Trial document





This trial has been registered retrospectively.
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  DRKS00016034

Trial Description

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Title

Cancer related Fatigue Intervention

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Trial Acronym

CarFI

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URL of the Trial

https://www.ukw.de/palliativmedizin/forschung/

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Brief Summary in Lay Language

Cancer patients suffer from severe exhaustion and tiredness that is disproportionate to previous efforts and that cannot be completely reduced by sleep. The effectiveness of knowledge transfer and action recommendations for dealing with this fatigue and mindfulness-based movement and relaxation therapy are to be tested.

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Brief Summary in Scientific Language

In a randomized controlled trial, the effect of psychoeducation and mindfulness-based exercise therapy (yoga) on curative and palliative cancer patients with fatigue symptoms will be investigated.

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Organizational Data

  •   DRKS00016034
  •   2018/12/04
  •   [---]*
  •   yes
  •   Approved
  •   59/18, Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   oncological diseases
  •   C00-C97 -  Malignant neoplasms
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Interventions/Observational Groups

  •   8-week yoga intervention, once a week for 1 h + single psychoeducation for 1,5h
  •   single psychoeducation for 1,5h
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Control group receives no treatment
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The primary outcome of this study is fatigue. Fatigue is measured at the beginning, after the intervention and at the 6-month follow-up for the intervention group. The waiting control group completes the questionnaire 10 weeks after the basic assessment or before the yoga intervention. Fatigue is measured with EORTC QLQ-FA13 13 Items (European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire - Fatigue; Weis et al. 2017). Fatigue is measured in 3 dimensions with 13 elements: Physically, emotionally and cognitively. There are four answer categories "not at all", "a little", "quite a lot" and "very much", coded with values from 1 to 4: According to the scales of the EORTC QLQ-C30, the FA13 results are converted into a range from 0-100. Higher values indicate a higher level of fatigue.

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Secondary Outcome

The following secondary endpoints are measured at the beginning, after the intervention and 6 months after the intervention.
- Depression (PHQ9)
- Quality of life (EORTC QLQ-C15-PAL)
- Distress (distress thermometer)
- Symptom burden (ESAS)
- Sense of coherence (SOC L9)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/10/12
  •   124
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- oncological disease
- noticeable fatigue screening
- Ability to consent

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Exclusion Criteria

- severe physical and/or psychological impairment
- insufficient German language skills
- Approach route >50km

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Addresses

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    • Interdisziplinäres Zentrum Palliativmedizin Klinik und Poliklinik für Strahlentherapie Universitätsklinikum Würzburg
    • Ms.  Prof. Dr. med.  Birgitt  van Oorschot 
    • Joseph-Schneider-Str. 2
    • 97080  Würzburg
    • Germany
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    • Universitätsklinikum Würzburg
    • Ms.  Teresa  Zetzl 
    • Josef-Schneider-Str.2
    • 97080  Würzburg
    • Germany
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    •   0931 201 28855
    •   [---]*
    •   Zetzl_T at ukw.de
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    • Universitätsklinikum Würzburg
    • Ms.  Teresa  Zetzl 
    • Josef-Schneider-Str.2
    • 97080  Würzburg
    • Germany
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    •   0931 201 28855
    •   [---]*
    •   Zetzl_T at ukw.de
    •   [---]*
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Sources of Monetary or Material Support

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    • Deutsche Krebshilfe gGmbH
    • Mr.  Dr. h.c.  Fritz  Pleitgen 
    • Buschstraße 32
    • 53113  Bonn
    • Germany
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Status

  •   Recruiting ongoing
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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.