Fatigue Prevalence, Severity, and State of Treatment in Germany (FiX)

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer-related Fatigue
• Intervention / Treatment: Other: none (observational study)

• Study Type: Observational
• Enrollment (Actual): 2508

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • German Cancer Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Cancer patients who were diagnosed 1-2 years ago

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: German Cancer Research Center

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2017
• Primary Completion (Actual): May 10, 2019
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: October 18, 2017
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Actual): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: FiX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No