An Innovative Smartphone Application for Adverse Event Management During Breast Cancer Adjuvant Chemotherapy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 108
- 主要终点
- Change from baseline quality of life scores at 4 months
研究概览
简要总结
The aim of this study is to evaluate benefits of the app in breast cancer patients receiving the docetaxel, doxorubicin, and cyclophosphamide (TAC) chemotherapy. The investigators hypothesized that the addition of the app to conventional adverse event management would increase quality of life (QoL) scores and reduce adverse events.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pathological diagnosis of invasive breast cancer
- •breast surgery within the past 2-8 weeks
- •adult female
- •must be able to use mobile phones
- •speak and write Chinese fluently to sign the informed consent
排除标准
- •severe comorbidity that interferes with outcome evaluation
- •insufficient Chinese language skills
- •inability to use mobile phones
- •cognitive disability to give informed consent
研究组 & 干预措施
The intervention group
The intervention group will receive conventional adverse event management and have access to the smartphone app during chemotherapy.
干预措施: use of a smartphone app for adverse event management (Other)
The intervention group
The intervention group will receive conventional adverse event management and have access to the smartphone app during chemotherapy.
干预措施: conventional adverse event management (Other)
The control group
The control group will receive conventional adverse event management during chemotherapy. Chemotherapy-related adverse events in the control group will be managed with symptomatic treatment, dietary and lifestyle prescription according to the doctors' clinical experience.
干预措施: conventional adverse event management (Other)
结局指标
主要结局
Change from baseline quality of life scores at 4 months
时间窗: 1 day before the first cycle, and 4 months after the first cycle (each cycle is 21 days)
Quality of life scores will be assessed using the simplified Chinese version of the Organization for Research and Treatment of Cancer (EORTC QLQ-C30, version 3).
次要结局
- Incidence and severity of 12 common adverse events(4 months after the first cycle (each cycle is 21 days))