A Randomized Controlled Trial to Increase Breast Cancer Screening Uptake

NCT06722469 | Not Yet Recruiting DMC

• 1 other identifier: 2024.527
• Study Type: interventional
• Target: 470
• Locations: 0 countries
• Sites: N/A

Brief 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%. 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.

Conditions

Breast Cancer Prevention; Breast Cancer Risk

Keywords

breast cancer; automated chatbot; breast cancer screening; health belief model

Outcome Measures

Primary Outcomes (1)

• 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.

  Within three months after the intervention

Secondary Outcomes (5)

• BCS uptake rate

  Six months after the intervention

• Risk factors related to BCS non-adherence by interview

  Six months after the intervention

• Mammography results

  Six months after the intervention

• Mammograph breast biopsy rate

  Six months after the intervention

• Detection rate of breast cancer

  Six months after the intervention

Study Arms (2)

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.

Other: WCI

STR

NO INTERVENTION

A standard tet reminder will be sent regarding the breast cancer screening program

Interventions

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.

WCI

Eligibility Criteria

• Age: 44 Years - 69 Years
• Gender Eligibility Details: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Thomas Lam, PhD in Medical Science

CONTACT

852-26370428; thomaslam@cuhk.edu.hk

Felix Sia, Master of Science

CONTACT

26370428; felixsia@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know what arm they are randomized into.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomized to either join the whatsapp chatbot intervention and standard text reminder group.

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: December 9, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 9, 2024

Record last verified: 2024-12