Fatigue Prevalence, Severity, and State of Treatment in Germany (FiX)
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|ClinicalTrials.gov Identifier: NCT03318224|
Recruitment Status : Recruiting
First Posted : October 23, 2017
Last Update Posted : February 15, 2019
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.
|Condition or disease||Intervention/treatment|
|Cancer-related Fatigue||Other: none (observational study)|
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|Official Title:||Fatigue in Germany - Examination of Prevalence, Severity, and State of Screening and Treatment|
|Actual Study Start Date :||November 30, 2017|
|Estimated Primary Completion Date :||July 31, 2019|
|Estimated Study Completion Date :||December 2028|
- Other: none (observational study)
only assessments via questionnaires, no interventions
- 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
- EORTC QLQ-C30 [ Time Frame: Assessment time point: about 1-2 years post-diagnosis ]Quality of Life questionnaire
- PHQ-4 [ Time Frame: Assessment time point: about 1-2 years post-diagnosis ]Anxiety and Depression Screen
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03318224
|Contact: Martina E Schmidt, PhD||+496221 firstname.lastname@example.org|
|Contact: Karen Steindorf, Prof, PhDemail@example.com|
|German Cancer Research Center||Recruiting|
|Heidelberg, Germany, 69120|
|Contact: Martina E Schmidt, Dr. +49 6221 422220 firstname.lastname@example.org|
|Principal Investigator: Karen Steindorf, Prof. Dr.|