NCT05048641

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jun 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

12 months

First QC Date

August 30, 2021

Last Update Submit

April 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Through study completion, an average of 2 years

Secondary Outcomes (1)

  • Risk factors of nonadherence based on all available variables of patients' characteristics

    Through study completion, an average of 2 years

Study Arms (2)

WhatsApp Reminder group

EXPERIMENTAL

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.

Other: Whatsapp reminder

No Reminder (NR) group

NO INTERVENTION

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.

Interventions

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.

WhatsApp Reminder group

Eligibility Criteria

Age50 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Those without access to WhatsApp Messenger or disagreed to be contacted via WhatsApp Messenger

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Yuen Tung Lam, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

August 30, 2021

First Posted

September 17, 2021

Study Start

June 1, 2022

Primary Completion

May 31, 2023

Study Completion

May 31, 2024

Last Updated

April 15, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share