Informations générales (source: ClinicalTrials.gov)
Transcultural Validation of MSTS and TESS Questionnaire (MSTS-TESS)
Observational
Nantes University Hospital (Voir sur ClinicalTrials)
janvier 2019
décembre 2019
29 juin 2024
Reference treatment for soft tissue or bone sarcoma is the Monobloc resection surgery,
with a margin of one to many millimeters removing the entire tumor leaving no cancer
cells, associated or not with other treatments. Other musculoskeletal malignant tumors,
some of them with secondary origins (metastases), are treated the same way. Patients with
soft tissue and bone tumor could have heavy sequels of this surgery procedure, depending
on the localization and size of the initial tumor. Those functional sequels are evaluated
by specific questionnaires: the questionnaire TESS for upper limbs and TESS for lower
limbs which are completed by the patient (depending on the localization of the tumor) and
the questionnaire MSTS which is completed by the medical doctor.
Those English validated questionnaires are frequently used by French surgeons in standard
practice as well as scientific research. The translations done have never been validated
by an official methodology.
The aim of this trial is to validate the TESS and MSTS questionnaires linguistically,
culturally (questions must be adapted for each target population: occidental adults and
adolescents population, male and female population and adapted to the current era), and
scientifically (repeatability).
The validation of those questionnaires will permit to have functional and reference
questionnaires in French language which could be used for the follow up of operated
patient in the context of the care and clinical research.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Nantes University hospital - 44093 - Nantes - France | Antoine Hamel, Pr | Contact (sur clinicalTrials) | |||
| Rennes University Hospital - 35000 - Rennes - France | Mickaël Ropars, Pr | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Marseille University Hospital - 13015 - Marseille - France | Jean-Camille Mattei, Dr | Contact (sur clinicalTrials) | |||
| Tours University Hospital - 37044 - Tours - France | Philippe Rosset, Pr | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Major Patients who has accepted and be informed of the protocol or minor patient
over 15 years old who has accepted and be informed of the protocol, with the
agreement of one legal representative
- Patients over 15 years old who had a surgical procedure for a musculoskeletal tumor
which could result in functional sequels. (at the appreciation of the surgeon)
- Patients in the capacity to answer and understand the questionnaire and for whom the
French is the native language
- Major Patients who has accepted and be informed of the protocol or minor patient
over 15 years old who has accepted and be informed of the protocol, with the
agreement of one legal representative
- Patients over 15 years old who had a surgical procedure for a musculoskeletal tumor
which could result in functional sequels. (at the appreciation of the surgeon)
- Patients in the capacity to answer and understand the questionnaire and for whom the
French is the native language
- Patients refusing to participate
- Patient under guardianship
- Patient inappropriate for entry into this study according to the judgment of the
investigator