Clinical trial · Observational
Fatigue Prevalence, Severity, and State of Treatment in Germany
Fatigue in Germany - Examination of Prevalence, Severity, and State of Screening and Treatment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-related Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| none (observational study) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- EORTC QLQ-FA12
- timeFrame
- Assessment time point: about 1-2 years post-diagnosis
- description
- 12-item multidimensional fatigue questionnaire
- measure
- Brief Fatigue Inventory (BFI)
- timeFrame
- Assessment time point: about 1-2 years post-diagnosis
- description
- Questionnaire on the impact of fatigue
Secondary outcomes (4)
- measure
- EORTC QLQ-C30
- timeFrame
- Assessment time point: about 1-2 years post-diagnosis
- description
- Quality of Life questionnaire
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 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. 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)
References
Publications (3)
- RESULTSchmidt 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. PMID 32893501
- RESULTSchmidt 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. PMID 32860177
- DERIVEDSchmidt 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. PMID 36314131