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TerminatedNCT06293508mBLISS-BUpdated Nov 12, 2024

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

An interventional study of Standard Health Communication Intervention and Behavioural Change Health Communication Intervention in Breast Neoplasm Female, sponsored by Clinical Research Centre, Malaysia. Terminated at 1 site in Malaysia. Open to female participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-12.

Sponsored by Clinical Research Centre, Malaysia · Not applicable, Interventional, and Screening

Why this study was terminated
Project was halted due to administrative complications arising while seeking for a vendor to assist with subject recruitment.
Phase
Not applicable
Study type
Interventional
Enrollment
1,180
Allocation
Randomized
Ages
40 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Neoplasm Female

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Keywords

  • mHealth
  • breast cancer screening
  • behaviour
  • health communication
  • randomised controlled trial
  • behaviour change communication
  • persuasive communication
  • social messaging
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 1,180 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Clinical Research Centre, Malaysia is the lead sponsor of 28 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
1,180 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • BehavioralStandard 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.

  • BehavioralBehavioural 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.

06

What researchers measure

Primary outcomes

  1. Breast cancer screening attendance (either clinical breast examination (CBE) or mammogram).

    Self-reported attendance of breast cancer screening

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

Secondary outcomes

  1. Health literacy level

    Scored via a validated instrument

    Time frame: At baseline

  2. Perception based on domains in Health Belief Model

    Scored via a validated revised Champion Health Belief Model Scale instrument

    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.

  3. Perceived acceptance and usefulness of health communication program

    Scored via a validated instrument

    Time frame: 3 months after 6 month intervention period has ended.

  4. Reasons behind participants not participating in breast cancer screening.

    Determined via a multiple choice question

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

07

Study locations

1 site
  • Institute for Clinical Research, National Institutes of Health, Malaysia
    Shah Alam, Selangor 40170, Malaysia
08

References and documents

Individual participant data

Plan to share: No — No plans to share IPD.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06293508
Lead sponsor
Clinical Research Centre, Malaysia
Collaborators
Ministry of Health, Malaysia, National University of Malaysia, Institute for Health Behavioral Research, Malaysia
Responsible party
Nicholas Hing Yee Liang (Principal Investigator, Clinical Research Centre, Malaysia) — Principal investigator
First posted
Mar 5, 2024
Start date
Apr 30, 2024
Primary completion
Oct 4, 2024
Completion
Oct 4, 2024
Last update
Nov 12, 2024

Study contacts

Nicholas Yee Liang Hing, MSc
principal investigator · Institute for Clinical Research, National Institutes of Health, Malaysia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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