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NCT Number: NCT06722469

A Randomized Controlled Trial to Increase Breast Cancer Screening Uptake

Breast cancer (BC) is the fifth leading cause of cancer deaths in women worldwide. In Hong Kong (HK), BC is the most common cancer, ranking third in cancer deaths among females. International guidelines advocate regular mammographic screening for women aged 40-50 to 69-74, reducing BC mortality by 20%.

The success and effectiveness of an organized cancer screening program are largely dependent on high adherence or uptake rates. However, nonadherence to BC screening is common and the suboptimal uptake rate remains a challenge, particularly in Asian countries.

Conventional interventions are effective in increasing mammographic screening uptake but are time-consuming, labor-dependent, and expensive. Mobile messenger chatbots are a potential cost-saving tool for enhancing BC screening uptake because they involve only a one-off development cost and a small maintenance cost . Currently, most studies evaluating the effectiveness of mobile health interventions in improving mammography screening uptake have been conducted in Western populations . Health-seeking behaviors for cancer screening in the Chinese population differ from those of Caucasians because of differences in culture, health beliefs, and education, especially regarding breast-related diseases. Chinese women often feel embarrassed when talking with healthcare workers in person about breast health. Communicating with a fully automated chatbot can minimize embarrassment. Additionally, linguistically and culturally tailored interventions are effective in increasing cancer screening rates in the Chinese population.

However, studies evaluating combined theory-based mHealth interventions to enhance BC screening uptake are scarce. Two theory-based WhatsApp chatbots were developed to promote CRC screening, and the longitudinal repeat fecal immunochemical test (FIT) adherence rate of a population-based CRC screening program in HK. These two chatbots used in investigator's previous studies had designs similar to that of the proposed chatbot, except for the health education materials. The chatbot design can be adopted directly with minor modifications to the workflow, replacement of content from CRC screening-related to BC screening-related, and culturally modified education materials. Consequently, the investigators can develop a new chatbot for this study at a lower cost and in a shorter time.

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Key information

Age range

44 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

In the past two decades, internet and mobile phone usage has increased due to affordability. The COVID-19 pandemic has further necessitated online and phone-based healthcare, paving the way for less labor-intensive, cost-effective mHealth interventions. These include short message service (SMS) text messages, telephone calls, email, social media, and mobile apps, which have significantly boosted BC screening uptake by 1.2%-50.9%. Among them, manual calls and SMS are prevalent methods. Manual calls facilitate interactions with subjects, aiding informed decision-making and participation but require high manpower. Although SMS offers automatic communication and chatbot features, each message costs approximately HKD$0.2, posing long-term economic challenges, especially for population-based interventions. Conversely, chatbots based on mobile messengers, like WhatsApp are less expensive due to unlimited free text and multimedia messaging across different mHealth operating systems. WhatsApp is globally prevalent, including in HK and has been successfully implemented in various clinical settings. Given these promising results, the investigators believe that mobile messenger-initiated chatbots have an extended role in the BC screening uptake rate because of the ubiquity, acceptability, and effectiveness of mHealth interventions. However, studies evaluating combined theory-based mHealth interventions to enhance BC screening uptake are scarce.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • asymptomatic Chinese Women
  • 44-69 years old
  • eligible to enroll in a government-subsidized risk-stratified BC screening program
  • ability to read Chinese

Exclusion criteria

  • moderate- or high-risk women as defined by the local risk-stratified BC screening program
  • inability to provide informed consent
  • incomplete conversation with the chatbot.

Treatment and study plan

WCI

Other

The WCI group will receive automated messages based on the Health Belief Model (HBM) and Protection Motivation Theory (PMT), including personalized risk assessments, educational videos featuring medical professionals and relatable scenarios, and tailored prompts to encourage mammographic screening.

Primary outcomes

  1. BCS uptake rate

    Time frame: Within three months after the intervention

    The primary outcome is the BC screening uptake rate, defined as participation in and completion of mammographic screening within three months after the intervention.

Secondary outcomes

  1. BCS uptake rate

    Time frame: Six months after the intervention

    BC screening uptake rate within six months after the intervention

  2. Risk factors related to BCS non-adherence by interview

    Time frame: Six months after the intervention

    Risk factors associated with breast cancer screening non-adherence will be collected by focused group discussion

  3. Mammography results

    Time frame: Six months after the intervention

    Number of positive mammography results of subjects who completed mammography

  4. Mammograph breast biopsy rate

    Time frame: Six months after the intervention

    Uptake rate of subsequent breast biopsy for those with positive mammographic results

  5. Detection rate of breast cancer

    Time frame: Six months after the intervention

    Detection rate of breast cancer

Study contacts

Contact information is provided by the study sponsor or research team.

Felix Sia, Master of Science

CONTACT

[email protected]

26370428

Thomas Lam, PhD in Medical Science

CONTACT

[email protected]

852-26370428

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

A Randomized Controlled Trial Evaluating a Mobile Messenger-initiated, Theory-based, Culturally Tailored, and Fully Automated Chatbot to Increase Breast Cancer Screening Uptake

Acronym: BCS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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