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

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

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.

Study Overview

Detailed Description

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.

Health Messaging Group: Mail reminder + QR code to a 60-second video from an influential person, available in four languages (English, Chinese, Malay, Tamil).

Personal Health Concierge Group: Mail reminder + a dedicated hotline for scheduling mammogram with the help of a health concierge over eight weeks.

Selection and Randomization:

Eligible participants will be selected from over 500,000 registered users of the OneNUHS app. Randomization will be done using a random number generator, with control and experimental arms receiving a 2:1 ratio. Data collected include basic demographic details and mammogram history, extracted securely from the EPIC system.

Data Collection:

Women in each arm will receive a physical mailer and three push notifications over three weeks, instructing them to schedule a mammogram at any approved screening center. Data on mammogram attendance will be extracted from EPIC post-study, and a subset of participants will be surveyed to gather feedback.

Primary and Secondary Endpoints:

The study will compare mammogram participation rates between the control and experimental arms, with secondary analyses exploring the uptake rates of arm 1 and NI arm as well as, impact of ethnicity, age, and income (via housing type) on outcomes. Additionally, a cost-effectiveness analysis will assess the impact of interventions on breast cancer detection and healthcare savings.

Follow-up and Evaluation:

A post-trial telephone survey of 750 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.

Study Type

Interventional

Enrollment (Estimated)

12000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore
        • National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Observational Arm
Does not receive any mailer reminder to go for mammogram.
Experimental: Arm 1 (control)
Receives a mail reminder with basic information about breast cancer and instructions on scheduling a mammogram
Receives a mail reminder with basic information about breast cancer and instructions on scheduling a mammogram.
Experimental: Arm 2: Financial incentive
Receives mail reminder + a $10 voucher for completing a mammogram within three months.
Participants completing the mammogram within the study end date will receive a $10 voucher.
Experimental: Arm 3: Lottery incentive
Receives mail reminder + chance to win a $5000 lottery for completing the screening within three months.
Participants completing the mammogram within the study end date will receive achance to win a $5000 lottery.
Experimental: Arm 4: Health messaging
Receives mail reminder + QR code to a 60-second video from an influential person, available in four languages (English, Chinese, Malay, Tamil).
Participants will receive a less than 5 minute long video from an influential person. The video will be available in four languages (English, Chinese, Malay, Tamil).
Experimental: Arm 5: Personal Health Concierge
Receives mail reminder + a dedicated hotline for scheduling mammograms with the help of a health concierge over eight weeks.
Participants will be able to call a dedicated hotline for scheduling mammograms with the help of a health concierge over eight weeks of receive the the mailer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Mammogram Uptake Between Intervention Arms (2-5) and Control Arm
Time Frame: 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).
3 month from study start or 4 months from randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2024

Primary Completion (Actual)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 10, 2024

First Submitted That Met QC Criteria

December 10, 2024

First Posted (Actual)

December 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2025

Last Update Submitted That Met QC Criteria

May 19, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2023/01007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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