Breast Cancer PreventionBCSNCT06722469
A Randomized Controlled Trial to Increase Breast Cancer Screening Uptake
A study testing WCI in people with Breast Cancer Prevention and Breast Cancer Risk, run by Chinese University of Hong Kong.
Trial summary
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%. Read more about this study
- Who is it for?
- Ages 44 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Prevention, Breast Cancer Risk
- What is being tested?
- WCI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 44 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- asymptomatic Chinese Women
- 44-69 years old
- eligible to enroll in a government-subsidized risk-stratified BC screening program
- ability to read Chinese
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Controlled Trial Evaluating a Mobile Messenger-initiated, Theory-based, Culturally Tailored, and Fully Automated Chatbot 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Breast Cancer Prevention, Breast Cancer Risk
- Being tested
- WCI
- Keywords
- breast cancer, automated chatbot, breast cancer screening, health belief model
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WCIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| WCI | Experimental | 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. Receives: Other: WCI |
| STR | No intervention | A standard tet reminder will be sent regarding the breast cancer screening program |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCS uptake rate
The primary outcome is the BC screening uptake rate, defined as participation in and completion of mammographic screening within three months after the intervention.
Measured: Within three months after the intervention
Secondary outcomes (5)
BCS uptake rate
BC screening uptake rate within six months after the intervention
Measured: Six months after the intervention
Risk factors related to BCS non-adherence by interview
Risk factors associated with breast cancer screening non-adherence will be collected by focused group discussion
Measured: Six months after the intervention
Mammography results
Number of positive mammography results of subjects who completed mammography
Measured: Six months after the intervention
Mammograph breast biopsy rate
Uptake rate of subsequent breast biopsy for those with positive mammographic results
Measured: Six months after the intervention
Detection rate of breast cancer
Detection rate of breast cancer
Measured: Six months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Jul 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer PreventionStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to either join the whatsapp chatbot intervention and standard text reminder group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Yuen Tung Lam, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722469
- Sponsor's protocol ID
- 2024.527
- Acronym
- BCS
- Status last verified
- Dec 2024
- First submitted
- 21 Nov 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Still being decided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Evaluating a Mobile Messenger-initiated, Theory-based, Culturally Tailored, and Fully Automated Chatbot to Increase Breast Cancer Screening Uptake
- ClinicalTrials.gov ID
- NCT06722469
- Acronym / sponsor ID
- BCS / 2024.527
- Conditions
- Breast Cancer Prevention, Breast Cancer Risk
- Keywords
- breast cancer, automated chatbot, breast cancer screening, health belief model
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized to either join the whatsapp chatbot intervention and standard text reminder group.
| Arm | Type | Receives |
|---|---|---|
| WCI | Experimental | Other: WCIThe 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. |
| STR | No intervention | –A standard tet reminder will be sent regarding the breast cancer screening program |
Who may qualify
- Ages
- 44 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- asymptomatic Chinese Women
- 44-69 years old
- eligible to enroll in a government-subsidized risk-stratified BC screening program
- ability to read Chinese
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WCIThe 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. | Other | WCI |
Primary outcome
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.
5 secondary outcomes
BCS uptake rate
Time frame: Six months after the intervention
Risk factors related to BCS non-adherence by interview
Time frame: Six months after the intervention
Mammography results
Time frame: Six months after the intervention
Mammograph breast biopsy rate
Time frame: Six months after the intervention
Detection rate of breast cancer
Time frame: Six months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: Undecided. Still being decided
Related trials for Breast Cancer Prevention
RecruitingPhase 2
A Clinical Study on Prophylactic RespOnse To hEtrombopag for Secondary Prevention in Anti-Cancer Therapy-induced Thrombocytopeniae
Breast Cancer Patients at High Risk of Chemotherapy-induced Thrombocytopenia (CTIT)
RecruitingObservational study
Environmental Exposure Assessment in High-Risk and Early-Onset Breast Cancer Care
Breast Carcinoma
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
RecruitingPhase 2
PirfenidoneVsPlacebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following HFRT in Breast Cancer Patients
Acute Lung Injury, Prevention
RecruitingPhase 4
An Open-label, Single-arm Study of Prophylaxis for Datopotamab Deruxtecan (Dato-DXd) -Related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-small Cell Lung Cancer.
Stomatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing WCI in people with Breast Cancer Prevention and Breast Cancer Risk, run by Chinese University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Lam, PhD in Medical Science (852-26370428, thomaslam@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCS uptake rate (time frame: Within three months after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.