Pilot Study of the eHealth Application "Cancer Patients Better Life Experience" (CAPABLE) - Italy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change in health-related QoL outcomes in RCC patients
研究概览
简要总结
The purpose of the CAPABLE study is to compare health-related quality of life in renal cell carcinoma patients who use or do not use a mobile-based application to monitor adverse events for cancer treatment at home. As secondary objectives, the study investigates the usability of the system and its generalizability to other cancer types
详细描述
The study is designed as a prospectively enrolling, quasi-experimental cohort study in cancer patients, eligible for systemic treatment.
The CAPABLE cohort will receive the smartphone application and a multi-sensorial smartwatch (ASUS VivoWatch 5 HC-B05). Patients will be asked to use the system for at least 6 months after enrollment. If, after 6 months, a patient wants to keep using the system, he will be allowed to do so, until the end of the study. Questionnaires on health-related quality of life will be administered to the patients on baseline (T0) and every three months (T1 and T2). Lost to follow-up data will be included in intention-to-treat analysis. Qualitative and quantitative user experience studies will be done at enrollment, after 3 months and at the end of the follow-up period with the CAPABLE system. Results of this interventional study will be compared with a control cohort consisting of renal cell carcinoma patients, recruited in 2021 with the same inclusion criteria as this study population, but receiving standard care (ICSM CE number 2546, dated 13/04/2021 and amended on 09/02/2022).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Adults (age >=18 years)
- •Sufficient understanding of the Italian language
- •Patients or their caregiver (upon patient's consent) can use a smartphone
- •Histologically or cytologically confirmed diagnosis of RCC, lung, breast, thyroid o head and neck cancer
- •Candidate to systemic treatment (targeted agents, immune checkpoint inhibitors, or a combination of the two)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the start of the treatment.
排除标准
- •Recruitment and consent denial
- •Not able of understanding and complying with the protocol requirements (including basic technological abilities)
- •Given the fact that each subject involved in the clinical study must be able to understand and sign the informed consent presented by the researcher, lack of this capability represents a specific exclusion criterion in the study protocol.
结局指标
主要结局
Change in health-related QoL outcomes in RCC patients
时间窗: 6 months after the enrollment
The primary objective of this study is to investigate whether HRQoL of RCC patients eligible for systemic treatment can be improved by a patient-centred mobile coaching- and monitoring system
次要结局
- User experience of the CAPABLE system in other cancer types patients(6 months after the enrollment)
- User experience of the CAPABLE system in RCC patients(6 months after the enrollment)