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Fatigue Prevalence, Severity, and State of Treatment in Germany

NCT ID: NCT03318224

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2508 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-30

Study Completion Date

2021-04-30

Brief Summary

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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

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Conditions

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Cancer-related Fatigue

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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none (observational study)

only assessments via questionnaires, no interventions

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Cancer Research Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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German Cancer Research Center

Heidelberg, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 32893501 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32860177 (View on PubMed)

Schmidt ME, Blickle P, Steindorf K. Cancer-related fatigue: Identification of hallmarks to enable refined treatment approaches. Psychooncology. 2022 Dec;31(12):2169-2176. doi: 10.1002/pon.6061. Epub 2022 Nov 9.

Reference Type DERIVED
PMID: 36314131 (View on PubMed)

Other Identifiers

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FiX

Identifier Type: -

Identifier Source: org_study_id