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

June 5, 2023 updated by: German Cancer Research Center

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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2508

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EORTC QLQ-FA12
Time Frame: Assessment time point: about 1-2 years post-diagnosis
12-item multidimensional fatigue questionnaire
Assessment time point: about 1-2 years post-diagnosis
Brief Fatigue Inventory (BFI)
Time Frame: Assessment time point: about 1-2 years post-diagnosis
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
Time Frame: Assessment time point: about 1-2 years post-diagnosis
Quality of Life questionnaire
Assessment time point: about 1-2 years post-diagnosis
PHQ-4
Time Frame: Assessment time point: about 1-2 years post-diagnosis
Anxiety and Depression Screen
Assessment time point: about 1-2 years post-diagnosis
State of fatigue management
Time Frame: Assessment time point: about 1-2 years post-diagnosis
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
Time Frame: Assessment time point: about 1-2 years post-diagnosis
7 Likert-items regarding believes and knowledge about fatigue
Assessment time point: about 1-2 years post-diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Cancer Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2017

Primary Completion (Actual)

May 10, 2019

Study Completion (Estimated)

December 1, 2028

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)

June 6, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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