Clinical trial NCT06293508: mHealth Behavioural Intervention to Increase Breast Cancer Screening Rates Among Members of the Public
Official title: mHealth Behavioural Intervention to Increase Breast Cancer Screening Rates Among Members of the Public
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Neoplasm Female
Keywords: mHealth
breast cancer screening
behaviour
health communication
randomised controlled trial
behaviour change communication
persuasive communication
social messaging
Lead sponsor: Clinical Research Centre, Malaysia
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Malaysia
name: National University of Malaysia
name: Institute for Health Behavioral Research, Malaysia
First posted: 2024-03-05
Enrollment: 1180
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Breast cancer screening attendance (either clinical breast examination (CBE) or mammogram).
timeFrame: 2 time points: 3 months after 6 month intervention period has ended, and 6 months after 6 month intervention period has ended.
Secondary outcomes:
measure: Health literacy level
timeFrame: At baseline
measure: Perception based on domains in Health Belief Model
timeFrame: 3 time points: Baseline, 3 months after 6 month intervention period has ended, and 6 months after 6 month intervention period has ended.
measure: Perceived acceptance and usefulness of health communication program
timeFrame: 3 months after 6 month intervention period has ended.
measure: Reasons behind participants not participating in breast cancer screening.
timeFrame: 2 time points: Baseline, and 3 months after 6 month intervention period has ended.
Other outcomes:
Locations:
city: Shah Alam
country: Malaysia
facility: Institute for Clinical Research, National Institutes of Health, Malaysia
state: Selangor
Study officials:
affiliation: Institute for Clinical Research, National Institutes of Health, Malaysia
name: Nicholas Yee Liang Hing, MSc
role: PRINCIPAL_INVESTIGATOR
References: