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临床试验/NCT06293508
NCT06293508终止不适用

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

Clinical Research Centre, Malaysia2 个研究点 分布在 1 个国家目标入组 1,180 人开始时间: 2024年4月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
1,180
试验地点
2
主要终点
Breast cancer screening attendance (either clinical breast examination (CBE) or mammogram).

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Standard Health Communication Intervention (Behavioral)

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.

干预措施: Behavioural Change Health Communication Intervention (Behavioral)

结局指标

主要结局

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

时间窗: 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

次要结局

  • Reasons behind participants not participating in breast cancer screening.(2 time points: Baseline, and 3 months after 6 month intervention period has ended.)
  • 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.)
  • Health literacy level(At baseline)

研究者

发起方
Clinical Research Centre, Malaysia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicholas Hing Yee Liang

Principal Investigator

Clinical Research Centre, Malaysia

研究点 (2)

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