Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma: The CANIQOL Multicentre Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 83
- 试验地点
- 19
- 主要终点
- Rate of patients with adjustment of treatments management
研究概览
简要总结
The aim of the study is to evaluate the impact of digital monitoring of self-reported symptoms (PROs) on the adjustment of treatment management in patients treated with cabozantinib plus nivolumab for advanced clear cell renal cell carcinoma (RCC) in real life during the first 3 months of combined treatment
详细描述
Patients receive the combination of Cabozantinib and Nivolumab as indicated in the label.
During this combined treatment, the digital monitoring system is used to collect weekly data on treatment tolerance, based on patient reports.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient older than 18 years
- •Diagnosis of advanced/metastatic Renal Cell Carcinoma (RCC) with a clear-cell component
- •No prior systemic treatment for RCC
- •Physician-initiated decision prior to study enrollment to treat with cabozantinib and nivolumab in combination, in first line for advanced/metastatic RCC, according to approved local labels
- •Female subjects of childbearing potential must not be pregnant at screening and during treatment by Cabozantinib and Nivolumab. Effective methods of contraception must be used throughout the course of treatment and for at least 5 months after the end of treatment. Sexually active fertile subjects and their partners must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the study and 5 months after the last dose of study treatment, even if oral contraceptives are also used.
- •Subject affiliated to an appropriate social security system
- •Patient has signed informed consents obtained before any trial related activities and according to local guidelines
排除标准
- •Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
- •Current participation in another clinical study and/or in an investigational program with any intervention that could possibly interfere with the treatment and impact this study
- •Patient with history of allergy or hypersensitivity to components of the study drugs
- •Patient with contraindication to the study drugs
- •Pregnant or lactating woman
- •Patient unable to use digital tools
- •Patient deprived of liberty or placed under the authority of a tutor
- •Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
研究组 & 干预措施
Digital monitoring under Cabozantinib and nivolumab treatments
During this combined treatment, the digital monitoring system is used to collect weekly data on treatment tolerance by patient self-report.
The digital telemonitoring platform is used to facilitate the monitoring of signs and symptoms of treatment-specific Adverse Events.
The platform integrates an algorithm to define patient risk based on responses to data collected on platform.
The self-reported information on the mobile digital device allows to "classify" patients ("correct", "compromised", "to be monitored", or "critical) and to create some alerts.
Some actions may be undertaken depending on these alerts, with adjustments of the management of treatments
干预措施: cabozantinib and nivolumab (Drug)
结局指标
主要结局
Rate of patients with adjustment of treatments management
时间窗: within the first 3 months of the combined treatment (cabozantinib and nivolumab)
rate of patients with adjustment of treatments management including any unplanned action guided by weekly digital monitoring of self-reported symptoms: anticipated consultation, anticipated phone follow-up, anticipated advices, treatment discontinuation, hospitalization within the first 3 months of the combined treatment
次要结局
- - To evaluate the improvement of self-reported symptoms after adjustment of the combined treatment(during the first 3 months of the combination (cabozantinib and nivolumab))
- - To characterize and evaluate regular follow-up of patients self-reported fatigue(During the first 6 months of combination (cabozantinib and nivolumab))
- - To have a longitudinal assessment of general health-related quality of life (QoL)(During the first 6 months of combination (cabozantinib and nivolumab))
- - To assess the feasibility of regular follow-up of PROs in real life(At 3 and 6 months after initiation of combination (cabozantinib and nivolumab))
- - To characterize and describe warning adverse reactions(During the first 6 months of the combination (cabozantinib and nivolumab))
- - To characterize alerts issued by digital monitoring(During the first 6 months of the combination (cabozantinib and nivolumab))
- To have a longitudinal assessment of anxiety/depression and pain(During the first 6 months of combination (cabozantinib and nivolumab))
- To characterize alerts issued by digital monitoring(During the first 6 months of combination (cabozantinib and nivolumab))
- - The evolution of self-reported symptoms(during the first 6 months of the combination (cabozantinb and nivolumab))
- - The evolution of self-reported symptoms(during the first 6 months of the combination (cabozantinb and nivolumab))
- - To evaluate the improvement of self-reported symptoms after adjustment of the combined treatment(during the first 3 months of the combination (cabozantinib and nivolumab))
- - To characterize and evaluate regular follow-up of patients self-reported fatigue(During the first 6 months of combination (cabozantinib and nivolumab))
- - To have a longitudinal assessment of general health-related quality of life (QoL)(During the first 6 months of combination (cabozantinib and nivolumab))
- - To assess the feasibility of regular follow-up of PROs in real life(At 3 and 6 months after initiation of combination (cabozantinib and nivolumab))
- - To characterize and describe warning adverse reactions(During the first 6 months of the combination (cabozantinib and nivolumab))
- - To characterize alerts issued by digital monitoring(During the first 6 months of the combination (cabozantinib and nivolumab))
- To have a longitudinal assessment of anxiety/depression and pain(During the first 6 months of combination (cabozantinib and nivolumab))
- To characterize alerts issued by digital monitoring(During the first 6 months of combination (cabozantinib and nivolumab))