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

Not Applicable

Terminated

• Conditions: Breast Neoplasm Female
• Interventions: Behavioral: Standard Health Communication Intervention; Behavioral: Behavioural Change Health Communication Intervention

• Registration Number: NCT06293508
• Lead Sponsor: Clinical Research Centre, Malaysia

Brief 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, a randomized controlled trial will be designed 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. The investigators 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-02-28
• Study First Submitted QC: 2024-02-28
• Study First Posted: 2024-03-05
• Study Start: 2024-04-30
• Primary Completion: 2024-10-04
• Study Completion: 2024-10-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-08
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Arm 1	Standard Health Communication Intervention	Participants in this group will receive a message on a weekly basis throughout the intervention period, which is 6 months, via WhatsApp.
Experimental Arm 2	Behavioural Change Health Communication Intervention	Participants in this group will receive a message on a weekly basis throughout the intervention period, which is 6 months, via WhatsApp.

Primary Outcome Measures

Name	Time	Method
Breast cancer screening attendance (either clinical breast examination (CBE) or mammogram).	2 time points: 3 months after 6 month intervention period has ended, and 6 months after 6 month intervention period has ended.	Self-reported attendance of breast cancer screening

Secondary Outcome Measures

Name	Time	Method
Reasons behind participants not participating in breast cancer screening.	2 time points: Baseline, and 3 months after 6 month intervention period has ended.	Determined via a multiple choice question
Perception based on domains in Health Belief Model	3 time points: Baseline, 3 months after 6 month intervention period has ended, and 6 months after 6 month intervention period has ended.	Scored via a validated revised Champion Health Belief Model Scale instrument
Perceived acceptance and usefulness of health communication program	3 months after 6 month intervention period has ended.	Scored via a validated instrument
Health literacy level	At baseline	Scored via a validated instrument

Trial Locations

Locations (1)

Institute for Clinical Research, National Institutes of Health, Malaysia; 🇲🇾 Shah Alam, Selangor, Malaysia