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临床试验/NCT06733155
NCT06733155已完成不适用

Pragmatic Randomized Trial to Evaluate the Impact of Various Interventions to Increase the Uptake of Surveillance Mammography in Eligible Women in Singapore

National University Hospital, Singapore1 个研究点 分布在 1 个国家目标入组 12,000 人开始时间: 2024年9月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12,000
试验地点
1
主要终点
Comparison of Mammogram Uptake Between Intervention Arms (2-5) and Control Arm

研究概览

简要总结

Breast cancer is the most common cancer among women in Singapore, with more than 70 women out of every 100,000 being diagnosed each year. Early detection through regular mammograms can significantly reduce deaths from breast cancer. Although Singapore has had a national breast cancer screening program (now part of the Screen for Life initiative) for over 20 years, and the government offers substantial subsidies to make screening more affordable, participation remains low at only 30-40%. This low uptake is due to factors like fear, lack of awareness, cultural beliefs, and a perceived low risk of breast cancer. To be effective on a large scale, at least 70% of women need to participate in regular mammography screenings. While researchers in Singapore and Asia have studied the reasons behind low screening rates, there is still a lack of large-scale studies that test different strategies to increase mammography participation in these regions.

This trial will recruit 12,000 women aged 50-69 who have not undergone a mammogram in the past two years. 9000 women will be randomized into five intervention arms. The interventions include: direct mail reminder (Arm 1, control, n=3000), financial incentive (Arm 2, n=1500), lottery incentive (Arm 3, n=1500), health messaging from an influential figure (Arm 4, n=1500), and personal health concierge for appointment scheduling (Arm 5, n=1500). Another 3000 women will be placed in a non-interventional arm (NI arm) for observational analysis, that receives no reminders at all. A post-intervention telephone survey will assess intervention effectiveness.

The primary outcome is mammogram uptake across intervention arms with Arm 1 as a reference. Secondary outcome will be to compare Arm 1 with NI arm. Subgroup analyses will evaluate differences in uptake by sociodemographic factors, such as ethnicity and socioeconomic status. A cost-effectiveness analysis will assess the financial viability of each intervention.

This is the first large-scale study in Singapore and Asia to compare multiple interventions to boost mammography uptake. Findings will provide evidence-based strategies to improve breast cancer screening participation, potentially reducing breast cancer mortality and informing future public health policy.

详细描述

This study aims to evaluate different interventions to boost breast cancer screening (mammography) participation among women in Singapore, aged 50-69, using data from the National University Health System (NUHS). 9000 eligible women will be randomized into one control arm and four experimental arms, receiving different combinations of reminders and incentives. Another 3000 women will be placed in an observational arm that receives no reminders at all. The study will use data from the NUHS electronic health records (EPIC) and NUHS app to monitor mammogram completion rates, exploring the effectiveness of each intervention.

Study Arms:

Control Group (Direct Mail Reminder): Receives a mail reminder with basic information about breast cancer and instructions on scheduling a mammogram.

Financial Incentive Group: Mail reminder + a $10 voucher for completing a mammogram within three months.

Lottery Incentive Group: Mail reminder + chance to win a $5000 lottery for completing the screening within three months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

入选标准

  • Singaporean citizen
  • Age 50-69
  • Registered as a patient at the National University Hospital
  • Registered and active user of OneNUHS App
  • Signed up with Healthier SG with a primary care provider within the NUHS Primary Care Network

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

Observational Arm

No Intervention

Does not receive any mailer reminder to go for mammogram.

Arm 1 (control)

Experimental

Receives a mail reminder with basic information about breast cancer and instructions on scheduling a mammogram

干预措施: Only reminder mailer (Other)

Arm 2: Financial incentive

Experimental

Receives mail reminder + a $10 voucher for completing a mammogram within three months.

干预措施: Financial intervention (Other)

Arm 3: Lottery incentive

Experimental

Receives mail reminder + chance to win a $5000 lottery for completing the screening within three months.

干预措施: Lottery intervention (Other)

Arm 4: Health messaging

Experimental

Receives mail reminder + QR code to a 60-second video from an influential person, available in four languages (English, Chinese, Malay, Tamil).

干预措施: Health Messages (Other)

Arm 5: Personal Health Concierge

Experimental

Receives mail reminder + a dedicated hotline for scheduling mammograms with the help of a health concierge over eight weeks.

干预措施: Personal Health Concierge (Other)

结局指标

主要结局

Comparison of Mammogram Uptake Between Intervention Arms (2-5) and Control Arm

时间窗: 3 month from study start or 4 months from randomization

Primary endpoint: Comparison of the proportion of women who undergo surveillance mammography among participants in Arms 2-5 versus Arm 1 (control arm).

Comparison of Mammogram Uptake Between Intervention Arms (2-5) and Control Arm (Arm 1)

时间窗: 4 months from randomization

Primary endpoint: Comparison of the proportion of women who undergo surveillance mammography among participants in Arms 2-5 versus Arm 1 (control arm).

次要结局

  • Comparison of Mammogram Uptake Between Non-Interventional Arm (NI Arm) vs Control Arm (Arm 1)(4 months from randomization)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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