Effectiveness of Mobile Messenger-initiated Reminder on Biannual Mammography Adherence in Breast Cancer Screening
Primary Purpose
Breast Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Whatsapp reminder
Sponsored by
About this trial
This is an interventional screening trial for Breast Cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
WhatsApp Reminder group
No Reminder (NR) group
Arm Description
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 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.
Outcomes
Primary Outcome Measures
Attendance of the second round of mammography follow up and repeat mammography arrangement.
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.
Secondary Outcome Measures
Risk factors of nonadherence based on all available variables of patients' characteristics
Secondary outcomes are the risk factors of nonadherence which will be determined by binary logistic regression analysis using all available variables of patients' characteristics
Full Information
NCT ID
NCT05048641
First Posted
August 30, 2021
Last Updated
April 14, 2022
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05048641
Brief Title
Effectiveness of Mobile Messenger-initiated Reminder on Biannual Mammography Adherence in Breast Cancer Screening
Official Title
Effectiveness of Mobile Messenger-initiated Reminder on Biannual Mammography Adherence in Breast Cancer Screening
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
WhatsApp Reminder group
Arm Type
Experimental
Arm Description
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.
Arm Title
No Reminder (NR) group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Whatsapp reminder
Intervention Description
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.
Primary Outcome Measure Information:
Title
Attendance of the second round of mammography follow up and repeat mammography arrangement.
Description
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.
Time Frame
Through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
Risk factors of nonadherence based on all available variables of patients' characteristics
Description
Secondary outcomes are the risk factors of nonadherence which will be determined by binary logistic regression analysis using all available variables of patients' characteristics
Time Frame
Through study completion, an average of 2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuen Tung Lam, PhD
Phone
26370428
Email
thomaslam@cuhk.edu.hk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Mobile Messenger-initiated Reminder on Biannual Mammography Adherence in Breast Cancer Screening
We'll reach out to this number within 24 hrs