Clinical trial · Observational
Transcultural Validation of MSTS and TESS Questionnaire
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Validation of psychometric properties of questionnaire MSTS in French translation
- timeFrame
- one day
Secondary outcomes (8)
- measure
- Define questionnaires content validity : evaluation of translation quality (expert consensus).
- timeFrame
- one day
- description
- After the 2 translations and retrotranslations of the questionnaires adapted to the present time and the target population, an expert committee composed of health professionals meets with the aim of proposing a unified version. This latest version is subject to the approval of the original authors.
- measure
- Define face validity : evaluate the comprehension of the questionnaire by 5 to 10 patients (qualitative analysis)
- timeFrame
- one day
- measure
- Define questionnaires construction validity: coherent evolution of scoring with the clinical status of the patients (ANOVA)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
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 Exclusion Criteria: * Patients refusing to participate * Patient under guardianship * Patient inappropriate for entry into this study according to the judgment of the investigator
References
Publications (0)
Data not yet available