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

NCT ID: NCT06293508

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2024-10-04

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.

Conditions

Breast Neoplasm Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: DOUBLE

Study Groups

Control Arm

Participants do not receive any message throughout the study period.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Experimental Arm 1

Participants in this group will receive a message on a weekly basis throughout the intervention period, which is 6 months, via WhatsApp.

Group Type: EXPERIMENTAL

Standard Health Communication Intervention

Intervention Type: BEHAVIORAL

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.

Experimental Arm 2

Participants in this group will receive a message on a weekly basis throughout the intervention period, which is 6 months, via WhatsApp.

Group Type: EXPERIMENTAL

Behavioural Change Health Communication Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health, Malaysia

OTHER_GOV

Sponsor Role: collaborator

National University of Malaysia

OTHER

Sponsor Role: collaborator

Institute for Health Behavioral Research, Malaysia

UNKNOWN

Sponsor Role: collaborator

Clinical Research Centre, Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Nicholas Hing Yee Liang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicholas Yee Liang Hing, MSc

Role: PRINCIPAL_INVESTIGATOR

Institute for Clinical Research, National Institutes of Health, Malaysia

Locations

Institute for Clinical Research, National Institutes of Health, Malaysia

Shah Alam, Selangor, Malaysia

Countries

Malaysia

Other Identifiers

NMRR ID-22-02616-I2I

Identifier Type: -

Identifier Source: org_study_id