Functional and Clinical Long-Term Outcome of Ewing Sarcoma Treatment

Study Overview
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Brief Summary
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The purpose of the study is to assess the functional outcome, quality of life and late sequelae in a representative sample of 600 long-term survivors of Ewing sarcoma and to build a unique clinical and functional data pool of the underlying cohort of 3000 Ewing sarcoma patients with a follow-up of 3 decades.

Detailed Description
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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.

Official Title
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Functional and Clinical Long-Term Outcome of Ewing Sarcoma Treatment

Conditions
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Sarcoma, Ewing's

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CESS81/CESS86/EICESS92/EURO-E.W.I.N.G.99 trials participants of the German Society of Pediatric Hematology and Oncology (GPOH) Exclusion Criteria: no complete remission (CR) any kind of paralysis <3y after diagnosis

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>sarcoma survivors | |
| 2<br>healthy subjects | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical activity (SAM: step-activity-monitor) |  | 3-30years after primary diagnosis of Ewing sarcoma | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| health-related quality of life (SF36, PEDQOL) |  | 3-30years after primary diagnosis of Ewing sarcoma | 
| functional status (TESS) |  | 3-30years after primary diagnosis of Ewing sarcoma | 
| psychological status (HADS, BIS-BAS) |  | 3-30years after primary diagnosis of Ewing sarcoma | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone tumors, long-term function, daily activity, late sequelae