⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Transcultural Validation of MSTS and TESS Questionnaire

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Transcultural Validation of MSTS and TESS Questionnaire

Official Title: Transcultural Validation of MSTS and TESS Questionnaire

Study ID: NCT03765970

Conditions

Cancer

Interventions

Study Description

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.

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.

Eligibility

Minimum Age: 15 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Marseille University Hospital, Marseille, , France

Nantes University hospital, Nantes, , France

Nantes University Hospital, Nantes, , France

Rennes University Hospital, Rennes, , France

Tours University Hospital, Tours, , France

Contact Details

Name: Kevin BRULEFERT, Dr

Affiliation: Nantes University Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: