Tablet-based Prospective Patient Reported Outcomes (PRO) Registry in Patients With Advanced NSCLC or Advanced Pancreatic Cancer With Focus on Cancer Cachexia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- iOMEDICO AG
- 入组人数
- 253
- 试验地点
- 1
- 主要终点
- Rate of patients with loss of > 5 % body weight
研究概览
简要总结
Evaluation of patient reported outcomes (PRO) with tumor cachexia in a real life setting.
详细描述
The PRO Xie project will recruit a representative cohort of patients with advanced lung or advanced pancreatic cancer with a high risk for the development of cancer cachexia.
Patient Reported Outcomes (PRO) are assessed in a real life setting by a questionnaire consisting of 20 questions: QoL is measured by SF12, fatigue by FACIT-F and cachexia by FAACT questionnaires, respectively.
These data will determine the potential need for anti-cachexia treatment in those patients, as well as the number of underweight patients, the evaluation of general QoL, fatigue and cachexia and the evaluation of malnutrition.
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
- •Documented diagnosis of NSCLC UICC stage IIIB/IV or pancreatic cancer UICC stage III/IV
- •Start of the first line palliative systemic treatment
- •Ability to read and understand German
- •Written informed consent
排除标准
- 未提供
结局指标
主要结局
Rate of patients with loss of > 5 % body weight
时间窗: 18 months
次要结局
- Number of underweight patients(12 months)
- General health-related quality of life assessment(12 months)
- Fatigue assessment(12 months)
- Cachexia assessment(12 months)