mHealth Behavioural Intervention to Increase Breast Cancer Screening Rates Among Members of the Public

Breast Neoplasm Female Clinical Trial

— mBLISS-B  

Official title:

mHealth Behavioural Intervention to Increase Breast Cancer Screening Rates Among Members of the Public

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06293508
• Other study ID #: NMRR ID-22-02616-I2I
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: July 2025

Study information

• Verified date: February 2024
• Source: Clinical Research Centre, Malaysia
• Contact: Nicholas Yee Liang Hing, MSc
• Phone: +60333627700
• Email: nicholas.hingyl[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Late-stage presentation of breast cancer cases are on the rise in Malaysia. Encouraging breast screening practices can assist in early breast cancer detection. Literature has proven that behavior interventions in the form of behavior change health communication using social messaging applications is a viable strategy and potentially effective at motivating breast cancer screening among the public. Such studies are scarce in the South East Asian region, particularly in Malaysia, which is the prime motivation for the current study,

Based on this promising prospect, we designed a randomized controlled trial to study the effects of applying persuasive health communication materials to initiate behavior change among a group of Malaysian women. Materials are delivered in the form of a health communication program over a social messaging application to promote breast cancer screening practices, which is either a clinical breast examination, or a mammogram. We hypothesize that Malaysian women who are exposed to such materials that are designed based on behavior science and behavior change principles will be nudged and hence more likely to attend breast cancer screening compared to a control group.

Description:

This study involves a randomized controlled trial to asses the effectiveness of a health communication program using specifically designed materials using behavior science and behavior change principles. Materials were designed based on findings derived from a scoping review and interviewing Malaysian women through a series of qualitative interviews to determine the barriers and facilitators of attending breast cancer screening. The interview also investigated women's preferences for certain characteristics in a health message and health communication program that would motivate them to attend screening.

Participants in the main experimental group will be compared with a control group, and another group which undergoes a standard health communication program.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1180
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

1. Malaysian women aged 40 years and above

2. Possess a smartphone with the predetermined social messaging application (derived from Phase 1 of study) installed.

3. Have not been diagnosed with cancer before.

Exclusion Criteria:

1. Underwent Clinical Breast Examination in the past 12 months.

2. Mammogram screening in the past 2 years.

3. Subjects who are deemed to have cognitive impairment and unable to provide consent to the study.

Related Conditions & MeSH terms

• Breast Neoplasm Female
• Breast Neoplasms

Intervention

Behavioral:
• Standard Health Communication Intervention
Participants in this group will receive links and materials related to breast cancer screening from official sources (e.g. MOH, Non-governmental organizations (NGOs), etc.) that is already readily available and accessible by the Malaysian public. Frequency, duration, and platform of dissemination will be based on findings from Phase 1 of this study.
• Behavioural Change Health Communication Intervention
Participants receive health communication materials designed using persuasive behavioural change communication principles and behavior science to promote breast cancer screening. Frequency, duration, and platform of dissemination will be based on findings from Phase 1 of this study.

Locations

Country	Name	City	State
Malaysia	Institute for Clinical Research, National Institutes of Health, Malaysia	Shah Alam	Selangor

Sponsors (4)

Lead Sponsor	Collaborator
Clinical Research Centre, Malaysia	Institute for Health Behavioral Research, Malaysia, Ministry of Health, Malaysia, National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast cancer screening attendance (either clinical breast examination (CBE) or mammogram).	Self-reported attendance of breast cancer screening	2 time points: 3 months after 6 month intervention period has ended, and 6 months after 6 month intervention period has ended.
Secondary	Health literacy level	Scored via a validated instrument	At baseline
Secondary	Perception based on domains in Health Belief Model	Scored via a validated revised Champion Health Belief Model Scale instrument	3 time points: Baseline, 3 months after 6 month intervention period has ended, and 6 months after 6 month intervention period has ended.
Secondary	Perceived acceptance and usefulness of health communication program	Scored via a validated instrument	3 months after 6 month intervention period has ended.
Secondary	Reasons behind participants not participating in breast cancer screening.	Determined via a multiple choice question	2 time points: Baseline, and 3 months after 6 month intervention period has ended.