NCT07852793

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40,000

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
49mo left

Started Oct 2026

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

5 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

October 30, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2029

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2030

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

3 years

First QC Date

September 21, 2026

Last Update Submit

September 28, 2026

Conditions

Colorectal Cancer

Keywords

Colorectal CancerCancer ScreeningFITInterventionsFollow-up Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • FIT completion.

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

    3 months.

Secondary Outcomes (4)

  • Follow-up Colonoscopy completion after positive FIT screening.

    6 months after positive FIT screening.

  • Diagnosis of CRC.

    6 months.

  • Stage of CRC at diagnosis.

    6 months.

  • Cancer-specific mortality.

    4 years.

Other Outcomes (1)

  • Cost-effectiveness of the screening programme.

    4 years post-randomization.

Study Arms (7)

Arm A: Usual Care

NO INTERVENTION

CRC screenings are recommended opportunistically by primary care providers during routine healthcare visits.

Arm B: SMS Reminders

ACTIVE COMPARATOR

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

Behavioral: SMS Reminders

Arm C: SMS Reminders + Mailed Reminder

ACTIVE COMPARATOR

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

Arm D: SMS Reminders + Mailed Reminder + Patient Navigation

ACTIVE COMPARATOR

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

Arm E: SMS Reminders + Mailed Return

ACTIVE COMPARATOR

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

Arm F: SMS Reminders + Mailed FIT

ACTIVE COMPARATOR

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

Arm G: SMS Reminders + Mailed FIT + Patient Navigation

ACTIVE COMPARATOR

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

Interventions

SMS RemindersBEHAVIORAL

5,000 patients will be allocated in this arm.

Arm B: SMS Reminders
SMS reminders + mailed reminderBEHAVIORAL

5,000 patients will be allocated in this arm.

Arm C: SMS Reminders + Mailed Reminder
SMS reminders + mailed reminder + patient navigationBEHAVIORAL

5,000 patients will be allocated in this arm.

Arm D: SMS Reminders + Mailed Reminder + Patient Navigation
SMS reminders + mailed returnBEHAVIORAL

5,000 patients will be allocated in this arm.

Arm E: SMS Reminders + Mailed Return
SMS reminders + mailed FITBEHAVIORAL

5,000 patients will be allocated in this arm.

Arm F: SMS Reminders + Mailed FIT
SMS reminders + mailed FIT + patient navigationBEHAVIORAL

5,000 patients will be allocated in this arm.

Arm G: SMS Reminders + Mailed FIT + Patient Navigation

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

SingHealth Polyclinic

Singapore, 150167, Singapore

Location

National Cancer Center, Singapore

Singapore, 168583, Singapore

Location

Changi General Hospital

Singapore, 529889, Singapore

Location

Sengkang General Hospital

Singapore, 544886, Singapore

Location

Singapore General Hospital

Singapore, Singapore

Location

Related Publications (20)

  • Ministry of Health S. National Population Health Survey (NPHS) 2024 Report. 2024.

    BACKGROUND

  • Robertson DJ, Lee JK, Boland CR, Dominitz JA, Giardiello FM, Johnson DA, Kaltenbach T, Lieberman D, Levin TR, Rex DK. Recommendations on Fecal Immunochemical Testing to Screen for Colorectal Neoplasia: A Consensus Statement by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2017 Apr;152(5):1217-1237.e3. doi: 10.1053/j.gastro.2016.08.053. Epub 2016 Oct 19.

    PMID: 27769517BACKGROUND

  • Fok RW, Lim SW, Letchimy D, Chiang J, Yuen J, Lim TQ, Chua ZY, Liong SZ, Yang GM, Tan NC, Lee ES, Ngeow J. Assessing the Feasibility and Acceptability of a Colorectal Cancer Risk Prediction Tool in Primary Care to Increase Screening Uptake in Singapore: A Multi-Methods Pilot Study. J Prim Care Community Health. 2025 Jan-Dec;16:21501319251397205. doi: 10.1177/21501319251397205. Epub 2025 Dec 11.

    PMID: 41382976BACKGROUND

  • Castells A, Quintero E, Bujanda L, Castan-Cameo S, Cubiella J, Diaz-Tasende J, Lanas A, Ono A, Serra-Burriel M, Frias-Arrocha E, Hernandez C, Jover R, Andreu M, Carballo F, Morillas JD, Salas D, Almazan R, Alonso-Abreu I, Banales JM, Hernandez V, Portillo I, Vanaclocha-Espi M, de la Vega M; COLONPREV study investigators. Effect of invitation to colonoscopy versus faecal immunochemical test screening on colorectal cancer mortality (COLONPREV): a pragmatic, randomised, controlled, non-inferiority trial. Lancet. 2025 Apr 12;405(10486):1231-1239. doi: 10.1016/S0140-6736(25)00145-X. Epub 2025 Mar 27.

    PMID: 40158525BACKGROUND

  • Quintero E, Castells A, Bujanda L, Cubiella J, Salas D, Lanas A, Andreu M, Carballo F, Morillas JD, Hernandez C, Jover R, Montalvo I, Arenas J, Laredo E, Hernandez V, Iglesias F, Cid E, Zubizarreta R, Sala T, Ponce M, Andres M, Teruel G, Peris A, Roncales MP, Polo-Tomas M, Bessa X, Ferrer-Armengou O, Grau J, Serradesanferm A, Ono A, Cruzado J, Perez-Riquelme F, Alonso-Abreu I, de la Vega-Prieto M, Reyes-Melian JM, Cacho G, Diaz-Tasende J, Herreros-de-Tejada A, Poves C, Santander C, Gonzalez-Navarro A; COLONPREV Study Investigators. Colonoscopy versus fecal immunochemical testing in colorectal-cancer screening. N Engl J Med. 2012 Feb 23;366(8):697-706. doi: 10.1056/NEJMoa1108895.

    PMID: 22356323BACKGROUND

  • Zauber AG. The impact of screening on colorectal cancer mortality and incidence: has it really made a difference? Dig Dis Sci. 2015 Mar;60(3):681-91. doi: 10.1007/s10620-015-3600-5. Epub 2015 Mar 5.

    PMID: 25740556BACKGROUND

  • Scott RE, Chang P, Kluz N, Baykal-Caglar E, Agrawal D, Pignone M. Equitable Implementation of Mailed Stool Test-Based Colorectal Cancer Screening and Patient Navigation in a Safety Net Health System. J Gen Intern Med. 2023 May;38(7):1631-1637. doi: 10.1007/s11606-022-07952-0. Epub 2022 Dec 1.

    PMID: 36456842BACKGROUND

  • Coronado GD, Petrik AF, Vollmer WM, Taplin SH, Keast EM, Fields S, Green BB. Effectiveness of a Mailed Colorectal Cancer Screening Outreach Program in Community Health Clinics: The STOP CRC Cluster Randomized Clinical Trial. JAMA Intern Med. 2018 Sep 1;178(9):1174-1181. doi: 10.1001/jamainternmed.2018.3629.

    PMID: 30083752BACKGROUND

  • Gupta S, Halm EA, Rockey DC, Hammons M, Koch M, Carter E, Valdez L, Tong L, Ahn C, Kashner M, Argenbright K, Tiro J, Geng Z, Pruitt S, Skinner CS. Comparative effectiveness of fecal immunochemical test outreach, colonoscopy outreach, and usual care for boosting colorectal cancer screening among the underserved: a randomized clinical trial. JAMA Intern Med. 2013 Oct 14;173(18):1725-32. doi: 10.1001/jamainternmed.2013.9294.

    PMID: 23921906BACKGROUND

  • Ramai D, Pan CW, Rodriguez B, Amdetsion G, Qatomah A, Beran A, Wang Y, Shaukat A, Oxentenko A, Rex DK, Fang J, Inadomi JM. Interventions for Increasing Colorectal Cancer Screening Uptake: A Systematic Review and Network Meta-Analysis. Gastroenterology. 2026 Sep;171(3):537-549. doi: 10.1053/j.gastro.2026.02.047. Epub 2026 Apr 1.

    PMID: 41932450BACKGROUND

  • Korostoff-Larsson O, King WC, Pelegri E, Colella D, Dapkins I, Eng K, Klapheke N, Krelle H, Mahieu N, McManus E, Shahin G, Woodriff M, Horwitz LI, Elmaleh-Sachs A. Behaviorally Informed Text Messaging to Promote Colon Cancer Screening: A Quality Improvement Randomized Clinical Trial. JAMA Netw Open. 2026 Apr 1;9(4):e267122. doi: 10.1001/jamanetworkopen.2026.7122.

    PMID: 42024386BACKGROUND

  • Robb KA, Young B, Murphy MK, Duklas P, McConnachie A, Hollands GJ, McCowan C, Macdonald S, O'Carroll RE, O'Connor RC, Steele RJC. Behavioural interventions to increase uptake of FIT colorectal screening in Scotland (TEMPO): a nationwide, eight-arm, factorial, randomised controlled trial. Lancet. 2025 Mar 29;405(10484):1081-1092. doi: 10.1016/S0140-6736(24)02813-7. Epub 2025 Mar 12.

    PMID: 40088914BACKGROUND

  • Heyman H, Saraste D, Jonsson H, Blom J. Colorectal Cancer Risk With Negative Colonoscopy or Nonadherence After Positive FOBT Screening. JAMA Netw Open. 2026 Mar 2;9(3):e262404. doi: 10.1001/jamanetworkopen.2026.2404.

    PMID: 41854612BACKGROUND

  • Zhu Y, Li X, Hu Y, Chen K, Zheng S, Ding K; Colorectal Cancer Screening Cohort Research Group. Nonadherence to Referral Colonoscopy After Positive Fecal Immunochemical Test Results Increases the Risk of Distal Colorectal Cancer Mortality. Gastroenterology. 2023 Dec;165(6):1558-1560.e4. doi: 10.1053/j.gastro.2023.08.013. Epub 2023 Aug 19. No abstract available.

    PMID: 37598799BACKGROUND

  • Choi KS, Lee HY, Jun JK, Shin A, Park EC. Adherence to follow-up after a positive fecal occult blood test in an organized colorectal cancer screening program in Korea, 2004-2008. J Gastroenterol Hepatol. 2012 Jun;27(6):1070-7. doi: 10.1111/j.1440-1746.2011.06944.x.

    PMID: 22004224BACKGROUND

  • Alsayid M, Singh MH, Issaka R, Laleau V, Day L, Lee J, Allison J, Somsouk M. Yield of Colonoscopy After a Positive Result From a Fecal Immunochemical Test OC-Light. Clin Gastroenterol Hepatol. 2018 Oct;16(10):1593-1597.e1. doi: 10.1016/j.cgh.2018.04.014. Epub 2018 Apr 13.

    PMID: 29660528BACKGROUND

  • Green BB, Baldwin LM, West II, Schwartz M, Coronado GD. Low Rates of Colonoscopy Follow-up After a Positive Fecal Immunochemical Test in a Medicaid Health Plan Delivered Mailed Colorectal Cancer Screening Program. J Prim Care Community Health. 2020 Jan-Dec;11:2150132720958525. doi: 10.1177/2150132720958525.

    PMID: 32912056BACKGROUND

  • Mohl JT, Ciemins EL, Miller-Wilson LA, Gillen A, Luo R, Colangelo F. Rates of Follow-up Colonoscopy After a Positive Stool-Based Screening Test Result for Colorectal Cancer Among Health Care Organizations in the US, 2017-2020. JAMA Netw Open. 2023 Jan 3;6(1):e2251384. doi: 10.1001/jamanetworkopen.2022.51384.

    PMID: 36652246BACKGROUND

  • Hang D, Zhu C, Yang X, He J, Li H, Pan T, Wang L, Wang S, Wu W, Zhong J, Gong W, Zhu M, Song C, Ma H, Li N, Qiu Y, Jin G, Hu Z, Du L, Cheng X, Shen H. Colorectal Cancer Screening Based on Fecal Immunochemical Test and Risk Assessment: A Population-based Study Including Two Million Participants in China. J Epidemiol. 2025 Jun 5;35(6):297-302. doi: 10.2188/jea.JE20240252. Epub 2025 Apr 30.

    PMID: 39647912BACKGROUND

  • Chua WY, Chew L, Chan CKM, et al. Evaluation of Intervention Strategies to Improve Follow-up Colonoscopy After Abnormal FIT/FOBT: A Systematic Review and Meta-analysis. SSRN (Preprint). 2026;doi:10.2139/ssrn.6861511

    BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered CarePrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Dr Kennedy NG

    National Cancer Centre, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ms LEE Kit Yee

CONTACT

+65 6346 8000lee.kit.yee@singhealth.com.sg

Dr CHUA Wei Yu

CONTACT

chua.wei.yu@mohh.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Our seven-arm RCT will compare the effectiveness of different multi-modal interventions. Randomization will be conducted at the individual participant level in quarterly cohorts rather than through a continuous sequential process. A total of 40,000 eligible participants will be enrolled, with approximately 10,000 participants included in each quarterly cohort. Prior to study initiation, the study statisticians will prepare a computer-generated stratified block randomization schedule, stratified by polyclinic site and quarterly cohort, to ensure balanced allocation across sites and enrolment periods. After the participant list for a given quarter has been finalized and locked, all participants within that cohort will be randomized simultaneously according to the pre-generated randomization schedule. Participants will be allocated in a 2:1:1:1:1:1:1 ratio between the control arm (Usual Care) and each of the six intervention arms.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2026

First Posted

October 1, 2026

Study Start (Estimated)

October 30, 2026

Primary Completion (Estimated)

October 30, 2029

Study Completion (Estimated)

October 30, 2030

Last Updated

October 1, 2026

Record last verified: 2026-09

Locations

SG(5)