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Trial record 1 of 1 for:    NCT03318224 | Recruiting, Not yet recruiting Studies
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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
Sponsor:
Information provided by (Responsible Party):
German Cancer Research Center

Brief 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. 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)

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue


Intervention Details:
  • Other: none (observational study)
    only assessments via questionnaires, no interventions


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cancer patients who were diagnosed 1-2 years ago
Criteria

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)


Information from the National Library of Medicine

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


Contacts
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Contact: Martina E Schmidt, PhD +496221 422220 m.schmidt@dkfz.de
Contact: Karen Steindorf, Prof, PhD k.steindorf@dkfz.de

Locations
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Germany
German Cancer Research Center Recruiting
Heidelberg, Germany, 69120
Contact: Martina E Schmidt, Dr.    +49 6221 422220    m.schmidt@dkfz.de   
Principal Investigator: Karen Steindorf, Prof. Dr.         
Sponsors and Collaborators
German Cancer Research Center

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Responsible Party: German Cancer Research Center
ClinicalTrials.gov Identifier: NCT03318224     History of Changes
Other Study ID Numbers: FiX
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatigue
Signs and Symptoms