Trial document



drksid header

  DRKS00005385

Trial Description

start of 1:1-Block title

Title

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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

REHA-CML

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.rehaklinik-thueringen.de

end of 1:1-Block url
start of 1:1-Block public summary

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.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

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.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005385
  •   2014/01/07
  •   [---]*
  •   yes
  •   Approved
  •   44421/2013/150, Ethikkommission der Landesärztekammer Thüringen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1149-8643 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C92.1 -  Chronic myeloid leukaemia
end of 1:N-Block indications
start of 1:N-Block interventions

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
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

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

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

/

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2014/01/20
  •   50
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

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
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Masserberger Klinik Prof. Volhard - Prof. Georg Lenz
    • Mr.  PD Dr. med.  Andreas  Willer 
    • Hauptstrasse 18
    • 98666  Masserberg
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Masserberger Klinik Prof. Volhard - Prof. Georg Lenz
    • Mr.  PD Dr. med.  Andreas  Willer 
    • Hauptstrasse 18
    • 98666  Masserberg
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Masserberger Klinik Prof. Volhard - Prof. Georg Lenz
    • Mr.  PD Dr. med.   Andreas   Willer 
    • Hauptstrasse 18
    • 98666   Masserberg
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.