completion rates of only 32%-56% within 1 year of an abnormal FIT/FOBT, and non-adherence to follow-up colonoscopy is associated with higher CRC incidence and mortality. A meta-analysis of 21 studies by our study team identified four interventions that increased completion of follow-up colonoscopy after an abnormal FIT: patient navigation (RR 1.24), patient reminders (RR 1.32), provider reminders (RR 1.36), and automated referral to gastrointestinal (GI) consult (RR 1.68).

Therefore, this study aims to identify the most effective and cost-effective strategy for increasing CRC screening participation and adherence within Singapore's public healthcare system. Specific objectives are to:

  1. evaluate the effectiveness of mailed FIT outreach, reminders, patient navigation, and behavioural interventions in increasing initial FIT completion, sustained annual FIT adherence across three screening rounds, and reducing screening disparities;
  2. assess the effectiveness of an evidence-based programme incorporating patient reminders, patient navigation, provider reminders, and automated gastroenterology referrals in increasing follow-up colonoscopy completion after abnormal FIT results;
  3. evaluate whether improved screening participation and diagnostic follow-up increase the detection of early-stage CRC; and
  4. evaluate the cost-effectiveness of competing intervention strategies from the healthcare system perspective.

This is a 3-year longitudinal screening trial consisting of 3 annual rounds of screening. Participants enrolled in Round 1 (Year 1) are intended to be followed for subsequent annual screenings (Year 2 and Year 3). Research funding and institutional approval are secured for Round 1; Rounds 2 and 3 are pending final funding approval.

Study Type

Interventional

Enrollment (Estimated)

40000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Singapore
      • Singapore, Singapore
        • Singapore General Hospital
        • Contact:
          • Prof Emile John TAN Kwong Wei, MBBS, FRCS
      • Singapore, Singapore, 529889
        • Changi General Hospital
        • Contact:
          • A/Prof Andrew KWEK Boon Eu, MBBS, MRCP
      • Singapore, Singapore, 544886
        • Sengkang General Hospital
        • Contact:
          • Dr Clarence KWAN Kah Wai, MBBS, MRCP
      • Singapore, Singapore, 168583
        • National Cancer Center, Singapore
        • Contact:
          • Dr Kennedy NG, MBBS (Hons), MRCP, MPA
      • Singapore, Singapore, 150167
        • SingHealth Polyclinic
        • Contact:
          • Dr KOH Kim Hwee, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Prior diagnosis of CRC, advanced cancer, or palliative care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Arm A: Usual Care

CRC screenings are recommended opportunistically by primary care providers during routine healthcare visits.
Active Comparator: Arm B: SMS Reminders

Three SMS reminders spaced one week apart will be sent to the patient on top of usual care.
Behavioral: SMS Reminders

5,000 patients will be allocated in this arm.
Active Comparator: Arm C: SMS Reminders + Mailed Reminder

Three SMS reminders spaced one week apart will be sent to the patient on top of usual care. A mailed reminder will be sent to participants by the 4th week from Day 0.
Behavioral: SMS reminders + mailed reminder

5,000 patients will be allocated in this arm.
Active Comparator: Arm D: SMS Reminders + Mailed Reminder + Patient Navigation

Three SMS reminders spaced one week apart will be sent to the patient on top of usual care. A mailed reminder will be sent to participants by the 4th week from Day 0. Patient navigation/Follow-up phone call by staff if the FIT kit is not returned by the end of 6th week from Day 0.
Behavioral: SMS reminders + mailed reminder + patient navigation

5,000 patients will be allocated in this arm.
Active Comparator: Arm E: SMS Reminders + Mailed Return

Three SMS reminders spaced one week apart will be sent to the patient on top of usual care. Participants will be given an option to return the clinic-distributed FIT kits via mail.
Behavioral: SMS reminders + mailed return

5,000 patients will be allocated in this arm.
Active Comparator: Arm F: SMS Reminders + Mailed FIT

A FIT kit will be mailed to the participant's address at the start of the study, accompanied by outreach materials. Three SMS reminders spaced one week apart will be sent to the patient on top of usual care.
Behavioral: SMS reminders + mailed FIT

5,000 patients will be allocated in this arm.
Active Comparator: Arm G: SMS Reminders + Mailed FIT + Patient Navigation

A FIT kit will be mailed to the participant's address at the start of the study, accompanied by outreach materials. Three SMS reminders spaced one week apart will be sent to the patient on top of usual care. Patient navigation/Follow-up phone call by staff if the FIT kit is not returned by the end of 6th week from Day 0.
Behavioral: SMS reminders + mailed FIT + patient navigation

5,000 patients will be allocated in this arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FIT completion.
Time Frame: 3 months.

By the end of 3 months, FIT completion rates will be analyzed as either completed or not completed.
3 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follow-up Colonoscopy completion after positive FIT screening.
Time Frame: 6 months 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.
6 months after positive FIT screening.
Diagnosis of CRC.
Time Frame: 6 months.

Diagnosis of CRC will be ascertained by histology obtained from colonoscopy. Diagnosis of CRC will be analyzed as either positive for CRC or normal.
6 months.
Stage of CRC at diagnosis.
Time Frame: 6 months.

Our study will collect the stage of CRC at diagnosis. Staging will be determined by the AJCC 8th Edition TNM Staging System for CRC.
6 months.
Cancer-specific mortality.
Time Frame: 4 years.

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.
4 years.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness of the screening programme.
Time Frame: 4 years post-randomization.

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.
4 years post-randomization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Centre, Singapore

Collaborators

Singapore General Hospital
Changi General Hospital
Sengkang General Hospital
SingHealth Polyclinic

Investigators

  • Principal Investigator: Dr Kennedy NG, National Cancer Centre, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 30, 2026

Primary Completion (Estimated)

October 30, 2029

Study Completion (Estimated)

October 30, 2030

Study Registration Dates

First Submitted

September 21, 2026

First Submitted That Met QC Criteria

September 28, 2026

First Posted (Actual)

October 1, 2026

Study Record Updates

Last Update Posted (Actual)

October 1, 2026

Last Update Submitted That Met QC Criteria

September 28, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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