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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
University Hospital, Angers
Information provided by (Responsible Party):
Nantes University Hospital

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.


Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. Validation of psychometric properties of questionnaire MSTS in French translation [ Time Frame: one day ]

Secondary Outcome Measures :
  1. 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.

  2. Define face validity : evaluate the comprehension of the questionnaire by 5 to 10 patients (qualitative analysis) [ Time Frame: one day ]
  3. Define questionnaires construction validity: coherent evolution of scoring with the clinical status of the patients (ANOVA) [ Time Frame: 3 months (after study completion) ]
  4. Define criteria validity: coherence with other scores (correlation with WOMAC-long form >0.4) [ Time Frame: one day ]
  5. 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) ]
  6. 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 ]
  7. Define criteria validity for upper limbs: coherence with DASH score (correlation with DASH >0.4) [ Time Frame: one day ]
  8. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

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


Contacts
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Contact: Kevin BRULEFERT, Dr 0240082211 Kevin.brulefert@chu-nantes.fr

Locations
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France
Marseille University Hospital Not yet recruiting
Marseille, France, 13015
Contact: Jean-Camille Mattei, Dr    0491966299    jeancamille.mattei@gmail.com   
Principal Investigator: Jean-Camille Mattei, Dr         
Nantes University hospital Recruiting
Nantes, France, 44093
Contact: Kevin BRULEFERT, Dr    0240082211    Kevin.brulefert@chu-nantes.fr   
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    antoine.hamel@chu-nantes.fr   
Sub-Investigator: Antoine Hamel, Pr         
Rennes University Hospital Not yet recruiting
Rennes, France, 35000
Contact: Mickaël Ropars, Pr    0622485909    mickael.ropars@chu-rennes.fr   
Principal Investigator: Mickaël Ropars, Pr         
Tours University Hospital Not yet recruiting
Tours, France, 37044
Contact: Philippe Rosset, Pr    0607386846    philippe.rosset@orange.fr   
Principal Investigator: Philippe Rosset, Pr         
Sponsors and Collaborators
Nantes University Hospital
University Hospital, Angers
Investigators
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Principal Investigator: Kevin BRULEFERT, Dr Nantes University Hospital
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03765970    
Other Study ID Numbers: RC17_0487
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Tumor resection
MSTS
TESS
Soft tissue and bone
Questionnaires