The primary objective is to measure the real-world daily activity in a representative cohort of 1100 longterm survivors after Ewing tumor treatment using portable devices, and to describe the functional outcome and health-related quality of life…
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The results will be used to identify those changes in functional capacity that
likely result in long-term physical, intellectual, or psychological problems,
and to develop strategies for reducing long-term effects of different
therapeutic approaches.
Secondary outcome
The secondary objective is to establish and upgrade a unique data pool of 2700
Ewing patients that allows to perform differential analyses of diagnostic,
treatment, and follow-up data from childhood cancer patients covering a period
of 30 years. Prognostic factors for long-term survival will be obtained. Risk
ratios for survival between treatment options will be computed to combine
long-term functional and survival outcome results. Guidelines for future
treatment practice and long-term follow-up will be provided.
Background summary
Ewing tumors are the second most common bone tumors in childhood and
adolescence. The short-term clinical outcome is well known with about 70%
surviving, however, valid information on the long-term functional outcome is
very limited. To minimize the clinical, economic and social late effects of
treatment it is necessary to examine long-term survivors with objective and
self-report instruments.
Study objective
The primary objective is to measure the real-world daily activity in a
representative cohort of 1100 longterm survivors after Ewing tumor treatment
using portable devices, and to describe the functional outcome and
health-related quality of life associated with different chemotherapeutic
regimens and local surgical and radiotherapeutic techniques. All scores will be
compared to a peer control group of equal size matched according to age, sex
and other potential bias factors.
Study design
Included patients will be asked to fill in a questionaire based on the Toronto
Extermity Salvage Score, the MOS Short Form Healty Survey SF36 (patients> 18
years) and the PEDQL (for patients < 18 years) of age and the Rosenberg self
esteem score, the EORTC modules about body image and sexuals qualitiy
functioning. Functional activity will be measured by wearing a Cyma Step
Activity Monitor around the ankle for 14 days during daytime. Survival analyses
will be done on all patients to build the basis for evaluating functional
outcome in relation to survival probabilities and their co-variation relative
to different therapy approaches. For every long-term survivor one peer of the
patient will be recruited to control for potential bias factors
Study burden and risks
Burden will be
1. Filling in a single questionnaire
2. wearing a strap around the ankle for 14 days (except during nighttimes and
during bathing routines.
Risks
1. circulation problem in case the strap is fitted to tight.
Benefits;
1. Prognostic factors for long-term survival will be obtained.
2.Risk ratios for survival between treatment options will be computed to
combine long-term functional and
survival outcome results.
3.Guidelines for future treatment practice and long-term follow-up will be
provided.
Meibergdreef 9
1105AZ Amsterdam
NL
Meibergdreef 9
1105AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
This is a cohort study that will include all patients with histologically confirmed Ewing tumor of the
previous CESS 81, CESS 86, EICESS 92 and ongoing EURO-E.W.I.N.G. 99 (expected closing date end of 2008) of the German Society for Pediatric Oncology and Hematology (GPOH). Additionally, all Ewing tumor patients will be included who have been registered as follow-up patients to the Ewing tumor trail center in Münster from 150 participating institutions in Germany and about 30 additional centers in the neighboring countries. (Among them the AMC)
Exclusion criteria
Patients with any kind of paralysis will be excluded from the functional measurement (<1%) as the daily activity could not objectively be measured with step monitors.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL34483.018.10 |