此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Mailed FIT-Based Outreach Interventions

2026年9月28日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

40000

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

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

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 至 80年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:Arm A: Usual Care

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

有源比较器: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.

有源比较器: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.

有源比较器: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.

有源比较器: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.

有源比较器: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.

有源比较器: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
FIT completion.
大体时间:3 months.

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

3 months.

次要结果测量

结果测量
措施说明
大体时间
Follow-up Colonoscopy completion after positive FIT screening.
大体时间: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.
大体时间: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.
大体时间: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.
大体时间: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.

其他结果措施

结果测量
措施说明
大体时间
Cost-effectiveness of the screening programme.
大体时间: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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Dr Kennedy NG、National Cancer Centre, Singapore

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月30日

初级完成 (估计的)

2029年10月30日

研究完成 (估计的)

2030年10月30日

研究注册日期

首次提交

2026年9月21日

首先提交符合 QC 标准的

2026年9月28日

首次发布 (实际的)

2026年10月1日

研究记录更新

最后更新发布 (实际的)

2026年10月1日

上次提交的符合 QC 标准的更新

2026年9月28日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅