search
Back to results

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
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    August 30, 2021
    Last Updated
    April 14, 2022
    Sponsor
    Chinese University of Hong Kong
    search

    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