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Trial to Evaluate the Impact of Various Pragmatic Interventions to Increase Mammography Uptake Among Defaulted Repeat Screeners in Singapore (REMIND1)

2026年6月10日 更新者:National University Hospital, Singapore

Randomized Controlled Trials to Evaluate Outreach Strategies for Increasing Mammogram Uptake in Singaporean Women Who Are Defaulted Repeat Screeners

Breast cancer is the most common cancer among women in Singapore, accounting for nearly 30% of all female cancers. While regular biennial mammography can reduce mortality, screening rates in Singapore remain low at 34.7%; well below the 70% threshold required for population-level impact. Despite a national screening program in place since 2002, uptake continues to be hindered by psychological, cultural, and logistical barriers. Although various studies have explored different behavioural interventions to boost mammogram uptake; ranging from reminders (traditional mailers, phone calls, text messages) and education to financial incentives, their effectiveness varies by population and context. Furthermore, few large-scale, prospective studies have been conducted locally. Prior research in Singapore is either outdated or limited in scope, and there is a particular lack of rigorous trials evaluating behavioral interventions tailored to women who have defaulted on screening, who faces distinct psychological and behavioral barriers; ranging from low perceived risk and fear, to false reassurance from prior normal results or lack of reminders, or had bad experience (procedural pain or prior false positive results) during last mammogram. Engaging these women is critical, yet challenging, and failure to do so undermines efforts to achieve broad population coverage.

The REMIND Study addresses this critical gap by evaluating five pragmatic and scalable outreach strategies to increase mammogram uptake among women who had their last screening more than 2 years ago and are currently overdue. Through a large, randomized controlled trial, the study will generate much-needed local evidence on what works to reengage these women. Findings will directly inform national screening policies and the design of future outreach efforts tailored to Singapore's diverse population.

研究概览

详细说明

The REMIND Study is a five-arm randomized controlled trial (RCT) designed to evaluate the effectiveness of a few behavioral interventions to increase mammogram uptake among women aged 50-69 years who have defaulted on mammogram screening. The study's specific aim is to identify effective, affordable, and scalable behavioral interventions that can be implemented in Singapore's general population to improve participation in surveillance mammography. This is a minimal-risk, population-based study that does not require participant visits or in-person interaction, except for a subset involved in a follow-up telephone survey.

Eligibility Criteria: Singaporean women, aged 50-69, who are eligible for free biennial mammograms, with no history of prior breast cancer, have had at least one mammogram before, but not screened in the past 2 years will be will be identified using the NUH electronic medical health records system (EPIC). We will restrict the selection to NUHS patients who are registered users of the NUHS App. To further select/narrow down the eligible participants app activity or last log in date will be used. Patients who signed up the NUHS App have all consented to receive push notifications on research studies. There are over 600,000 registered users of NUHS App. The required 12,750 patients for the study will be randomly selected from these eligible patients.

Randomization and Intervention Arms: A total of 12,750 eligible women will be randomly assigned in equal proportions (n=2,550 per arm) to one of the following five groups:

  1. no intervention (control);
  2. standard mailed reminder (MR);
  3. MR plus a second MR sent four weeks later;
  4. MR with a pre-scheduled mammogram appointment; and
  5. MR containing behavioral nudge messaging (e.g., social norm or gain or loss framing techniques).

Randomization will be computer-generated. NOTE: Arm 1 represents the current standard practice at NUHS, where patients are not routinely invited or reminded to attend mammogram screenings.

Women in intervention arms 2-5 will receive their respective outreach materials by post (personalized mailers on NCIS letter head) as well as push notifications via the NUHS app. 5-7 days after the mailers are sent, 1st batch of PN will be sent. Up to three batches of PN will be sent to all participants in Arms 2-5, 3 weeks apart. The push notifications will either be linked to a microcontent landing page or a webpage on NCIS website. The content of the mailers and landing page/ webpage will be the same explaining the importance of regular mammography, tailored messages according to each intervention type, and relevant booking instructions or appointment details. These materials have been designed to reflect evidence-based behavioral science strategies and were co-developed in consultation with clinicians, behavioural science experts, and community stakeholders. Participants in the control arm (Arm 1) will not receive any intervention.

This is a minimal-risk study. There are no in-person visits, clinical procedures, or additional tests required. Participation primarily involves receiving reminders. Women may choose to opt out of the study at any time.

Outcome measurement: All data on mammogram completion will be obtained from existing sources such as electronic medical records and the national screening registry. The primary outcome is mammogram uptake within four months of the first intervention (date of sending the mailer/ push notification, which ever is later). In addition to the primary time point, mammogram uptake data may also be extracted at the 6-month and 12-month marks following the intervention. These extended follow-up points will allow for the assessment of any delayed uptake, which may help to understand the longer-term impact of the interventions. No new clinical data will be generated from participants.

NOTE: To avoid a huge surge in calls to the appointment booking hotline number, mailers will be sent in a staggered manner over 4-12 weeks. Hence, the collection of mammogram completion data will also be staggered and will be 4 months from the day of sending the mailers/PNs which ever is the later. Similarly, for the participants in Arm 4 (mailer reminder with pre-scheduled appointment), the mailers/PN will be sent out 4-6 weeks prior to the appointment date and the mammogram completion date will be calculated four months from the date the mailer/PN was sent.

Post-trial telephone survey: In addition post-trial, a subset of participants from Arms 2-5, will be randomly selected to participate in a telephone survey aimed at understanding motivations, barriers, and perceptions related to the interventions and screening. Participants will be randomly selected and contacted until a total of up to 70 participants in each arm responds and takes part in the survey. About 3-8 weeks post trial, the participants will be contacted via phone, and verbal consent will be obtained prior to initiating the survey. They will be informed that the survey will take about 5-10 minutes, their participation is voluntary, they may skip any question or withdraw at any time, and their responses will remain confidential. Trained research staff will be performing the telephone survey.

研究类型

介入性

注册 (估计的)

12750

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。

学习地点

      • Singapore、新加坡
        • National University Hospital Singapore

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

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Singaporean citizen
  • Age 50-69
  • Registered as a patient at the National University Hospital
  • Registered and active user of NUHS App
  • Signed up with Healthier SG with a primary care provider within the NUHS Primary Care Network
  • Must be defaulted repeat screeners : Must have done one prior mammogram screening but not in the past 2 years

Exclusion Criteria:

  • Diagnosis of breast cancer in EPIC
  • Mammogram done in the past 24 months in EPIC

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:放映
  • 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
实验性的:第5组:邮寄增强信息提醒
收到附带增强信息的邮寄提醒
Receives one mailed reminder with enhanced messaging motivating recipient to undergo screening
无干预:Control Arm (Arm 1)
Does not receive any reminder to go for mammogram
实验性的:Arm 2: One mailed reminder
Receives a single mail reminder
收到邮寄的提醒信,内含乳腺癌基本信息以及安排乳腺X光检查的说明
实验性的:Arm 3: Two mailed reminders
Receives two mail reminders, 4 weeks apart
Receives a mailed reminder + follow-up mailed reminder, 4 weeks after the first
实验性的:Arm 4: Mailed Reminder with Prescheduled Appointment
Receives a mailed reminder with prescheduled appointment
收到一封包含预约时间的邮件提醒,并附有更改预约的说明

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
Comparison of proportion of participants completing surveillance mammography within 4 months after intervention assignment between interventional arms (2-5) and control arm (Arm 1)
大体时间:4 months from the time participants receive the intervention/reminder
The proportion of women who undergo surveillance mammography within 4 months of receiving the study intervention/reminder will be compared between Arm 1 (control) and Arms 2-5. Mammogram completion will be confirmed through electronic medical records. Results will be reported as the percentage of participants completing mammography in each study arm. Unit of Measure: Percentage of participants (%)
4 months from the time participants receive the intervention/reminder

次要结果测量

结果测量
措施说明
大体时间
试验后6个月和12个月的乳房X光检查参与率
大体时间:从参与者收到第一封邮寄提醒信起的6个月和12个月
初始研究后6个月和12个月的乳腺X光检查完成情况对比
从参与者收到第一封邮寄提醒信起的6个月和12个月
Association between participant characteristics and completion of surveillance mammography within 4 months
大体时间:4 months from the time participants receive the intervention/reminder
Multivariable logistic regression will be used to evaluate the association between participant characteristics and mammogram completion within 4 months after intervention. Covariates include age, race, housing type, and duration overdue for screening. Results will be reported as adjusted odds ratios with 95% confidence intervals.
4 months from the time participants receive the intervention/reminder
Post-trial telephone survey
大体时间:1-2 months post-trial
A post-trial telephone survey of about 280 participants will gather insights into their response to the interventions. The study aims to provide actionable insights into effective, scalable interventions to improve mammography uptake and reduce breast cancer mortality in Singapore.
1-2 months post-trial

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。

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 (实际的)

2026年3月9日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2027年12月31日

研究注册日期

首次提交

2026年5月21日

首先提交符合 QC 标准的

2026年6月10日

首次发布 (实际的)

2026年6月16日

研究记录更新

最后更新发布 (实际的)

2026年6月16日

上次提交的符合 QC 标准的更新

2026年6月10日

最后验证

2026年4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)?

不

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.

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