Cancer Clinical Trial
Official title:
Transcultural Validation of MSTS and TESS Questionnaire
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.
The methodology will follow the guidelines of Dorcas E. Beaton, Claire Bombardier, Francis
Guillemin and Marcos Bosi Ferraz (approved in particular by the American Academy of
Orthopedic Surgeons):
Step 1: Author's agreement Step 2: Translation with cultural adaptation in addition to
literal translation Step 3: 2 first translations English to French (2 different translators
T1 and T2) Step 4: Synthesis (T12) Step 5: 2 reverse translations of T12 French to English
(BT1 and BT2) Step 6: Submission to a committee of experts of the final translation Step 7:
Clinical study based on a sample of patients (questionnaires, interview and analysis of the
distribution of responses) The investigators planned the recruitment of 250 adults and
adolescents patients over 15 years old, who will answers to the questionnaires (MSTS-TESS) as
well as control-questionnaires (WOMAC or DASH) during a follow-up consultation, in Nantes,
Rennes, Tours or Marseille centers. A study of repeatability will be performed with 30 to 50
patients for whom 2 filling will be necessary, the first time during the consultation and the
second time at home, 15 days later.
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