Colorectal CancerNCT07852793
Mailed FIT-Based Outreach Interventions
A study testing SMS Reminders, SMS reminders + mailed reminder and SMS reminders + mailed reminder + patient navigation in people with Colorectal Cancer, run by National Cancer Centre, Singapore at 5 sites in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- SMS Reminders, SMS reminders + mailed reminder and SMS reminders + mailed reminder + patient navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40,000 participants
- Where
- 5 sitesSingapore
- Study dates
- 30 Oct 2026to 30 Oct 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Prior diagnosis of CRC, advanced cancer, or palliative care
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Dr CHUA Wei Yu contact
5 sites in 1 country
Singapore5 sites
SingHealth Polyclinic
Singapore, 150167
Dr KOH Kim Hwee, MBBS
National Cancer Center, Singapore
Singapore, 168583
Dr Kennedy NG, MBBS (Hons), MRCP, MPA
Changi General Hospital
Singapore, 529889
A/Prof Andrew KWEK Boon Eu, MBBS, MRCP
Sengkang General Hospital
Singapore, 544886
Dr Clarence KWAN Kah Wai, MBBS, MRCP
Singapore General Hospital
Singapore
Prof Emile John TAN Kwong Wei, MBBS, FRCS
About this study
Official title: 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.
Read the 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:
- 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;
- 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;
- evaluate whether improved screening participation and diagnostic follow-up increase the detection of early-stage CRC; and
- 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.
- Conditions
- Colorectal Cancer
- Being tested
- SMS Reminders, SMS reminders + mailed reminder, SMS reminders + mailed reminder + patient navigation, SMS reminders + mailed return, SMS reminders + mailed FIT
- Keywords
- Colorectal Cancer, Cancer Screening, FIT, Interventions, Follow-up Colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS RemindersBehavioural
5,000 patients will be allocated in this arm.
SMS reminders + mailed reminderBehavioural
5,000 patients will be allocated in this arm.
SMS reminders + mailed reminder + patient navigationBehavioural
5,000 patients will be allocated in this arm.
SMS reminders + mailed returnBehavioural
5,000 patients will be allocated in this arm.
SMS reminders + mailed FITBehavioural
5,000 patients will be allocated in this arm.
SMS reminders + mailed FIT + patient navigationBehavioural
5,000 patients will be allocated in this arm.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: SMS reminders + mailed FIT + patient navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
FIT completion.
By the end of 3 months, FIT completion rates will be analyzed as either completed or not completed.
Measured: 3 months.
Secondary outcomes (4)
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.
Measured: 6 months after positive FIT screening.
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.
Measured: 6 months.
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.
Measured: 6 months.
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.
Measured: 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 Oct 2029 (estimated)
- Study completion30 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Sengkang General Hospital, Changi General Hospital, Singapore General Hospital, SingHealth Polyclinic
- Responsible party
- Sponsor
- Investigators
- Dr Kennedy NG, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852793
- Sponsor's protocol ID
- CRC-001
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ministry of Health S. National Population Health Survey (NPHS) 2024 Report. 2024.
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.
PubMed 27769517Fok 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.
PubMed 41382976Castells 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.
PubMed 40158525Quintero 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.
PubMed 22356323Zauber 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.
PubMed 25740556Scott 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.
PubMed 36456842Coronado 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.
PubMed 30083752Gupta 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.
PubMed 23921906Ramai 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.
PubMed 41932450Korostoff-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.
PubMed 42024386Robb 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.
PubMed 40088914Heyman 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.
PubMed 41854612Zhu 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.
PubMed 37598799Choi 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.
PubMed 22004224
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07852793
- Acronym / sponsor ID
- CRC-001
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, Cancer Screening, FIT, Interventions, Follow-up Colonoscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40,000 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- Sengkang General Hospital, Changi General Hospital, Singapore General Hospital, SingHealth Polyclinic
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 Oct 2029 (estimated)
- Study completion
- 30 Oct 2030 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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;
- 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;
- evaluate whether improved screening participation and diagnostic follow-up increase the detection of early-stage CRC; and
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: SMS RemindersThree SMS reminders spaced one week apart will be sent to the patient on top of usual care. |
| Arm C: SMS Reminders + Mailed Reminder | Active comparator | Behavioral: SMS reminders + mailed reminderThree 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. |
| Arm D: SMS Reminders + Mailed Reminder + Patient Navigation | Active comparator | Behavioral: SMS reminders + mailed reminder + patient navigationThree 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. |
| Arm E: SMS Reminders + Mailed Return | Active comparator | Behavioral: SMS reminders + mailed returnThree 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. |
| Arm F: SMS Reminders + Mailed FIT | Active comparator | Behavioral: SMS reminders + mailed FITA 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. |
| Arm G: SMS Reminders + Mailed FIT + Patient Navigation | Active comparator | Behavioral: SMS reminders + mailed FIT + patient navigationA 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- Prior diagnosis of CRC, advanced cancer, or palliative care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS Reminders5,000 patients will be allocated in this arm. | Behavioural | Arm B: SMS Reminders |
| SMS reminders + mailed reminder5,000 patients will be allocated in this arm. | Behavioural | Arm C: SMS Reminders + Mailed Reminder |
| SMS reminders + mailed reminder + patient navigation5,000 patients will be allocated in this arm. | Behavioural | Arm D: SMS Reminders + Mailed Reminder + Patient Navigation |
| SMS reminders + mailed return5,000 patients will be allocated in this arm. | Behavioural | Arm E: SMS Reminders + Mailed Return |
| SMS reminders + mailed FIT5,000 patients will be allocated in this arm. | Behavioural | Arm F: SMS Reminders + Mailed FIT |
| SMS reminders + mailed FIT + patient navigation5,000 patients will be allocated in this arm. | Behavioural | Arm G: SMS Reminders + Mailed FIT + Patient Navigation |
Primary outcome
FIT completion.
Time frame: 3 months.
By the end of 3 months, FIT completion rates will be analyzed as either completed or not completed.
4 secondary outcomes
Follow-up Colonoscopy completion after positive FIT screening.
Time frame: 6 months after positive FIT screening.
Diagnosis of CRC.
Time frame: 6 months.
Stage of CRC at diagnosis.
Time frame: 6 months.
Cancer-specific mortality.
Time frame: 4 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- BackgroundMinistry of Health S. National Population Health Survey (NPHS) 2024 Report. 2024.
- Background: PubMed 27769517Robertson 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.
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- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr CHUA Wei Yu contact
Dr Kennedy NG principal investigator
National Cancer Centre, Singapore
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS Reminders, SMS reminders + mailed reminder and SMS reminders + mailed reminder + patient navigation in people with Colorectal Cancer, run by National Cancer Centre, Singapore at 5 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ms LEE Kit Yee (+65 6346 8000, lee.kit.yee@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FIT completion. (time frame: 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07852793, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.