Clinical trial NCT03318224: Fatigue Prevalence, Severity, and State of Treatment in Germany
Official title: Fatigue in Germany - Examination of Prevalence, Severity, and State of Screening and Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer-related Fatigue
Lead sponsor: German Cancer Research Center
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 2508
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Cancer patients who were diagnosed 1-2 years ago

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.


Eligibility criteria: 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)

Primary outcomes:
measure: EORTC QLQ-FA12
timeFrame: Assessment time point: about 1-2 years post-diagnosis
measure: Brief Fatigue Inventory (BFI)
timeFrame: Assessment time point: about 1-2 years post-diagnosis
Secondary outcomes:
measure: EORTC QLQ-C30
timeFrame: Assessment time point: about 1-2 years post-diagnosis
measure: PHQ-4
timeFrame: Assessment time point: about 1-2 years post-diagnosis
measure: State of fatigue management
timeFrame: Assessment time point: about 1-2 years post-diagnosis
measure: Patient's believes and knowledge with regard to fatigue
timeFrame: Assessment time point: about 1-2 years post-diagnosis
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: German Cancer Research Center
Study officials:
References:
citation: 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.
citation: 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.