Randomized Phase II Study to Evaluate Efficacy of Web-based Patient-reported Outcome (PRO) Application in Solid Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Rate of unplanned healthcare utilization per patient
研究概览
简要总结
This is a single-center, open-label, Phase 2 study to evaluate the feasibility of a mobile PRO and its efficacy in reducing unplanned healthcare utilization (unplanned outpatient visits, emergency department visits, and hospitalizations).
详细描述
The intervention lasted 12 weeks. Patients in the Mobile PRO group received instruction on symptom reporting and were asked to submit reports at baseline and at least once before each outpatient visit. Treating oncologist reviewed Mobile PRO entries during clinic visits and used the information in clinical decision-making; no automated alerts or additional staff-based interventions were implemented.
Usual-care patients did not use Mobile PRO; symptoms were assessed verbally during routine outpatient visits. AEs in both groups were graded using NCI-CTCAE version 5.0. All patients received chemotherapy according to institutional practice, including guideline-based antiemetic prophylaxis. Survival follow-up was conducted every 3 months after the 12-week intervention.
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
- •Age ≥19 years old
- •Histologically or cytologically confirmed solid cancer (clinical diagnosis accepted for hepatocellular carcinoma per the American Association for the Study of Liver Disease guidelines)
- •Receiving systemic therapy (cytotoxic, immunotherapy, targeted therapy, or combinations) as monotherapy or concurrent chemoradiotherapy
- •Able to use a smartphone or tablet independently or with caregiver assistance.
排除标准
- •Receiving third-line or later palliative systemic therapy
- •Inability to understand PROM content.
结局指标
主要结局
Rate of unplanned healthcare utilization per patient
时间窗: 12-week intervention period
the composite of unplanned outpatient visits, emergency departments, visits, or hospitalizations.
次要结局
- Impact on health-related QoL (HRQoL)(12-week intervention period)
- Progression-free survival(From the date of starting chemotherapy to the date of first documentation of progression or death (up to approximately 1 years))
- Overall survival(From the date of starting chemotherapy to the date of death (up to approximately 1 years))
- The proportions of individual components of unplanned healthcare use(12-week intervention period)
研究者
Sook Ryun Park
Associated Professor
Asan Medical Center