Effect of a mHealth Psycho-educational Intervention (mPEI) on Self-efficacy, Coping, and Psychological Distress Among Women Receiving Chemotherapy for Breast Cancer in Nigeria: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Change in self-efficacy
研究概览
简要总结
The research is studying the effect of a mHealth psychoeducational intervention on self-efficacy, coping and psychological distress of Nigerian women diagnosed with breast cancer receiving chemotherapy
The study is a two-arm assessor-blinded randomised controlled trial which will be conducted in two University Teaching Hospitals in Nigeria.
详细描述
Aim The study aims to develop and implement a culturally adapted mHealth psychoeducational intervention (mPEI) for Nigerian women diagnosed with breast cancer receiving chemotherapy.
Objectives
- To evaluate the effectiveness of the programme on self-efficacy (primary outcome), coping, symptom distress, anxiety, depression, and quality of life (secondary outcomes) among women with breast cancer receiving chemotherapy
- To explore the participants' experiences and feelings towards the intervention.
Hypothesis
It is hypothesised that participants who receive the mPEI program, when compared with the control group at baseline and immediately after the intervention, will demonstrate:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The research assistants who assess outcome data, data entry and analysis will be blinded to avoid the risk of assessor bias. The assistants will not participate in any other stage of implementing the program
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Include females who are:
- •newly diagnosed with breast cancer within the recent three months
- •currently receiving chemotherapy,
- •have access to a smartphone and internet,
- •are able to read and write in English,
- •are cognitively capable of completing the questionnaires,
- •consent to join the study.
排除标准
- •Include females:
- •with a concurrent physical or mental illness (as these might act as a confounder)
- •cognitively impaired
结局指标
主要结局
Change in self-efficacy
时间窗: Pre-intervention and immediately after the six weeks intervention
Self-efficacy for coping with cancer will be measured with the Cancer Behaviour Inventory-Brief Version (CBI-B). This is a 12-item instrument measuring confidence of individuals in performing activities that show how well they are coping with the demands of cancer and their treatment. Each item will be scored on a nine-point Likert scale with '1' meaning 'not at all confident' and '9' meaning 'totally confident'. The lowest score is 12 and the highest score is 108. Higher scores indicate greater self-efficacy in coping.
次要结局
- Change in Depression(Pre-intervention and immediately after the six weeks intervention)
- Change in Coping(Pre-intervention and immediately after the six weeks intervention)
- Change in Symptom Distress(Pre-intervention and immediately after the six weeks intervention)
- Change in Anxiety(Pre-intervention and immediately after the six weeks intervention)
- Change in Quality of Life(Pre-intervention and immediately after the six weeks intervention)
研究者
Akingbade Oluwadamilare
Principal Investigator
Chinese University of Hong Kong