Fatigue Prevalence, Severity, and State of Treatment in Germany

Study Overview
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Brief Summary
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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.

Official Title
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Fatigue in Germany - Examination of Prevalence, Severity, and State of Screening and Treatment

Conditions
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Cancer-related Fatigue

Intervention / Treatment
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* Other: none (observational study)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: none (observational study)|only assessments via questionnaires, no interventions|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |