<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03765970</url>
  </required_header>
  <id_info>
    <org_study_id>RC17_0487</org_study_id>
    <nct_id>NCT03765970</nct_id>
  </id_info>
  <brief_title>Transcultural Validation of MSTS and TESS Questionnaire</brief_title>
  <acronym>MSTS-TESS</acronym>
  <official_title>Transcultural Validation of MSTS and TESS Questionnaire</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Reference treatment for soft tissue or bone sarcoma is the Monobloc resection surgery, with a&#xD;
      margin of one to many millimeters removing the entire tumor leaving no cancer cells,&#xD;
      associated or not with other treatments. Other musculoskeletal malignant tumors, some of them&#xD;
      with secondary origins (metastases), are treated the same way. Patients with soft tissue and&#xD;
      bone tumor could have heavy sequels of this surgery procedure, depending on the localization&#xD;
      and size of the initial tumor. Those functional sequels are evaluated by specific&#xD;
      questionnaires: the questionnaire TESS for upper limbs and TESS for lower limbs which are&#xD;
      completed by the patient (depending on the localization of the tumor) and the questionnaire&#xD;
      MSTS which is completed by the medical doctor.&#xD;
&#xD;
      Those English validated questionnaires are frequently used by French surgeons in standard&#xD;
      practice as well as scientific research. The translations done have never been validated by&#xD;
      an official methodology.&#xD;
&#xD;
      The aim of this trial is to validate the TESS and MSTS questionnaires linguistically,&#xD;
      culturally (questions must be adapted for each target population: occidental adults and&#xD;
      adolescents population, male and female population and adapted to the current era), and&#xD;
      scientifically (repeatability).&#xD;
&#xD;
      The validation of those questionnaires will permit to have functional and reference&#xD;
      questionnaires in French language which could be used for the follow up of operated patient&#xD;
      in the context of the care and clinical research.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The methodology will follow the guidelines of Dorcas E. Beaton, Claire Bombardier, Francis&#xD;
      Guillemin and Marcos Bosi Ferraz (approved in particular by the American Academy of&#xD;
      Orthopedic Surgeons):&#xD;
&#xD;
      Step 1: Author's agreement Step 2: Translation with cultural adaptation in addition to&#xD;
      literal translation Step 3: 2 first translations English to French (2 different translators&#xD;
      T1 and T2) Step 4: Synthesis (T12) Step 5: 2 reverse translations of T12 French to English&#xD;
      (BT1 and BT2) Step 6: Submission to a committee of experts of the final translation Step 7:&#xD;
      Clinical study based on a sample of patients (questionnaires, interview and analysis of the&#xD;
      distribution of responses) The investigators planned the recruitment of 250 adults and&#xD;
      adolescents patients over 15 years old, who will answers to the questionnaires (MSTS-TESS) as&#xD;
      well as control-questionnaires (WOMAC or DASH) during a follow-up consultation, in Nantes,&#xD;
      Rennes, Tours or Marseille centers. A study of repeatability will be performed with 30 to 50&#xD;
      patients for whom 2 filling will be necessary, the first time during the consultation and the&#xD;
      second time at home, 15 days later.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 21, 2019</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Validation of psychometric properties of questionnaire MSTS in French translation</measure>
    <time_frame>one day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Define questionnaires content validity : evaluation of translation quality (expert consensus).</measure>
    <time_frame>one day</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Define face validity : evaluate the comprehension of the questionnaire by 5 to 10 patients (qualitative analysis)</measure>
    <time_frame>one day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Define questionnaires construction validity: coherent evolution of scoring with the clinical status of the patients (ANOVA)</measure>
    <time_frame>3 months (after study completion)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Define criteria validity: coherence with other scores (correlation with WOMAC-long form &gt;0.4)</measure>
    <time_frame>one day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Define score reliability: intern coherence and responses coherence (Cronbach's alpha &gt; 0.7 and Loevinger's H &gt; 0.3)</measure>
    <time_frame>3 months (after study completion)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Verify the repeatability of the questionnaire MSTS on 30 to 50 patients : concordance between answers of two surgeons on the same consultation</measure>
    <time_frame>one day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Define criteria validity for upper limbs: coherence with DASH score (correlation with DASH &gt;0.4)</measure>
    <time_frame>one day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <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).</measure>
    <time_frame>two weeks</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Cancer</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The target population is adults and adolescents aged 15 and over operated on tumor surgery&#xD;
        that can lead to functional sequelae.&#xD;
&#xD;
        These patients will be evaluated at the post-surgical consultation or during a consultation&#xD;
        of followed regardless of the seniority of the surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major Patients who has accepted and be informed of the protocol or minor patient over&#xD;
             15 years old who has accepted and be informed of the protocol, with the agreement of&#xD;
             one legal representative&#xD;
&#xD;
          -  Patients over 15 years old who had a surgical procedure for a musculoskeletal tumor&#xD;
             which could result in functional sequels. (at the appreciation of the surgeon)&#xD;
&#xD;
          -  Patients in the capacity to answer and understand the questionnaire and for whom the&#xD;
             French is the native language&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients refusing to participate&#xD;
&#xD;
          -  Patient under guardianship&#xD;
&#xD;
          -  Patient inappropriate for entry into this study according to the judgment of the&#xD;
             investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin BRULEFERT, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Nantes University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kevin BRULEFERT, Dr</last_name>
    <phone>0240082211</phone>
    <email>Kevin.brulefert@chu-nantes.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Marseille University Hospital</name>
      <address>
        <city>Marseille</city>
        <zip>13015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jean-Camille Mattei, Dr</last_name>
      <phone>0491966299</phone>
      <email>jeancamille.mattei@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Jean-Camille Mattei, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nantes University hospital</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kevin BRULEFERT, Dr</last_name>
      <phone>0240082211</phone>
      <email>Kevin.brulefert@chu-nantes.fr</email>
    </contact>
    <investigator>
      <last_name>François Gouin, Pr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Denis Waast, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Vincent Crenn, Dr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Nantes University Hospital</name>
      <address>
        <city>Nantes</city>
        <zip>44093</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Antoine Hamel, Pr</last_name>
      <phone>0240083586</phone>
      <email>antoine.hamel@chu-nantes.fr</email>
    </contact>
    <investigator>
      <last_name>Antoine Hamel, Pr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rennes University Hospital</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Mickaël Ropars, Pr</last_name>
      <phone>0622485909</phone>
      <email>mickael.ropars@chu-rennes.fr</email>
    </contact>
    <investigator>
      <last_name>Mickaël Ropars, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tours University Hospital</name>
      <address>
        <city>Tours</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Philippe Rosset, Pr</last_name>
      <phone>0607386846</phone>
      <email>philippe.rosset@orange.fr</email>
    </contact>
    <investigator>
      <last_name>Philippe Rosset, Pr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>June 19, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>March 14, 2019</last_update_submitted>
  <last_update_submitted_qc>March 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tumor resection</keyword>
  <keyword>MSTS</keyword>
  <keyword>TESS</keyword>
  <keyword>Soft tissue and bone</keyword>
  <keyword>Questionnaires</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03765970
org study id: RC17_0487
nct id: NCT03765970
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Case-Only
time perspective: Prospective
measure: Validation of psychometric properties of questionnaire MSTS in French translation
time frame: one day
measure: Define questionnaires content validity : evaluation of translation quality (expert consensus).
time frame: one day
description: 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.
measure: Define face validity : evaluate the comprehension of the questionnaire by 5 to 10 patients (qualitative analysis)
time frame: one day
measure: Define questionnaires construction validity: coherent evolution of scoring with the clinical status of the patients (ANOVA)
time frame: 3 months (after study completion)
measure: Define criteria validity: coherence with other scores (correlation with WOMAC-long form >0.4)
time frame: one day
measure: 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)
measure: 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
measure: Define criteria validity for upper limbs: coherence with DASH score (correlation with DASH >0.4)
time frame: 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).
time frame: two weeks
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Kevin BRULEFERT, Dr
role: Principal Investigator
affiliation: Nantes University Hospital
last name: Kevin BRULEFERT, Dr
phone: 0240082211
email: Kevin.brulefert@chu-nantes.fr
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor