Transcultural Validation of MSTS and TESS Questionnaire

Cancer Clinical Trial

— MSTS-TESS  

Official title:

Transcultural Validation of MSTS and TESS Questionnaire

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03765970
• Other study ID #: RC17_0487
• Status: Recruiting
• Start date: January 21, 2019
• Est. completion date: December 2019

Study information

• Verified date: June 2018
• Source: Nantes University Hospital
• Contact: Kevin BRULEFERT, Dr
• Phone: 0240082211
• Email: Kevin.brulefert[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
France	Marseille University Hospital	Marseille
France	Nantes University hospital	Nantes
France	Nantes University Hospital	Nantes
France	Rennes University Hospital	Rennes
France	Tours University Hospital	Tours

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of psychometric properties of questionnaire MSTS in French translation		one day
Secondary	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
Secondary	Define face validity : evaluate the comprehension of the questionnaire by 5 to 10 patients (qualitative analysis)		one day
Secondary	Define questionnaires construction validity: coherent evolution of scoring with the clinical status of the patients (ANOVA)		3 months (after study completion)
Secondary	Define criteria validity: coherence with other scores (correlation with WOMAC-long form >0.4)		one day
Secondary	Define score reliability: intern coherence and responses coherence (Cronbach's alpha > 0.7 and Loevinger's H > 0.3)		3 months (after study completion)
Secondary	Verify the repeatability of the questionnaire MSTS on 30 to 50 patients : concordance between answers of two surgeons on the same consultation		one day
Secondary	Define criteria validity for upper limbs: coherence with DASH score (correlation with DASH >0.4)		one day
Secondary	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