Fatigue Prevalence, Severity, and State of Treatment in Germany

Completed

• Conditions: Cancer-related Fatigue

• Registration Number: NCT03318224
• Lead Sponsor: German Cancer Research Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-18
• Study First Submitted QC: 2017-10-20
• Study First Posted: 2017-10-23
• Study Start: 2017-11-30
• Primary Completion: 2019-05-10
• Study Completion: 2021-04-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2508

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.

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

German Cancer Research Center; 🇩🇪 Heidelberg, Germany