Fatigue in Germany - Examination of Prevalence, Severity, and State of Screening and Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,508
- 试验地点
- 1
- 主要终点
- EORTC QLQ-FA12
研究概览
简要总结
Fatigue is a major concern during and after cancer therapy with severe impact on quality of life. Yet, sound comparable data on fatigue prevalence, severity, and impact on daily life across different tumor entities is lacking. Furthermore, little is known about the current state of screening, counselling and treatment of fatigue.
Thus, the FiX-Study aims to assess such data to identify patient groups with especial need for an improved fatigue management and treatment.
A minimum of n=3000 patients about equally distributed about the 16 most common tumor entities shall be recruited between year 1 and 2 after primary cancer diagnosis via the cancer registry Baden-Württemberg. Data on fatigue (EORTC QLQ-FA12, BFI), quality of life (EORTC QLQ-C30), depression and anxiety (PAQ-4), and information about screening and treatment of fatigue will be assessed via self-reported questionnaires. Clinical data regarding tumor and treatment characteristics will be derived from the cancer registry.
This trial is imbedded in a larger research agenda on fatigue and will provide the basis for the development of an individually-tailored fatigue program.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •≥ 18 years of Age
- •Diagnosed with a primary tumor of one of the following malignant neoplasms (including in-situ carcinoma): stomach (C16, D00.2), colon (C18, D01.0), rectum (C19-20, D01.1-1.2), liver (C22, D01.5), pancreas (C25, D01.7), lung (C33-34, D02.1-2.2), malignant melanoma (C43, D03), breast (C50, D05, female only), cervix or ovaries (C53, D06), endometrium (C54.1, D07.0), ovaries (C56), prostate (C61), kidney (C64), bladder (C67, D09.0), non-Hodgkin lymphoma (C82-88), leukemia (C91-C95)
- •Time since first diagnosis is at least 1 year, maximal 2 years
- •Able to understand and follow the study protocol.
排除标准
- •Any additional malignant or unclear neoplasm or carcinoma in situ at or since time of diagnosis of the considered primary tumor, except non-malignant, unspecified, or in-situ neoplasm of skin (C44 or D0.4)
结局指标
主要结局
EORTC QLQ-FA12
时间窗: Assessment time point: about 1-2 years post-diagnosis
12-item multidimensional fatigue questionnaire
Brief Fatigue Inventory (BFI)
时间窗: Assessment time point: about 1-2 years post-diagnosis
Questionnaire on the impact of fatigue
次要结局
- Patient's believes and knowledge with regard to fatigue(Assessment time point: about 1-2 years post-diagnosis)
- EORTC QLQ-C30(Assessment time point: about 1-2 years post-diagnosis)
- PHQ-4(Assessment time point: about 1-2 years post-diagnosis)
- State of fatigue management(Assessment time point: about 1-2 years post-diagnosis)