Non-interventional and Longitudinal Study to Evaluate a List of Anticancer Drugs Under Real Conditions of Use and Measure the Quality of Life of Patients Treated at Rafaël Institute
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- incidence of serious adverse events
研究概览
简要总结
Currently, aspects related to the effects of anticancer treatments and the quality of life of patients and their needs are still poorly documented at the Rafael Institute. Thus this study will meet a dual objective: (1) the establishment of a registry to collect data on the safety and effectiveness of innovative and expensive anticancer drugs when administered in real life and (2) a measurement quantitative quality of life of patients treated with these drugs.
详细描述
In France, the promotion of more patient-centered medicine is among the priorities identified by the High Authority for Health in its 2024 strategic project. The patient-centered approach is based on a partnership relationship with the patient, their loved ones, and the healthcare professional or a multi-professional team to built together the best option of care.
In this approach, the Rafael Institute was created with the objective of caring for people and not simply pathologies. Initiated around the problem of cancer and the harmful effects of its treatments, the Rafaël Institute offers personalisation of care and continuity of care over time by providing monitoring and support to the patient by a multi-professional and multidisciplinary team. Thus, maintaining quality of life constitutes one of the objectives of the therapeutic management of patients with cancer.
Although modern oncological treatments have today enabled real advances on the biomedical level, they often have side effects that must be taken into account for the overall assessment and management of patients. Although most anticancer therapies have a negative impact on the patient's quality of life, this does not always reflect the occurrence of toxicity.
Since the 1990s, quality of life has been strongly associated with survival. Patients with high overall quality of life live significantly longer than patients with low overall quality of life.
The relationship between symptoms, their intensity and quality of life is essential to study to understand the perceived impact of treatments and optimize their use in daily practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age equal to or greater than 18 years (adult)
- •Patients treated with an anticancer drug included in the list of innovative/expensive therapies (protocol appendix)
- •Patients benefiting from non-pharmacological treatment at the Rafael Institute
- •Who understands the French language
排除标准
- •< 18 years old
- •Patient deprived of liberty, under guardianship or unable to give consent
结局指标
主要结局
incidence of serious adverse events
时间窗: up to 36 months
graded according to NCI CTCAE v5.0
progression free survival
时间窗: Until progression or death, assessed up to 36 months
PFS is defined as the time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first.
incidence of adverse events
时间窗: up to 36 months
graded according to NCI CTCAE v5.0
overall survival
时间窗: Until death, assessed up to 36 months
OS is defined as the time from the starting date of study drug to the date of death due to any cause.
次要结局
- Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire Core 30 (QLQ-C30) Score(every 6 months and up to 36 months)
- change from baseline in quality of life measured with the EQ5D5L questionnaire(every 6 months and up to 36 months)