Trial document
DRKS00005385
Trial Description
Title
Influence of Medical Rehabilitation on Quality of Life in Patients with Chronic Myeloid Leukemia (CML)
Trial Acronym
REHA-CML
URL of the Trial
http://www.rehaklinik-thueringen.de
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.
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.
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
Secondary IDs
- U1111-1149-8643
Health Condition or Problem studied
- C92.1 - Chronic myeloid leukaemia
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
Characteristics
- Non-interventional
- Observational study
- Single arm study
- Open (masking not used)
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- Uncontrolled/Single arm
- Supportive care
- Single (group)
- N/A
- N/A
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
Secondary Outcome
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Countries of Recruitment
- Germany
Locations of Recruitment
- Medical Center
Recruitment
- Planned
- 2014/01/20
- 50
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- 99 Years
Additional Inclusion Criteria
Patients with or after CML, i. e. under treatment or after treatment because of CML
Exclusion Criteria
Patients withour CML; patients who do not participate in a medical rehabilitation or who do not want to participate in the study.
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-sponsorstart of 1:1-Block address contact primary-sponsor- 03687081590
- 03687081199
- a.willer at rehaklinik-thuerigen.de
- [---]*
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-contactstart of 1:1-Block address contact scientific-contact- 03687081590
- 03687081199
- a.willer at rehaklinik-thueringen.de
- [---]*
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-contactstart of 1:1-Block address contact public-contact- 03687081590
- 03687081199
- a.willer at rehaklinik-thueringen.de
- [---]*
end of 1:1-Block address contact public-contact
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 materialSupportstart of 1:1-Block address contact materialSupport- 03687081590
- 03687081199
- a.willer at rehaklinik-thueringen.de
- [---]*
end of 1:1-Block address contact materialSupport
Status
- Recruiting planned
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Trial Publications, Results and other Documents
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