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Completed

NCT Number: NCT03318224

Fatigue Prevalence, Severity, and State of Treatment in Germany

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.

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Key information

Conditions

Cancer-related Fatigue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

German Cancer Research Center

Heidelberg, 69120, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

None (Observational study)

Other

only assessments via questionnaires, no interventions

Primary outcomes

  1. EORTC QLQ-FA12

    Time frame: Assessment time point: about 1-2 years post-diagnosis

    12-item multidimensional fatigue questionnaire

  2. Brief Fatigue Inventory (BFI)

    Time frame: Assessment time point: about 1-2 years post-diagnosis

    Questionnaire on the impact of fatigue

Secondary outcomes

  1. EORTC QLQ-C30

    Time frame: Assessment time point: about 1-2 years post-diagnosis

    Quality of Life questionnaire

  2. PHQ-4

    Time frame: Assessment time point: about 1-2 years post-diagnosis

    Anxiety and Depression Screen

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

German Cancer Research Center

Other

Registry information

Official study title

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

Acronym: FiX

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Oct 23, 2017
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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