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Mailed FIT-Based Outreach Interventions

28 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

40000

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 50 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Arm A: Usual Care

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

Comparatore attivo: 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.

Comparatore attivo: 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.

Comparatore attivo: 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.

Comparatore attivo: 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.

Comparatore attivo: 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.

Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
FIT completion.
Lasso di tempo: 3 months.

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

3 months.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Follow-up Colonoscopy completion after positive FIT screening.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Cost-effectiveness of the screening programme.
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Collaboratori

Investigatori

  • Investigatore principale: Dr Kennedy NG, National Cancer Centre, Singapore

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 ottobre 2026

Completamento primario (Stimato)

30 ottobre 2029

Completamento dello studio (Stimato)

30 ottobre 2030

Date di iscrizione allo studio

Primo inviato

21 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

28 settembre 2026

Primo Inserito (Effettivo)

1 ottobre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • CRC-001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .