Transcultural Validation of MSTS and TESS Questionnaire (MSTS-TESS)
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|ClinicalTrials.gov Identifier: NCT03765970|
Recruitment Status : Unknown
Verified June 2018 by Nantes University Hospital.
Recruitment status was: Recruiting
First Posted : December 5, 2018
Last Update Posted : March 18, 2019
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.
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Transcultural Validation of MSTS and TESS Questionnaire|
|Actual Study Start Date :||January 21, 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
- Validation of psychometric properties of questionnaire MSTS in French translation [ Time Frame: one day ]
- Define questionnaires content validity : evaluation of translation quality (expert consensus). [ Time Frame: one day ]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.
- Define face validity : evaluate the comprehension of the questionnaire by 5 to 10 patients (qualitative analysis) [ Time Frame: one day ]
- Define questionnaires construction validity: coherent evolution of scoring with the clinical status of the patients (ANOVA) [ Time Frame: 3 months (after study completion) ]
- Define criteria validity: coherence with other scores (correlation with WOMAC-long form >0.4) [ Time Frame: one day ]
- Define score reliability: intern coherence and responses coherence (Cronbach's alpha > 0.7 and Loevinger's H > 0.3) [ Time Frame: 3 months (after study completion) ]
- Verify the repeatability of the questionnaire MSTS on 30 to 50 patients : concordance between answers of two surgeons on the same consultation [ Time Frame: one day ]
- Define criteria validity for upper limbs: coherence with DASH score (correlation with DASH >0.4) [ Time Frame: one day ]
- Verify the repeatability of the questionnaire TESS on 30 to 50 patients: concordance between answers of the same patient completing twice the same questionnaires (first during the consultation and then 15 days after at home). [ Time Frame: two weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03765970
|Contact: Kevin BRULEFERT, Dr||0240082211||Kevin.email@example.com|
|Marseille University Hospital||Not yet recruiting|
|Marseille, France, 13015|
|Contact: Jean-Camille Mattei, Dr 0491966299 firstname.lastname@example.org|
|Principal Investigator: Jean-Camille Mattei, Dr|
|Nantes University hospital||Recruiting|
|Nantes, France, 44093|
|Contact: Kevin BRULEFERT, Dr 0240082211 Kevin.email@example.com|
|Sub-Investigator: François Gouin, Pr|
|Sub-Investigator: Denis Waast, Dr|
|Sub-Investigator: Vincent Crenn, Dr|
|Nantes University Hospital||Recruiting|
|Nantes, France, 44093|
|Contact: Antoine Hamel, Pr 0240083586 firstname.lastname@example.org|
|Sub-Investigator: Antoine Hamel, Pr|
|Rennes University Hospital||Not yet recruiting|
|Rennes, France, 35000|
|Contact: Mickaël Ropars, Pr 0622485909 email@example.com|
|Principal Investigator: Mickaël Ropars, Pr|
|Tours University Hospital||Not yet recruiting|
|Tours, France, 37044|
|Contact: Philippe Rosset, Pr 0607386846 firstname.lastname@example.org|
|Principal Investigator: Philippe Rosset, Pr|
|Principal Investigator:||Kevin BRULEFERT, Dr||Nantes University Hospital|