- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07283107
Trial to Evaluate the Impact of Various Behavioural Interventions to Increase Mammography Uptake Among Singaporean Women (PROMPT)
Two Parallel Randomized Controlled Trials to Evaluate Outreach Strategies for Increasing Mammogram Uptake in Women Who Have Never Screened or Are Due for Repeat Screening
Study Overview
Status
Detailed Description
The study comprises two parallel randomized controlled trials targeting two distinct populations: (1) Women who have never undergone a mammogram ("Never Screeners"): Eligibility criteria- Singaporean women, aged 50-69, who are eligible for free biennial mammograms but have not gone for mammogram yet, with no history of prior breast cancer, will be identified using the NUH electronic medical health records system (EPIC). The selection will be restricted to NUHS patients who are registered users of the NUHS App. To further select/narrow down the eligible participants, app-activity/ last login date will be used (Active app user is defined as having used the app at least once within 12 months of the study start date. If there are not enough active NUHS app user, the last login interval will be increased to 18 to 24 months until sufficient eligible participants are obtained. If the last login needs to be extended beyond 24 months, IRB approval will be sought). The required 3,000 patients for the study will be randomly selected from these eligible patients.(2) Women who have undergone mammogram in the past 2 years but not scheduled a repeat screening yet ("Recent Screeners"): Eligibility criteria- Singaporean women, aged 50-69, who are eligible for free biennial mammograms and have gone for mammogram in the past 18-24 months but have not scheduled an appointment for repeat screening yet, with no history of prior breast cancer, will be identified using the NUH electronic medical health records system (EPIC). Selection will be restricted to NUHS patients who are registered users of the NUHS App (as defined above). The required 5,910 patients for the study will be randomly selected from these eligible patients.
The study will enroll a total of 3000 never-screeners (600 participants in each arm) and 5910 recent screeners (1182 participants in each arm) across 5 intervention groups. Sample size calculations were performed to ensure 90% power at a two-sided significance level of 5% (α = 0.05) to detect a clinically meaningful difference in the primary outcome, defined as an absolute increase of 7% in mammogram uptake. The study employs a ≥"pick-the-winner" design, wherein each intervention arm (Arms 2-5) is compared individually against the control arm (Arm 1). An intervention will be considered successful if it demonstrates at least a 7% absolute improvement in uptake relative to the control.
Statistical analysis plan: Pairwise comparisons between each intervention arm (Arms 2-5) and the control arm (Arm 1) will be performed using logistic regression to estimate the odds ratios (ORs), absolute differences in proportions, and 95% confidence intervals (CIs) for mammogram uptake.
Primary endpoint: 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, whichever is later). Uptake data might be also extracted at the 6 and 12 month time-point to see if there was any additional uptake. 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. Screening behavior will be assessed through electronic medical record (EMR) review, specifically from the National University Health System's (NUHS) mammography booking and screening databases (the national screening registry). Data extracted will include mammogram booking and attendance status, date of screening (if any), and relevant demographic details. All data on mammogram completion will be obtained from existing sources such as electronic medical records. Findings will provide evidence-based strategies to improve breast cancer screening participation, potentially reducing breast cancer mortality and informing future public health policy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Singapore, Singapore
- National University Hospital Singapore
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
- For "never-screener" cohort: Must have never undergone mammogram screening
- For "repeat-screener" cohort : Must have completed screening in the last 18-24 months but have not booked their next appointment yet
Exclusion Criteria:
- Diagnosis of breast cancer in EPIC
- Mammogram done in the past 24 months in EPIC
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control Arm (Arm 1)
Does not receive any reminder to go for mammogram.
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Experimental: Arm 2: : One mailed reminder
Receives a single mail reminder
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Receives a mailed reminder with basic information about breast cancer and instructions on scheduling a mammogram
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Experimental: Arm 3: Two mailed reminders
Receives two mail reminders, 1 month apart
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Receives a mailed reminder + follow-up mailed reminder, 1 month after the first reminder
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Experimental: Arm 4: Mailed Reminder with Prescheduled Appointment
Recieves a mailed reminder with prescheduled appointment
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Receives one mailed reminder with a pre-scheduled appointment, with instructions to change appointment
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Experimental: Arm 5: Mailed reminder with enhanced messaging
Receives mailed reminder with enhanced messaging
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Receives one mailed reminder with enhanced messaging motivating recipient to undergo screening
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of Mammogram Uptake Between Interventional Arms (2-5) and Control Arm (Arm 1)
Time Frame: 4 months from the time participants receive the reminders
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Comparison of the proportion of women who undergo surveillance mammography among participants in Arms 2-5 versus Arm 1 (control arm).
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4 months from the time participants receive the reminders
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact of social and demographic factors on mammogram completion.
Time Frame: 4 months from the time participants receive the reminder
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Impact of ethnicity, age, and income (via housing type) on outcomes will be assessed
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4 months from the time participants receive the reminder
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Post-trial telephone survey
Time Frame: 1-2 months post-trial
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A post-trial telephone survey of 750 participants for each cohort (never screeners and repeat screeners) 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.
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1-2 months post-trial
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Mammogram uptake at 6 and 12 months post-trial
Time Frame: 6 and 12 months from the time participants received the first mailed reminder
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Comparison of mammogram completion 6 and 12 months after the initial study
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6 and 12 months from the time participants received the first mailed reminder
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Collaborators and Investigators
Investigators
- Principal Investigator: Soo-Chin Lee, MBBS, MRCP, National University Hospital Singapore, Singapore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-0880
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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