Cancer-related Fatigue
Conditions
Brief summary
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.
Interventions
OTHERnone (observational study)
only assessments via questionnaires, no interventions
Sponsors
German Cancer Research Center
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EORTC QLQ-FA12 | Assessment time point: about 1-2 years post-diagnosis | 12-item multidimensional fatigue questionnaire |
| Brief Fatigue Inventory (BFI) | Assessment time point: about 1-2 years post-diagnosis | Questionnaire on the impact of fatigue |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EORTC QLQ-C30 | Assessment time point: about 1-2 years post-diagnosis | Quality of Life questionnaire |
| PHQ-4 | Assessment time point: about 1-2 years post-diagnosis | Anxiety and Depression Screen |
| State of fatigue management | Assessment time point: about 1-2 years post-diagnosis | Questionnaire on Screening, primary evaluation, and received counseling, treatment and interventions for fatigue |
| Patient's believes and knowledge with regard to fatigue | Assessment time point: about 1-2 years post-diagnosis | 7 Likert-items regarding believes and knowledge about fatigue |
Countries
Germany
Outcome results
None listed