이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Mailed FIT-Based Outreach Interventions

2026년 9월 28일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

40000

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

50년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
간섭 없음: Arm A: Usual Care

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

활성 비교기: 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.

활성 비교기: 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.

활성 비교기: 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.

활성 비교기: 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.

활성 비교기: 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.

활성 비교기: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
FIT completion.
기간: 3 months.

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

3 months.

2차 결과 측정

결과 측정
측정값 설명
기간
Follow-up Colonoscopy completion after positive FIT screening.
기간: 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.
기간: 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.
기간: 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.
기간: 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.

기타 결과 측정

결과 측정
측정값 설명
기간
Cost-effectiveness of the screening programme.
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

수사관

  • 수석 연구원: Dr Kennedy NG, National Cancer Centre, Singapore

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 10월 30일

기본 완료 (추정된)

2029년 10월 30일

연구 완료 (추정된)

2030년 10월 30일

연구 등록 날짜

최초 제출

2026년 9월 21일

QC 기준을 충족하는 최초 제출

2026년 9월 28일

처음 게시됨 (실제)

2026년 10월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 28일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • CRC-001

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .