- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05048641
Effectiveness of Mobile Messenger-initiated Reminder on Biannual Mammography Adherence in Breast Cancer Screening
Female breast cancer is the most common cancer and fifth leading cause of cancer death worldwide. In the past decade, breast cancer consistently to be the most common cancer for women in Hong Kong, so much that it accounts for 27% of all female cancers, with 4,600 new cases of breast cancer registration every year and the lifetime breast cancer risk for females is 1 in every 14. At the same time, breast cancer ranks the third in cancer death in Hong Kong, with a five-year relative survival rate of 84%. Regular mammography screening has been shown to reduce the mortality of breast cancer. International guidelines recommend annual or biannual mammography screening for women aged 50 or above.
The adherence to regular mammography screening remains a challenge. Studies had shown that the adherence decreased over time. Mailed and telephone reminder were being proven to be effective tools to increase the adherence to regular breast screening using mammography. However, both mailing and telephone strategies are associated with labor intensity and high cost.
Over the past two decades, the advent of internet and smartphone provided a fertile platform for the development of mobile-health technologies. WhatsApp Messenger is one of the most frequently used free-of-charge mobile messenger that permits users to send secure messages across different device platforms. A recent randomized controlled trial from our team has suggested its clinical utility in improving adherence to regular colorectal cancer screening using fecal immunochemical test. This encouraging data prompted us to investigate the potential role of WhatsApp Messenger in breast cancer screening. We hypothesized that text reminder sent via WhatsApp Messenger improves the longitudinal adherence to biannual mammography in a community-based, opportunistic breast screening program.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yuen Tung Lam, PhD
- Phone Number: 26370428
- Email: thomaslam@cuhk.edu.hk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women with negative mammography results which are defined as BI-RADS (Breast Imaging-Reporting and Data System) 1 or 2 in the first round of mammography screening of the existing opportunistic breast cancer screening cohort
- Due for second round of biannual follow up of mammography
- Consented to be contacted via WhatsApp Messenger
Exclusion Criteria:
- Those without access to WhatsApp Messenger or disagreed to be contacted via WhatsApp Messenger
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: WhatsApp Reminder group
Subjects who are allocated to the intervention group received reminder via WhatsApp Messenger at one month before the scheduled calendar month of biannual mammography follow-up.
|
Subjects who are allocated to the intervention group received reminder via WhatsApp Messenger at one month before the scheduled calendar month of biannual mammography follow-up.
|
|
NO_INTERVENTION: No Reminder (NR) group
Subjects who are allocated to the NR group received standard-of-care service which is no reminder text messages via WhatsApp Messenger prior to their scheduled repeat mammography and no follow up phone reminder until the completion of the outcome measurement period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Attendance of the second round of mammography follow up and repeat mammography arrangement.
Time Frame: Through study completion, an average of 2 years
|
Primary outcome is the adherence to biannual mammography screening, defined as attendance to the second round of mammography follow up and attendance to the repeat mammography arrangement.
|
Through study completion, an average of 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Risk factors of nonadherence based on all available variables of patients' characteristics
Time Frame: Through study completion, an average of 2 years
|
Secondary outcomes are the risk factors of nonadherence which will be determined by binary logistic regression analysis using all available variables of patients' characteristics
|
Through study completion, an average of 2 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
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
- 2021.240
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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