Longitudinal Investigation of Cancer-related Fatigue (LIFT)
A Prospective, Observational Study to Investigate Longterm Courses, Patterns, Determinants and State of Treatment of Cancer-related Fatigue in Germany (LIFT)
研究概览
地位
条件
详细说明
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.
研究类型
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- ≥ 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.
Exclusion Criteria:
• Any additional malignant or unclear neoplasm or carcinoma in situ at or since time of diagnosis of the considered primary tumor
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
Patient cohort
Newly diagnosed breast, ovarian or colon cancer patients recruited 6 months post-diagnosis and followed up to 5 years post-diagnosis.
No intervention.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fatigue severity
大体时间：from diagnosis to 1 year post-diagnosis
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assessed by EORTC QLQ-FA12 (European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire)
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from diagnosis to 1 year post-diagnosis
|
|
Impact of fatigue
大体时间：from diagnosis to 1 year post-diagnosis
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assessed by the Brief Fatigue Inventory (BFI)
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from diagnosis to 1 year post-diagnosis
|
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State of fatigue management
大体时间：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
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from diagnosis to 1 year post-diagnosis
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of life functions and symptoms
大体时间：6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
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assessed by EORTC QLQ-C30
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6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
|
|
Sleep problems
大体时间：6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
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assessed by Pittsburgh Sleep Quality Index (PSQI)
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6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
|
|
Depression
大体时间：6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
|
assessed by Patient Health Questionnaire (PHQ-9)
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6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
|
|
Body mass index
大体时间：6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
|
calculated from weight and height
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6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
|
|
Total physical activity
大体时间：6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
|
assessed by a questionnaire regarding walking, cycling, and exercise behavior
|
6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
|
|
Diurnal cortisol rhythm
大体时间：1 year post-diagnosis
|
assessed in saliva
|
1 year post-diagnosis
|
|
Return to work
大体时间：6, 12 months and 2, 3, 4, and 5 years post-diagnosis
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assessed by a questions regarding occupational issues
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6, 12 months and 2, 3, 4, and 5 years post-diagnosis
|
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Hot flashes
大体时间：6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
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assessed only for women
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6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
|
|
Anxiety
大体时间：6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
|
assessed by the Generalized Anxiety Disorder Questionnaire (GAD-7)
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6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- LIFT
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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