Fatigue Prevalence, Severity, and State of Treatment in Germany

Cancer-related Fatigue Clinical Trial

— FiX  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03318224
• Other study ID #: FiX
• Status: Active, not recruiting
• Start date: November 30, 2017
• Est. completion date: December 2028

Study information

• Verified date: June 2023
• Source: German Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2508
• Est. completion date: December 2028
• Est. primary completion date: May 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer-related Fatigue
• Fatigue

Intervention

Other:
• none (observational study)
only assessments via questionnaires, no interventions

Locations

Country	Name	City	State
Germany	German Cancer Research Center	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
German Cancer Research Center

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EORTC QLQ-FA12	12-item multidimensional fatigue questionnaire	Assessment time point: about 1-2 years post-diagnosis
Primary	Brief Fatigue Inventory (BFI)	Questionnaire on the impact of fatigue	Assessment time point: about 1-2 years post-diagnosis
Secondary	EORTC QLQ-C30	Quality of Life questionnaire	Assessment time point: about 1-2 years post-diagnosis
Secondary	PHQ-4	Anxiety and Depression Screen	Assessment time point: about 1-2 years post-diagnosis
Secondary	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
Secondary	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