Randomized Controlled Trials to Evaluate Outreach Strategies for Increasing Mammogram Uptake in Singaporean Women Who Are Defaulted Repeat Screeners
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 12,750
- 试验地点
- 1
- 主要终点
- Comparison of proportion of participants completing surveillance mammography within 4 months after intervention assignment between interventional arms (2-5) and control arm (Arm 1)
研究概览
简要总结
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 Prior research in Singapore is either outdated or limited in scope, and there is a particular lack of rigorous trials evaluating behavioral interventions tailored to women who have defaulted on screening,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.
详细描述
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:
- no intervention (control);
- standard mailed reminder (MR);
- MR plus a second MR sent four weeks later;
- MR with a pre-scheduled mammogram appointment; and
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Diagnosis of breast cancer in EPIC
- •Mammogram done in the past 24 months in EPIC
研究组 & 干预措施
Control Arm (Arm 1)
Does not receive any reminder to go for mammogram
Arm 2: One mailed reminder
Receives a single mail reminder
干预措施: Arm 2: One mailed reminder (Behavioral)
Arm 3: Two mailed reminders
Receives two mail reminders, 4 weeks apart
干预措施: Arm 3: Two mailed reminders (Behavioral)
Arm 4: Mailed Reminder with Prescheduled Appointment
Receives a mailed reminder with prescheduled appointment
干预措施: Arm 4: Mailed reminder with prescheduled appointment (Behavioral)
Arm 5: Mailed reminder with enhanced messaging
Receives mailed reminder with enhanced messaging
干预措施: Arm 5: Mailed reminder (Behavioral)
结局指标
主要结局
Comparison of proportion of participants completing surveillance mammography within 4 months after intervention assignment between interventional arms (2-5) and control arm (Arm 1)
时间窗: 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 (%)
次要结局
- Association between participant characteristics and completion of surveillance mammography within 4 months(4 months from the time participants receive the intervention/reminder)
- Post-trial telephone survey(1-2 months post-trial)
- Mammogram uptake at 6 and 12 months post-trial(6 and 12 months from the time participants received the first mailed reminder)