Functional and Clinical Long-Term Outcome of Ewing Sarcoma Treatment
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|ClinicalTrials.gov Identifier: NCT00824083|
Recruitment Status : Completed
First Posted : January 16, 2009
Last Update Posted : April 28, 2016
|Condition or disease|
Trial objective: As survival rates of bone sarcoma patients have been raised owing to improved treatment strategies the focus of investigations is now on the medical, social, and economic sequelae of intensive multimodal treatment. This study aims to assess the functional outcome, quality of life and late sequelae in a representative sample of long-term survivors of Ewing sarcoma. The data recorded combined with standardized treatment data covering a 30-year period will produce a data pool that is unique for its magnitude and will be used for the development of guidelines for further improvements of future bone sarcoma treatment.
Working plan: The working plan provides for the assessment of functional outcome and quality of life by means of validated tools (TESS, SF36, PEDQOL) and objectively measuring daily activity patterns by using the Step Activity Monitor (SAM) in 600 long-term Ewing sarcoma survivors and a control group of 300 matched healthy subjects. Information on sarcoma treatment and follow-up is obtained by re-structuring and complementing the database of the relevant patient cohort (n=3000) from four consecutive nationwide and international clinical trials between 1980 and 2008. Procedures of local treatment will be evaluated regarding functional outcome, quality of life, and survival probability and prognostic factors predicting long-term outcome will be identified.
Exploitation of results: The results will be presented at scientific meetings and will be published in international journals. Guidelines will be developed regarding improvements in the treatment, rehabilitation, and social integration of bone sarcoma patients to be utilized in guiding patients and in the decision process of medical professionals regarding their treatment. In the long run, the evidence based guidelines on treatment and follow-up are to be transferred into the health system.
|Study Type :||Observational|
|Actual Enrollment :||950 participants|
|Official Title:||Functional and Clinical Long-Term Outcome of Ewing Sarcoma Treatment|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
- physical activity (SAM: step-activity-monitor) [ Time Frame: 3-30years after primary diagnosis of Ewing sarcoma ]
- health-related quality of life (SF36, PEDQOL) [ Time Frame: 3-30years after primary diagnosis of Ewing sarcoma ]
- functional status (TESS) [ Time Frame: 3-30years after primary diagnosis of Ewing sarcoma ]
- psychological status (HADS, BIS-BAS) [ Time Frame: 3-30years after primary diagnosis of Ewing sarcoma ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00824083
|Department of Pediatric Hematology and Oncology, University Children's Hospital|
|Muenster, North Rhine Westphalia, Germany, 48129|
|Motion Analysis Lab, Orthopedic Department, University Hospital|
|Münster, North Rhine Westphalia, Germany, 48129|
|Principal Investigator:||Andreas Ranft, Dr.||University Hospital Muenster|
|Study Chair:||Heribert Jürgens, Prof.||University Hospital Muenster|