mHealth Behavioural Intervention to Increase Breast Cancer Screening Rates Among Members of the Public (mBLISS-B)

February 28, 2024 updated by: Nicholas Hing Yee Liang, Clinical Research Centre, Malaysia

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Malaysia
    • Selangor
      • Shah Alam, Selangor, Malaysia, 40170
        • Institute for Clinical Research, National Institutes of Health, Malaysia
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Arm
Participants do not receive any message throughout the study period.
Experimental: 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.
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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breast cancer screening attendance (either clinical breast examination (CBE) or mammogram).
Time Frame: 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
2 time points: 3 months after 6 month intervention period has ended, and 6 months after 6 month intervention period has ended.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Research Centre, Malaysia

Collaborators

Ministry of Health, Malaysia
National University of Malaysia
Institute for Health Behavioral Research, Malaysia

Investigators

  • Principal Investigator: Nicholas Yee Liang Hing, MSc, Institute for Clinical Research, National Institutes of Health, Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Estimated)

March 5, 2024

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRR ID-22-02616-I2I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plans to share IPD.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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