Clinical trial NCT03765970: Transcultural Validation of MSTS and TESS Questionnaire
Official title: Transcultural Validation of MSTS and TESS Questionnaire
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: Tumor resection
MSTS
TESS
Soft tissue and bone
Questionnaires
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Angers
First posted: 2018-12-05
Enrollment: 250
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population is adults and adolescents aged 15 and over operated on tumor surgery that can lead to functional sequelae.

These patients will be evaluated at the post-surgical consultation or during a consultation of followed regardless of the seniority of the surgery.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Validation of psychometric properties of questionnaire MSTS in French translation
timeFrame: one day
Secondary outcomes:
measure: Define questionnaires content validity : evaluation of translation quality (expert consensus).
timeFrame: one day
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)
timeFrame: 3 months (after study completion)
measure: Define criteria validity: coherence with other scores (correlation with WOMAC-long form >0.4)
timeFrame: one day
measure: Define score reliability: intern coherence and responses coherence (Cronbach's alpha > 0.7 and Loevinger's H > 0.3)
timeFrame: 3 months (after study completion)
measure: Verify the repeatability of the questionnaire MSTS on 30 to 50 patients : concordance between answers of two surgeons on the same consultation
timeFrame: one day
measure: Define criteria validity for upper limbs: coherence with DASH score (correlation with DASH >0.4)
timeFrame: one day
measure: 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).
timeFrame: two weeks
Other outcomes:
Locations:
city: Marseille
country: France
facility: Marseille University Hospital
city: Nantes
country: France
facility: Nantes University hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Tours
country: France
facility: Tours University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Kevin BRULEFERT, Dr
role: PRINCIPAL_INVESTIGATOR
References: