A Prospective, Observational Study to Investigate Longterm Courses, Patterns, Determinants and State of Treatment of Cancer-related Fatigue in Germany (LIFT)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Impact of fatigue
研究概览
简要总结
In the LIFT study 2000 cancer patients will be recruited at 6 months after diagnosis and extensively surveyed over five years on factors that are associated with fatigue.
详细描述
The LIFT study aims to comprehensively investigate characteristics, determinants, and long-term course of fatigue. In addition, information shall be gained on the current state of fatigue treatment and care in Germany and on the needs of affected patients.
Data will be collected by mailed or online questionnaires at 6, 9, and 12 months as well as 2, 3, 4 and 5 years post-diagnosis from 2000 cancer patients. Besides questionnaires on socio-demographic, clinical and patient reported outcomes, saliva samples will be collected in order to gain new insights into biological mechanisms. Moreover, detailed data on screening, diagnosis and counseling as well as therapies offered and administered to reduce fatigue will be surveyed, as well as the patients' state of knowledge, perception and prevailing needs regarding fatigue. Tumor and cancer therapy data will be extracted from the Epidemiological Cancer Registry.
The results of the LIFT study aim to contribute to an improved, evidence-based and individualized treatment to avoid and ease cancer-related fatigue and will further promote patient-oriented offers and treatments.
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
- •≥ 18 years of age
- •Diagnosed with a primary tumor of breast, ovarian, or colon cancer
- •Time since first diagnosis is 4 - 6 months
- •Having received or currently receiving at least one of the following treatments: surgery, chemotherapy, radiotherapy, hormone therapy, or immune therapy.
- •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
结局指标
主要结局
Impact of fatigue
时间窗: from diagnosis to 1 year post-diagnosis
assessed by the Brief Fatigue Inventory (BFI)
Fatigue severity
时间窗: from diagnosis to 1 year post-diagnosis
assessed by EORTC QLQ-FA12 (European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire)
State of fatigue management
时间窗: from diagnosis to 1 year post-diagnosis
Questionnaire assessing the adherence to the National Comprehensive Cancer Network (NCCN) guidelines regarding management of cancer-related fatigue
次要结局
- Quality of life functions and symptoms(6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis)
- Body mass index(6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis)
- Sleep problems(6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis)
- Total physical activity(6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis)
- Depression(6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis)
- Diurnal cortisol rhythm(1 year post-diagnosis)
- Return to work(6, 12 months and 2, 3, 4, and 5 years post-diagnosis)
- Hot flashes(6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis)
- Anxiety(6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis)