Cancer-related FatigueFiXNCT03318224
Fatigue Prevalence, Severity, and State of Treatment in Germany
An observational study of Cancer-related Fatigue, run by German Cancer Research Center at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer-related Fatigue
- What is being tested?
- none (observational study)
- How many people
- 2,508 participants
- Where
- 1 siteGermany
- Study dates
- 30 Nov 2017to 30 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patients who were diagnosed 1-2 years ago
Who may be able to join
- ≥ 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Cancer-related Fatigue
- Being tested
- none (observational study)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none (observational study)Other
only assessments via questionnaires, no interventions
What is being measured
The primary outcome is the main question the study is designed to answer.
EORTC QLQ-FA12
12-item multidimensional fatigue questionnaire
Measured: Assessment time point: about 1-2 years post-diagnosis
Brief Fatigue Inventory (BFI)
Questionnaire on the impact of fatigue
Measured: Assessment time point: about 1-2 years post-diagnosis
Secondary outcomes (4)
EORTC QLQ-C30
Quality of Life questionnaire
Measured: Assessment time point: about 1-2 years post-diagnosis
PHQ-4
Anxiety and Depression Screen
Measured: 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
Measured: 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
Measured: Assessment time point: about 1-2 years post-diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start30 Nov 2017
- Primary completion10 May 2019
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cancer-related FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,508 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Cancer Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318224
- Sponsor's protocol ID
- FiX
- Acronym
- FiX
- Status last verified
- Dec 2024
- First submitted
- 18 Oct 2017
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32893501Schmidt 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.
PubMed 32860177Schmidt 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.
PubMed 36314131
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fatigue in Germany - Examination of Prevalence, Severity, and State of Screening and Treatment
- ClinicalTrials.gov ID
- NCT03318224
- Acronym / sponsor ID
- FiX / FiX
- Conditions
- Cancer-related Fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,508 participants (actual)
- Lead sponsor
- German Cancer Research CenterUniversity, hospital or other
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients who were diagnosed 1-2 years ago
Key inclusion criteria (4 listed)
- ≥ 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.
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| none (observational study)only assessments via questionnaires, no interventions | Other | – |
Primary outcome
EORTC QLQ-FA12
Time frame: Assessment time point: about 1-2 years post-diagnosis
12-item multidimensional fatigue questionnaire
Brief Fatigue Inventory (BFI)
Time frame: Assessment time point: about 1-2 years post-diagnosis
Questionnaire on the impact of fatigue
4 secondary outcomes
EORTC QLQ-C30
Time frame: Assessment time point: about 1-2 years post-diagnosis
PHQ-4
Time frame: Assessment time point: about 1-2 years post-diagnosis
State of fatigue management
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Results publication: PubMed 32893501Schmidt 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.
- Results publication: PubMed 32860177Schmidt 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.
- Derived from this study: PubMed 36314131Schmidt 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer-related Fatigue, run by German Cancer Research Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EORTC QLQ-FA12 (time frame: Assessment time point: about 1-2 years post-diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03318224, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.