Long-Terms Responders in Metastatic Lung Cancer: Better Understanding for Better Management (LUNGEVITY STUDY)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 91
- 主要终点
- Baseline Clinical Characteristics
研究概览
简要总结
The goal of this observational study is to identify and describe the clinical characteristics, health status, socio-economic impacts and quality of life of patients alive for three years after diagnosis of metastatic Lung cancer and no longer receiving cytotoxic chemotherapy. The main question is to identify the needs of these patients in terms of health status (impact of cancer treatments, incidence of new diseases, cardiovascular, diabetes, second cancers), socio-economic aspects, quality of life and return to employment.
Participants will be asked to answer quality of life questionnaires at the time of inclusion and 6 and 12 months after inclusion and then, every year up to 5 years in this study.
They will be followed regularly, in consultations, according to the usual practices of the physicians in each participating center.
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
- •Patient over 18 years old
- •Patients alive after more than three years from diagnosis with stage IV or Stage III NSCLC or SCLC, not treated with cytotoxic chemotherapy at the time of inclusion (the patient may be undergoing imunotherapy, targeted therapy or surveillance).
- •Patients covered by the French National Health Insurance program or with thirdparty-payer health insurance
排除标准
- •Difficulties for understanding French
- •Patients undergoing treatment with cytotoxic chemotherapy
- •Patients under legal guardianship, under curatorship or tutorship
- •Insufficient cognitive capacity to answer questions
- •Inability to obtain data collection (lost to follow-up, patient's refusal for data collection)
- •Patients refusing the collection of their data (an information sheet will be provided)
研究组 & 干预措施
Long-Terms Responders in metastatic Lung Cancer
Long-term responders defined as patients alive for three years after diagnosis of metastatic Lung cancer (NSCLC and SCLC) and not receiving cytotoxic chemotherapy at the time of inclusion.
干预措施: Hospital Anxiety and Depression scale (HAD) (Behavioral)
Long-Terms Responders in metastatic Lung Cancer
Long-term responders defined as patients alive for three years after diagnosis of metastatic Lung cancer (NSCLC and SCLC) and not receiving cytotoxic chemotherapy at the time of inclusion.
干预措施: Quality of Life Questionnaire - Lung Cancer 13 (QLQ-LC13) (Behavioral)
Long-Terms Responders in metastatic Lung Cancer
Long-term responders defined as patients alive for three years after diagnosis of metastatic Lung cancer (NSCLC and SCLC) and not receiving cytotoxic chemotherapy at the time of inclusion.
干预措施: Questionnaire Aix-Marseille-Université (AMU) (Behavioral)
结局指标
主要结局
Baseline Clinical Characteristics
时间窗: At Baseline visit, on a maximum period of 12 months.
Metastatic Lung Cancer Long-Terms Responders clinical characteristics: baseline patient demographics, clinical and pathological characteristics (e.g. age, medical history, comorbidities, past history of cancer, smoking status, NSCLC or SCLC characteristics)
Aix-Marseille-University (AMU) questionnaire
时间窗: At inclusion, 6 and 12 months after inclusion and every year up to 5 years
EORTC QLQ-LC13
时间窗: at inclusion, 6 and 12 months after inclusion and every year up to 5 years
Hospital Anxiety and Depression Scale (HAD)
时间窗: at inclusion, 6 and 12 months after inclusion and every year up to 5 years
Treatment characteristics
时间窗: From date of first lung cancer treatment administration up to 5 years
Treatment characteristics are defined by the type of treatment, the numbers of cycle and the duration of treatment.
Health status
时间窗: At Baseline visit and up to 5 years
Health status will be evaluated using Eastern Cooperative Oncology Group performance status (PS), and collecting data new diseases, cardiovascular, diabetes, second cancers
Socio-demographic characteristics
时间窗: At Baseline visit and up to 5 years
Socio-demographic characteristics will be evaluated based on the following data: professional, socio-family and socio-economic characteristics, education, family status, potential professional exposure(s)
次要结局
- Progression free survival (PFS)(From date of first lung cancer treatment administration up to 5 years)
- Overall Survival (OS)(From date of first lung cancer treatment initiation up to 5 years)