The Evaluation of Intelligence Breast Cancer Self-Management Mobile Care Application Intervention in the Quality of Life for Newly Diagnosed Non-metastatic Breast Cancer Women: Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Baseline EORTC QLQ-C30
研究概览
简要总结
The aim of this study was to investigate the quality of life (QoL) for women with breast cancer in Taiwan after using the BCSMS App.
详细描述
After receiving their first diagnosis of breast cancer, women with stage 0 to III were randomized into intervention and control groups. Intervention group subjects used BCSMS App and the control group subjects received usual care. Two questionnaires: EORTC QLQ-C30 and EORTC QLQ-BR 23 were distributed to subjects in both arms at baseline and at 1.5 and 3 months. All evaluations were anonymous.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •first diagnosis of breast cancer with stage 0 to III in past year.
- •aged 20 to 65 years
- •had an Android/iOS smartphone;
- •able to read and write in Chinese;
- •willing to participate in the study and provide informed consent.
排除标准
- •not matched to inclusion criteria
- •mental illness
- •serious illness and life-threatening
结局指标
主要结局
Baseline EORTC QLQ-C30
时间窗: Baseline
Baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life -Core 30 (version 3). The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
Change of EORTC QLQ-C30 at 3 month
时间窗: the 3rd month
Change from baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life -Core 30 (version 3) to the 3rd month. The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
Change of EORTC QLQ-C30 at 1.5 month
时间窗: 1.5 month
Change from baseline Taiwan Chinese version of the European Organisation for Research and Treatment of Cancer Quality of Life -Core 30 (version 3) to 1.5 month.The minimum and maximum values are 0 and 100, and higher scores mean a better outcome.
次要结局
- Baseline EORTC QLQ-BR23(Baseline)
- Change of EORTC QLQ-BR23 at 1.5 month(1.5 month)
- Change of EORTC QLQ-BR23 at 3 month(the 3rd month)
研究者
I-Ching Hou
Assistant Professor
National Yang Ming Chiao Tung University