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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| none (observational study) | Other | only assessments via questionnaires, no interventions |
| Measure | Description | Time Frame |
|---|---|---|
| EORTC QLQ-FA12 | 12-item multidimensional fatigue questionnaire | Assessment time point: about 1-2 years post-diagnosis |
| Brief Fatigue Inventory (BFI) | Questionnaire on the impact of fatigue | Assessment time point: about 1-2 years post-diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| EORTC QLQ-C30 | Quality of Life questionnaire | Assessment time point: about 1-2 years post-diagnosis |
| PHQ-4 | Anxiety and Depression Screen |
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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, except non-malignant, unspecified, or in-situ neoplasm of skin (C44 or D0.4)
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Cancer patients who were diagnosed 1-2 years ago
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| German Cancer Research Center | Heidelberg | 69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32893501 | Result | Schmidt ME, Hermann S, Arndt V, Steindorf K. Prevalence and severity of long-term physical, emotional, and cognitive fatigue across 15 different cancer entities. Cancer Med. 2020 Nov;9(21):8053-8061. doi: 10.1002/cam4.3413. Epub 2020 Sep 7. | |
| 32860177 | Result | Schmidt ME, Bergbold S, Hermann S, Steindorf K. Knowledge, perceptions, and management of cancer-related fatigue: the patients' perspective. Support Care Cancer. 2021 Apr;29(4):2063-2071. doi: 10.1007/s00520-020-05686-5. Epub 2020 Aug 29. |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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| Assessment time point: about 1-2 years post-diagnosis |
| State of fatigue management | Questionnaire on Screening, primary evaluation, and received counseling, treatment and interventions for fatigue | Assessment time point: about 1-2 years post-diagnosis |
| Patient's believes and knowledge with regard to fatigue | 7 Likert-items regarding believes and knowledge about fatigue | Assessment time point: about 1-2 years post-diagnosis |
| 36314131 | Derived | Schmidt ME, Blickle P, Steindorf K. Cancer-related fatigue: Identification of hallmarks to enable refined treatment approaches. Psychooncology. 2022 Dec;31(12):2169-2176. doi: 10.1002/pon.6061. Epub 2022 Nov 9. |