NCT05931445进行中（未招募）不适用
Multicenter, Open-label, Randomized, Controlled Study to Test the Utility of Electronic Patient-reported Outcome (ePRO) Monitoring in Patients With Unresectable Advanced Cancers or Metastatic/Recurrent Solid Tumors
Comprehensive Support Project for Oncology Research2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2021年1月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- HRQoL EORTC Quality of Life of Cancer Patients (QLQ-C30) global health status score
研究概览
简要总结
This is a multicenter, open-label, randomized, controlled study to test the hypothesis that ePRO monitoring added to usual care helps prolong OS or maintain and improve HRQoL in patients with unresectable advanced cancers or metastatic/recurrent solid tumors receiving systemic drug therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unresectable, advanced, metastasized, or relapsed solid tumors (Breast Cancer, Lung Cancer, Colorectal Cancer, Liver Cancer, Stomach Cancer, Endometrial Cancer, Ovarian Cancer, or Squamous Cell Carcinoma of the Head and Neck)
- •Expected to be able to undergo treatment or observation for at least 6 months at the study site
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2
- •Receiving systemic anticancer mono- or combination pharmacotherapy (e.g., cytotoxic anticancer agents, molecularly targeted drugs, and immune checkpoint inhibitors) at enrollment or scheduled to begin such therapy within 1 month from the date of enrollment (In principle, patients should be receiving pharmacotherapy on an out-patient basis.)
- •Capable of using electronic device (includes cases needing some assistance)
- •Aged 18 years or older at informed consent
- •Written consent for the study personally obtained from the subject
排除标准
- •Has undergone four or more regimens of pharmacotherapy for advanced, metastasized, or relapsed solid tumors*Notes 1, 2
- •Currently participating in a study where PRO is tracked and the results are passed on to a physician
- •The following are exclusion criteria for individual types of cancer 1) Breast cancer
- •Scheduled to receive or currently receiving endocrine therapy (including endocrine therapy in combination with other agents) for hormone receptor-positive breast cancer
- •Scheduled to receive or currently receiving first regimen of anti-HER2 therapy for HER2-positive disease 2) Liver cancer
- •Hepatic function of Child-Pugh B/C
- •Undergoing or scheduled to undergo radiation therapy for curative purposes
- •Deemed otherwise unsuitable for the study by the investigator or sub-investigator
- •If the disease has relapsed during perioperative adjuvant chemotherapy or within 24 weeks after adjuvant chemotherapy, the adjuvant chemotherapy will be considered as the first regimen of adjuvant chemotherapy.
- •Does not include endocrine therapy for breast cancer.
结局指标
主要结局
HRQoL EORTC Quality of Life of Cancer Patients (QLQ-C30) global health status score
时间窗: At enrollment and week 4,8,12,16,20 and 24 after enrollment
Overall Survival (OS)
时间窗: After enrollment to death from any cause (up to 57 months)
次要结局
- HRQoL EORTC Quality of Life of Cancer Patients (QLQ-C30) domain score(At enrollment and week 4,8,12,16,20 and 24 after enrollment)
- Total number of drug regiments(After enrollment up to 57 months)
- HRQoL EQ-5D-5L index score(At enrollment and every 4 weeks after enrollment up to 57 months)
- Time from last completion of drug therapy to death(Time from last completion of drug therapy to death from any cause (up to 57 months))
- At-home mortality rate(After enrollment to death from any cause (up to 57 months))
- Quality-adjusted life year (QALY) score(After enrollment to death from any cause (up to 57 months))
- Relative Dose Intensity (RDI)(After enrollment up to 24 weeks)
- Communication between patients and healthcare providers (EORTC QLQ-COMU26 score)(At enrollment and week 24 after enrollment)
- Number of unscheduled hospital visits during drug therapy(After enrollment up to 24 weeks)
- Incremental Cost-Effectiveness Ratio (ICER)(After enrollment up to 57 months)
研究者
研究点 (2)
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