- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07852793
Mailed FIT-Based Outreach Interventions
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Ms LEE Kit Yee
- Telefonnummer: +65 6346 8000
- E-mail: lee.kit.yee@singhealth.com.sg
Undersøgelse Kontakt Backup
- Navn: Dr CHUA Wei Yu
- E-mail: chua.wei.yu@mohh.com.sg
Studiesteder
-
-
-
Singapore, Singapore
- Singapore General Hospital
-
Kontakt:
- Prof Emile John TAN Kwong Wei, MBBS, FRCS
-
Singapore, Singapore, 529889
- Changi General Hospital
-
Kontakt:
- A/Prof Andrew KWEK Boon Eu, MBBS, MRCP
-
Singapore, Singapore, 544886
- Sengkang General Hospital
-
Kontakt:
- Dr Clarence KWAN Kah Wai, MBBS, MRCP
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Singapore, Singapore, 168583
- National Cancer Center, Singapore
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Kontakt:
- Dr Kennedy NG, MBBS (Hons), MRCP, MPA
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Singapore, Singapore, 150167
- SingHealth Polyclinic
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Kontakt:
- Dr KOH Kim Hwee, MBBS
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Arm A: Usual Care
CRC screenings are recommended opportunistically by primary care providers during routine healthcare visits. |
|
|
Aktiv komparator: Arm B: SMS Reminders
Three SMS reminders spaced one week apart will be sent to the patient on top of usual care. |
5,000 patients will be allocated in this arm. |
|
Aktiv komparator: 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. |
5,000 patients will be allocated in this arm. |
|
Aktiv komparator: 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. |
5,000 patients will be allocated in this arm. |
|
Aktiv komparator: 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. |
5,000 patients will be allocated in this arm. |
|
Aktiv komparator: 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. |
5,000 patients will be allocated in this arm. |
|
Aktiv komparator: 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. |
5,000 patients will be allocated in this arm. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
FIT completion.
Tidsramme: 3 months.
|
By the end of 3 months, FIT completion rates will be analyzed as either completed or not completed. |
3 months.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Follow-up Colonoscopy completion after positive FIT screening.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Cost-effectiveness of the screening programme.
Tidsramme: 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.
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Dr Kennedy NG, National Cancer Centre, Singapore
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- Ministry of Health S. National Population Health Survey (NPHS) 2024 Report. 2024.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Tarmsygdomme
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Tyktarmssygdomme
- Kolorektale neoplasmer
- Sundhedstjenester Administration
- Patientplejestyring
- Omfattende sundhedspleje
- Patientcentreret pleje
- Primær sundhedspleje
- Patientnavigation
Andre undersøgelses-id-numre
- CRC-001
Plan for individuelle deltagerdata (IPD)
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