Trial document



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  DRKS00005385

Trial Description

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Title

Influence of Medical Rehabilitation on Quality of Life in Patients with Chronic Myeloid Leukemia (CML)

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Trial Acronym

REHA-CML

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URL of the Trial

http://www.rehaklinik-thueringen.de

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Brief Summary in Lay Language

Major Goal: Investigation, if and how much quality of life can be improved by medical rehabilitation in patients with chronic myeloid leukemia (CML).
Background: Up to now, no data are available which show an improved quality of life induced by medical rehabilitation in patients with CML.
Methods: Evaluation of standardised and validated questionaries at the beginning, the end and one year after rehabilitation
Study participants: patients with or after CML who are in the Masserberger Klinik (Thueringen, Germany) for medical rehabiltation
Aims: Evaluation of alterations of the quality of life by medical rehabilitation
Hypothesis: a significant improvement of the quality of life can be achieved by an appropriated medical rehabilitation.

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Brief Summary in Scientific Language

Evaluation of the quality of life using standardised and validated questionaries (e. g. EORTC-QLQ C30 and EORTC-QLQ-CML24) at the beginning, the end and one year aftre rehabilitation; statisitcal evaluation of the questionaries.

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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

  •   DRKS00005385
  •   2014/01/07
  •   [---]*
  •   yes
  •   Approved
  •   44421/2013/150, Ethikkommission der Landesärztekammer Thüringen
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Secondary IDs

  •   U1111-1149-8643 
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Health Condition or Problem studied

  •   C92.1 -  Chronic myeloid leukaemia
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Interventions/Observational Groups

  •   Patients with or after CML are asked to answer the quality of life questionary at the beginning of the rehabilitation, at the end and one year thereafter
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Improvement of the quality of life is determined by evaluation of the EORTC questionaries (EORTC-QLQ 30 und EORTC QLQ-CML24). Timepoints: at the beginning of the rehabilitation, at the end and one year thereafter

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2014/01/20
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients with or after CML, i. e. under treatment or after treatment because of CML

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Exclusion Criteria

Patients withour CML; patients who do not participate in a medical rehabilitation or who do not want to participate in the study.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Masserberger Klinik Prof. Volhard - Prof. Georg Lenz
    • Mr.  PD Dr. med.  Andreas  Willer 
    • Hauptstrasse 18
    • 98666  Masserberg
    • Germany
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    • Masserberger Klinik Prof. Volhard - Prof. Georg Lenz
    • Mr.  PD Dr. med.  Andreas  Willer 
    • Hauptstrasse 18
    • 98666  Masserberg
    • Germany
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    • Masserberger Klinik Prof. Volhard - Prof. Georg Lenz
    • Mr.  PD Dr. med.  Andreas  Willer 
    • Hauptstrasse 18
    • 98666  Masserberg
    • Germany
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Sources of Monetary or Material Support

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    • Masserberger Klinik Prof. Volhard - Prof. Georg Lenz
    • Mr.  PD Dr. med.   Andreas   Willer 
    • Hauptstrasse 18
    • 98666   Masserberg
    • Germany
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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.