Mobile Medical Application on Adjuvant Therapy Compliance and Quality of Life in Patients With Early Breast Cancer: a Multicentric, Open-labeled, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Rate of compliance with adjuvant therapy
研究概览
简要总结
The goal of this multicentric randomized controlled clinical trial is to test the role of mobile medical application (APP) on adjuvant therapy compliance and quality of life (QoL) in patients with early breast cancer. Participants assigned to the Ruijin Breast Cancer APP (RJBC-APP) group can receive treatment reminders, matters needing attention as well as science knowledge and they can communicate with the medical staff during adjuvant treatments while follow-up can only be conducted in outpatient clinic for those in the Control group.
详细描述
Adjuvant treatments has significantly improved the prognosis of early breast cancer patients. However, previous studies suggested the existence of noncompliance to adjuvant therapies, which might cause detriments to disease outcomes. The goal of this multicentric randomized controlled clinical trial is to test the role of mobile medical application (APP) on adjuvant therapy compliance and quality of life (QoL) in patients with early breast cancer. Patients diagnosed with invasive breast cancers after surgery will be randomly assigned to the Ruijin Breast Cancer APP (RJBC-APP) group or the Control group. Those in the RJBC-APP group can receive treatment reminders, matters needing attention as well as science knowledge and they can communicate with the medical staff during adjuvant treatments while follow-up can only be conducted in outpatient clinic for those in the Control group. The primary endpoint is the rate of adjuvant therapy compliance at 12 months after randomization. Secondary endpoints consist of compliance rates at 3, 6, 24 months after randomization, QoL and cancer-related symptoms scores at 3, 6, 12, 24 months, disease-free survival (DFS) and overall survival (OS) at 60 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Females aged 18-70
- •Eastern Cooperative Oncology Group Performance Status Score 0-2
- •Breast cancer by pathology
- •Adjuvant therapy by multidisciplinary team
- •Written informed consent form
排除标准
- •Distant metastases at diagnosis
- •Unable to use a smartphone
结局指标
主要结局
Rate of compliance with adjuvant therapy
时间窗: 12 months after adjuvant therapy
Compliance is defined as completing the adjuvant therapy recommended by multidisciplinary team in terms of the type, dosage, date and course, and non-compliance is considered in the presence of any of the following cases: 1) the patient refuses to accept the recommended treatments, 2) the actual treatments are different from those recommended, 3) the patient dose not complete the full course of treatments, 4) the patient starts the treatment 7 days or more later than the established date, 5) the patient does not follow the recommended dose and intensity.
Overall Survival (OS)
时间窗: 60 months after adjuvant therapy
OS is calculated from the date of surgery to the date of death.
次要结局
- Rate of compliance with adjuvant therapy(3、6 and 24 months after adjuvant therapy)
- Quality of Life (QoL) Scale(3、6、12 and 24 months after adjuvant therapy)
- Cancer-related symptoms scores(3、6、12 and 24 months after adjuvant therapy)
- Disease-free Survival (DFS)(60 months after adjuvant therapy)
研究者
Kunwei Shen
Professor
Shanghai Jiao Tong University School of Medicine