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| Name | Class |
|---|---|
| University Hospital Heidelberg | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Measure | Description | Time Frame |
|---|---|---|
| Fatigue severity | assessed by EORTC QLQ-FA12 (European Organisation for Research and Treatment of Cancer Quality of Life Fatigue Questionnaire) | from diagnosis to 1 year post-diagnosis |
| Impact of fatigue | assessed by the Brief Fatigue Inventory (BFI) | from diagnosis to 1 year post-diagnosis |
| State of fatigue management | Questionnaire assessing the adherence to the National Comprehensive Cancer Network (NCCN) guidelines regarding management of cancer-related fatigue | from diagnosis to 1 year post-diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life functions and symptoms | assessed by EORTC QLQ-C30 | 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis |
| Sleep problems | assessed by Pittsburgh Sleep Quality Index (PSQI) |
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Inclusion Criteria:
Exclusion Criteria:
• Any additional malignant or unclear neoplasm or carcinoma in situ at or since time of diagnosis of the considered primary tumor
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Patients newly diagnosed with breast, ovarian or colon cancer
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Diurnal saliva samples (5 samples distributed over a day)
| 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis |
| Depression | assessed by Patient Health Questionnaire (PHQ-9) | 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis |
| Body mass index | calculated from weight and height | 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis |
| Total physical activity | 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 | assessed in saliva | 1 year post-diagnosis |
| Return to work | assessed by a questions regarding occupational issues | 6, 12 months and 2, 3, 4, and 5 years post-diagnosis |
| Hot flashes | assessed only for women | 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis |
| Anxiety | assessed by the Generalized Anxiety Disorder Questionnaire (GAD-7) | 6, 9, 12 months and 2, 3, 4, and 5 years post-diagnosis |