NCT06230445招募中3 期
A Phase 3, Randomized, Open-label Trial of Digital Therapeutic vs Regular Follow-up in Whole Process Management of Lung Cancer
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2023年6月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- The quality of life after 6 months follow-up
研究概览
简要总结
This trial will randomize patients into two groups, the treatment group will use the digital therapeutic application named 'UHealth' for the whole process management and the control group will use regular follow-up. The trial aims to look into the difference between quality of life, anxiety/depression index, emergency treatment times, hospital admission rate, treatment compliance, OS, DFS and follow-up cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically or cytologically confirmed lung cancer;
- •Patients have received surgery, neoadjuvant therapy, adjuvant therapy, radiotherapy or other chemotherapy, such as cytotoxic chemotherapy, targeted therapy and immunotherapy;
- •ECOG (Performance status) 0-1;
- •Patients aged > 18 years and < 70 years;
- •The patients themselves or their family members are familiar with mobile and internet;
排除标准
- •Patients have disease progression in the screening period;
- •Patients with symptomatic brain metastasis;
- •Patients with dementia, schizophrenia or other psychological diseases that may affect the cognitive behavior;
- •Other medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information;
- •Women who are pregnant or in the period of breastfeeding.
结局指标
主要结局
The quality of life after 6 months follow-up
时间窗: From enrollment to 6 months after follow-up
The evaluation of quality of life is based on FACT questionnaire (Version 4.0)
次要结局
- The physical fitness score at the time of tumor progression(From enrollment to the time of tumor progression (up to 72 months))
- The frequency of rehospitalization(24 months after enrollment)
- The compliance of follow-up(24 months after enrollment)
- Disease-free survival(24 months after enrollment)
- Overall survival(24 months after enrollment)
- The score of anxiety/depression after 6 months follow-up(From enrollment to 6 months after follow-up)
- The frequency of emergency treatment(24 months after enrollment)
研究者
Hao Long
Prof.
Sun Yat-sen University
研究点 (1)
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