Evaluation of Gender Differences on the Psychosocial and Economic Impact in Patients With Advanced Non-small Cell Lung Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 344
- 试验地点
- 18
- 主要终点
- Psychosocial impact (Test Family APGAR, Partner Test and adapted Duke-UNC-11 Scale)
研究概览
简要总结
The purpose of this study is to evaluate of gender differences on the psychosocial and economic impact in patients with advanced non-small cell lung cancer.
详细描述
Multi-centre, prospective follow-up post-authorisation study of two patient cohorts with metastatic NSCLC (men and women). It will be stratified based on biological sex, age and smoking to guarantee homogeneity between the cohorts. The clinical procedures for assessing the tumour and the treatment response will be performed according to the site's standard 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
- •Patients diagnosed with stage IV NSCLC who are going to commence first line treatment
- •Patients over the age of 18
- •Patients who have granted their informed consent, preferably in writing, but otherwise, verbal with witnesses who are independent of the research team
- •Life expectancy of over three months
- •Speak fluent Spanish, in order to be able to complete the study questionnaires
- •Patients able to read and write with no problems
排除标准
- •Previous systemic treatment for metastatic NSCLC. The administration of neoadjuvant or adjuvant radiotherapy and/or chemotherapy is permitted provided it was completed major or equal 6 months prior
- •Dementia or a significantly altered mental state that could affect comprehension or the ability to grant informed consent
结局指标
主要结局
Psychosocial impact (Test Family APGAR, Partner Test and adapted Duke-UNC-11 Scale)
时间窗: 2 years
The procedures for assessing psychosocial impact are: Test Family APGAR, Partner Test and adapted Duke-UNC-11 Scale. These tests will be performed by the investigator at visit baseline, visit 2 visit 3 and visit 4, according to the site's standard practice until patient death or for up to 24 months from the time of inclusion.
Economic impact (employment status, working hours, income range, public assistance, family support ...)
时间窗: 2 years
The procedures for assessing economic impact are some specific economic variables (employment status, working hours, income range, public assistance, family support ...)
次要结局
- Psychosocial and economic impact on the primary caregiver (Zarit Caregiver Burden Questionnaire and Test assessing the economic impact)(2 years)
- Influence of treatment (reatment received, treatment received, tumour ssessment, Medical history, including history of smoking, ECOG performance status, associated medical conditions and prior treatments administered (surgery, adjuvant treatment).(2 years)