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

NCT06293508 | Terminated

• 1 other identifier: NMRR ID-22-02616-I2I
• Study Type: interventional
• Target: 1,180
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm Female

Keywords

mHealth; breast cancer screening; behaviour; health communication; randomised controlled trial; behaviour change communication; persuasive communication; social messaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Health literacy level

  At baseline

• 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.

• Perceived acceptance and usefulness of health communication program

  3 months after 6 month intervention period has ended.

• Reasons behind participants not participating in breast cancer screening.

  2 time points: Baseline, and 3 months after 6 month intervention period has ended.

Study Arms (3)

Control Arm

NO INTERVENTION

Participants do not receive any message throughout the study period.

Experimental Arm 1

EXPERIMENTAL

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

Experimental Arm 2

EXPERIMENTAL

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

Interventions

Standard Health Communication Intervention 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 1

Behavioural Change Health Communication Intervention 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.

Experimental Arm 2

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Malaysian women aged 40 years and above
• Possess a smartphone with the predetermined social messaging application (derived from Phase 1 of study) installed.
• Have not been diagnosed with cancer before.

You may not qualify if:

• Underwent Clinical Breast Examination in the past 12 months.
• Mammogram screening in the past 2 years.
• Subjects who are deemed to have cognitive impairment and unable to provide consent to the study.

Sponsors & Collaborators

• Clinical Research Centre, Malaysia: lead
• Ministry of Health, Malaysia: collaborator
• National University of Malaysia: collaborator
• Institute for Health Behavioral Research, Malaysia: collaborator

Study Sites (1)

Institute for Clinical Research, National Institutes of Health, Malaysia

Shah Alam, Selangor, 40170, Malaysia

Location

MeSH Terms

Conditions

Behavior

Study Officials

• Nicholas Yee Liang Hing, MSc

  Institute for Clinical Research, National Institutes of Health, Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 5, 2024
• Study Start: April 30, 2024
• Primary Completion: October 4, 2024
• Study Completion: October 4, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)