Evaluation of the Effectiveness of Managing Chemotherapy Side Effects Using ePRO and a Standardized Telenursing Program for Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 414
- 试验地点
- 5
- 主要终点
- Quality of life Measured by EORTC QLQ-C30
研究概览
简要总结
This is a multicenter randomized controlled clinical trial designed to evaluate the clinical efficacy and cost-effectiveness of a digital health platform that integrates a symptom reporting and management software with a standardized telenursing program, allowing cancer patients to actively monitor, report, and self-manage chemotherapy-related adverse effects.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or older
- •Diagnosed with early or advanced gastric, lung, breast, or colon cancer
- •Starting first-cycle chemotherapy with a new anticancer agent
- •Able to use a smartphone without difficulty
- •Willing to provide informed consent to participate in the study
排除标准
- •Individuals who have difficulty communicating due to cognitive impairment, visual impairment, hearing impairment, or other reasons
- •Individuals who cannot read, write, or understand Korean
- •Other individuals deemed inappropriate for participation by the investigators
研究组 & 干预措施
Standard Care Group
Standard care group is the control group, receiving standard care only without using Smart Cancer Care Plus or standardized telenursing.
ePRO Group
ePRO group is the experimental group, using Smart Cancer Care Plus without standardized telenursing.
干预措施: Smart Cancer Care Plus (Other)
ePRO + Telenursing Group
ePRO + Telenursing group is the experimental group, using Smart Cancer Care Plus in combination with standardized telenursing.
干预措施: Standardized Telenursing (Other)
ePRO + Telenursing Group
ePRO + Telenursing group is the experimental group, using Smart Cancer Care Plus in combination with standardized telenursing.
干预措施: Smart Cancer Care Plus (Other)
结局指标
主要结局
Quality of life Measured by EORTC QLQ-C30
时间窗: 12 weeks
Quality of life will be assessed using the Global Health Status/Quality of Life scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The score for the Global Health Status/Quality of Life scale ranges from 0 to 100, with higher scores indicating better quality of life.
次要结局
- Self-management, which will be assessed using the SECD-6-K(6 months)
- Self-rated overall health, which will be assessed using EQ-5D-VAS(6 months)
- Adherence to ePROSW(6 months)
- Chemotherapy Adherence(6 months)
- Healthcare Utilization(6 months)
- Functional status, which will be assessed using EORTC-QLQ-C30(6 months)
- Symptom severity, which will be assessed using EORTC-QLQ-C30(6 months)
- Satisfaction, which will be assessed using system usability scale(6 months)
研究者
Koh Su-Jin
Professor
Ulsan University Hospital