Impact of a Process Optimizing the Decision to Continue or Stop Cancer Treatments in Patients With Advanced Non-small Cell Lung Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 364
- 试验地点
- 48
- 主要终点
- Percentage of patients receiving systemic anticancer treatment in their last days of life
研究概览
简要总结
Sequential comparative prospective interventional study evaluating the impact of the use of an optimization device of the decision of cancer treatment on aggressiveness of end of life care. Comparison between a first period, period (A), of care as usual and a second period, period (B), of systematic and iterative use of a device for optimizing the decision to continue an anti-cancer treatment.
详细描述
We propose to study the optimization of this decision process in an advanced Non-Small-Cell Lung Carcinoma (NSCLC) population, with a Performance Status (PS) ≥ 2 (median survival of approximately 3 months) piloting iteratively (before each decision to continue treatment) a process consisting of an evaluation framework (30 items to be answered by the oncologist with the patient), consolidating:
- clinical parameters;
- doctors' expectations regarding the continuation of anticancer treatment;
- patient expectations and preferences;
- the possibility of referring the patient to a supportive care specialist and strengthening home care.
The process triggers a dialogue between the patient and the oncologist, based on facts and seeks objectivity, ultimately allowing a shared decision.
In this prospective comparative study, the rate of systemic oncological treatment during the last month of life will be measured consecutively, over a period of usual management, followed by a period of systematic application of a process of optimization of the medical decision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Histologically or cytologically proven non-small-cell lung carcinoma (NSCLC) including NSCLC with oncogene addiction.
- •Stage IV or IIB/IIIC non irradiable (8th classification TNM, UICC 2015)
- •Patient having completed at least one line of chemotherapy in the context of metastatic disease (or in the context of locoregional disease if the last chemotherapy was less than 6 months ago).
- •ECOG Performance Status ≥
- •Written informed consent.
- •Patient capable, according to the investigator, to comply with the requirements of the study.
排除标准
- •Small Cell Lung Cancer (including mixed forms).
- •Patient with NSCLC for whom a decision has already been made to permanently discontinue all systemic cancer treatment.
- •Impossible follow up for geographical, social or psychological reason.
- •Inability to answer a questionnaire (language or neurological barrier).
- •Patient under guardianship.
- •Patient being treated in a therapeutic trial.
- •Patient not covered by social security. -
结局指标
主要结局
Percentage of patients receiving systemic anticancer treatment in their last days of life
时间窗: 24 months
Comparison of the percentage of patients receiving systemic anticancer treatment in their last 30 days of life during each period
次要结局
- Number of emergency room visits(24 months)
- Overall survival (OS)(24 months)
- Use of supportive care(24 months)
- Percentage of immunotherapy and of Tyrosine kinase inhibitor(24 months)
- Percentage of chemotherapy(24 months)
- Percentage of initiation of a new line of chemotherapy(24 months)
- Percentage of initiation of Tyrosine kinase inhibitor or immunotherapy(24 months)
- Quality of life using QLQ-C15-PAL EORTC (European Organization for Research and Treatment of Cancer) and anxiety with HAD (Hospital Anxiety and Depression) questionnaire(24 months)