Transcultural Validation of MSTS and TESS Questionnaire

NCT03765970 | Unknown

• 1 other identifier: RC17_0487
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 5

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.

Conditions

Cancer

Keywords

Tumor resection; MSTS; TESS; Soft tissue and bone; Questionnaires

Outcome Measures

Primary Outcomes (1)

• Validation of psychometric properties of questionnaire MSTS in French translation

  one day

Secondary Outcomes (8)

• Define questionnaires content validity : evaluation of translation quality (expert consensus).

  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)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients refusing to participate
• Patient under guardianship
• Patient inappropriate for entry into this study according to the judgment of the investigator

Sponsors & Collaborators

• Nantes University Hospital: lead
• University Hospital, Angers: collaborator

Study Sites (5)

Marseille University Hospital

Marseille, 13015, France

NOT YET RECRUITING

Nantes University hospital

Nantes, 44093, France

RECRUITING

Nantes University Hospital

Nantes, 44093, France

RECRUITING

Rennes University Hospital

Rennes, 35000, France

NOT YET RECRUITING

Tours University Hospital

Tours, 37044, France

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Kevin BRULEFERT, Dr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin BRULEFERT, Dr

CONTACT

0240082211; Kevin.brulefert@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: December 5, 2018
• Study Start: January 21, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 18, 2019

Record last verified: 2018-06

Locations

FR (5)