Assessment of Disease Burden and Palliative Care Needs of Patients During the Course of Incurable Cancer Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 21
- 主要终点
- Change from Baseline Patient´s answers regarding symptom burden at 12 months
研究概览
简要总结
The aim of this non-investigational study is to determine the symptoms and disease burden at the time point of diagnosis and in the further course of an incurable cancer disease. The needs and preferences of patients suffering from cancer (ovarian carcinoma, breast cancer, malignant melanoma, lung cancer, stomach cancer, oesophageal cancer, pancreatic cancer, cancer of the hepatobiliary system, colorectal cancer, head and neck cancer) are examined by various validated questionnaires. The data obtained by these questionnaires are collected together with information obtained by the treating physicians at four time points during the study: t0 - patient´s enrollment, at the moment of diagnosis and before the start of tumor therapy, respectively; T1 - 3 months after patient´s enrollment; T2 - 6 months after patient´s enrollment; T3 - 12 months after patient´s enrollment. This highly innovative project offers the chance to identify medical services deficits and risk circumstances for the burden of treatments in an oncology-palliative setting and to optimize the quality of patient care.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Incurable cancer disease: ovarian carcinoma, breast cancer, malignant melanoma, lung cancer, stomach cancer, oesophageal cancer, pancreatic cancer, cancer of the hepatobiliary system, colorectal cancer, head and neck cancer
- •signed and dated Inform Consent Form
- •Age ≥ 18 years
排除标准
- •Patient is not able to understand and to answer questions
- •Patient is in a critical health situation and is directly threatened due to cancer disease or the resulting complications
结局指标
主要结局
Change from Baseline Patient´s answers regarding symptom burden at 12 months
时间窗: 12 months after enrollment
次要结局
- Change from Baseline Patient´s answers regarding symptom burden at 3 months(3 months after enrollment)
- Change from Baseline physician´s report at 3 months(3 months after enrollment)
- Change from Baseline physician´s report at 6 months(6 months after enrollment)
- Change from Baseline physician´s report at 12 months(12 months after enrollment)
- Change from Baseline Patient´s answers regarding symptom burden at 6 months(6 months after enrollment)
研究者
Florian Lordick, MD
Prof. Dr. med. (MD, PhD)
University of Leipzig