Trial document




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  DRKS00003091

Trial Description

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Title

International Cross-Cultural Field Validation of an EORTC Questionnaire Module for the Assessment of Cancer Related Fatigue (EORTC QLQ FA13) - Phase IV

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Trial Acronym

EORTC QLQ-FA13

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URL of the Trial

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Brief Summary in Lay Language

Development of a questionnaire measuring cancer related fatigue : Anti-cancer treatment with chemotherapy, radiotherapy or other treatment modalities may cause a wide range of side effects or long term sequelae. Fatigue is one of the most frequently occurring problems during and after tumour therapy. We know that fatigue may influence the patients’ daily life, social functioning and quality of life, both in a short-term as well as in a long-term perspective. Thus it is of great importance that these problems are systematically assessed in all types of settings before, during and after treatment for cancer. A systematic assessment will show the need for interventions at an early stage, will alleviate fatigue and also prevent the development of serious problems. For this purpose currently a widely used questionnaire is the EORTC QLQ-C30. Complementary to this questionnaire we developed in the phase III of our study a new module (EORTC QLQ-FA13) measuring fatigue more in detail. The purpose of the phase IV of our study is to improve this existing fatigue module in terms of psychometrical aspects.

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Brief Summary in Scientific Language

International Cross-Cultural Field Validation of an EORTC Questionnaire Module for the Assessment of Cancer Related Fatigue: EORTC QLQ-FA13. - In collaboration with 31 multi-professional specialists from eight European countries (Germany, Austria, UK, France, Italy, Spain, Norway and Netherlands), the EORTC QLQ-FA13 Fatigue Module was developed according to guidelines published by the Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Department. This Fatigue Module is planned to be used with the EORTC Quality of Life core-questionnaire (EORTC QLQ-C30).
The objective of this study is to test the reliability, clinical and psychometric validity of the EORTC QLQ-FA13 (Quality of Life Questionnaire Fatigue Module) in an international sample of tumour patients.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00003091
  •   2011/06/28
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  •   yes
  •   Approved
  •   165/11, Ethik-Kommission der Albert-Ludwig-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   Cancer related fatigue
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Interventions/Observational Groups

  •   Cancer patients with first-line treatment with curative intension. Schedule of the assessments according to the study protocol: before (T1), during (T2) and after (T3) the treatment. Used instruments: T1: Global Scale of Cancer Related Fatigue, EORTC QLQ-C30, EORTC QLQ-FA13, Clinical Data and Socio-Demographic Form; T2: EORTC QLQ-C30, EORTC QLQ-FA13; T3: EORTC QLQ-C30, EORTC QLQ-FA13.
  •   Cancer patients with second-line treatment with palliative intension. Schedule of the assessments according to the study protocol: before (T1), during (T2) and after (T3) the treatment. Used instruments: T1: Global Scale of Cancer Related Fatigue, EORTC QLQ-C30, EORTC QLQ-FA13, Clinical Data and Socio-Demographic Form; T2: EORTC QLQ-C30, EORTC QLQ-FA13; T3: EORTC QLQ-C30, EORTC QLQ-FA13.
  •   Cancer patients off treatment for at least 12 but no more than 18 months and no evidence of cancer disease or recurrence. Schedule of the assessments: two times (the second assessment is one week after the first). Used instruments: T1: Global Scale of Cancer Related Fatigue, EORTC QLQ-C30, EORTC QLQ-FA13, Clinical Data and Socio-Demographic Form; T2: EORTC QLQ-C30, EORTC QLQ-FA13.
  •   Cancer patients off treatment for more than 36 but no more than 72 months (survivors) and no evidence of cancer disease or recurrence. Schedule of the assessments: two times (the second assessment is one week after the first). Used instruments: T1: Global Scale of Cancer Related Fatigue, EORTC QLQ-C30, EORTC QLQ-FA13, Clinical Data and Socio-Demographic Form; T2: EORTC QLQ-C30, EORTC QLQ-FA13.
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Other
  •   N/A
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Primary Outcome

International Cross-Cultural Field Validation of an EORTC Questionnaire Module for the Assessment of Cancer Related Fatigue (EORTC QLQ FA13)

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Secondary Outcome

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Countries of Recruitment

  •   Germany
  •   Sweden
  •   Italy
  •   Spain
  •   Austria
  •   France
  •   United Kingdom
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Locations of Recruitment

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Recruitment

  •   Planned
  •   2011/07/04
  •   512
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   100   Years
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Additional Inclusion Criteria

Age 18 years or older (no upper limit);
Histologically confirmed cancer

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Exclusion Criteria

Patients undergoing allogeneic HSCT; Participation in other quality of life studies;
Disability to understand the language of the questionnaire. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.

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Addresses

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    • Klinik für Tumorbiologie
    • Mr.  Prof. Dr.  Joachim  Weis 
    • Breisacher Str. 117
    • 79106  Freiburg im Breisgau
    • Germany
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    • Klinik für Tumorbiologie
    • Mr.  Prof. Dr.  Joachim  Weis 
    • Breisacher Str. 117
    • 79106  Freiburg im Breisgau
    • Germany
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    • Klinik für Tumorbiologie
    • Mr.  Prof. Dr.  Joachim  Weis 
    • Breisacher Str. 117
    • 79106  Freiburg im Breisgau
    • Germany
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Sources of Monetary or Material Support

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    • EORTC European Organisation for Research and Treatment of Cancer
    • Avenue Mounierlaan, 83/11
    • 1200  Brussel
    • Belgium
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.