Transcultural Validation of MSTS and TESS Questionnaire (MSTS-TESS)

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.

Study Overview

• Status: Unknown
• Conditions: Cancer

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.

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Kevin BRULEFERT, Dr; Phone Number: 0240082211; Email: Kevin.brulefert@chu-nantes.fr

Study Locations

• France
  • Marseille, France, 13015
    • Not yet recruiting
    • Marseille University Hospital
    • Contact: Jean-Camille Mattei, Dr; Phone Number: 0491966299; Email: jeancamille.mattei@gmail.com
    • Principal Investigator: Jean-Camille Mattei, Dr
  • Nantes, France, 44093
    • Recruiting
    • Nantes University Hospital
    • Contact: Antoine Hamel, Pr; Phone Number: 0240083586; Email: antoine.hamel@chu-nantes.fr
    • Sub-Investigator: Antoine Hamel, Pr
  • Rennes, France, 35000
    • Not yet recruiting
    • Rennes University Hospital
    • Contact: Mickaël Ropars, Pr; Phone Number: 0622485909; Email: mickael.ropars@chu-rennes.fr
    • Principal Investigator: Mickaël Ropars, Pr
  • Tours, France, 37044
    • Not yet recruiting
    • Tours University Hospital
    • Contact: Philippe Rosset, Pr; Phone Number: 0607386846; Email: philippe.rosset@orange.fr
    • Principal Investigator: Philippe Rosset, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Validation of psychometric properties of questionnaire MSTS in French translation	one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Define questionnaires content validity : evaluation of translation quality (expert consensus).	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.	one day
Define face validity : evaluate the comprehension of the questionnaire by 5 to 10 patients (qualitative analysis)		one day
Define questionnaires construction validity: coherent evolution of scoring with the clinical status of the patients (ANOVA)		3 months (after study completion)
Define criteria validity: coherence with other scores (correlation with WOMAC-long form >0.4)		one day
Define score reliability: intern coherence and responses coherence (Cronbach's alpha > 0.7 and Loevinger's H > 0.3)		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		one day
Define criteria validity for upper limbs: coherence with DASH score (correlation with DASH >0.4)		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).		two weeks

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: University Hospital, Angers
• Investigators: Principal Investigator: Kevin BRULEFERT, Dr, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 21, 2019
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (ACTUAL): December 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 2019
• Last Update Submitted That Met QC Criteria: March 14, 2019
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Questionnaires; TESS; Tumor resection; MSTS; Soft tissue and bone
• Other Study ID Numbers: RC17_0487

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No