About this trial
The main aim of the study is evaluate quality of life and motor performance of patients with soft tissue sarcomas undergoing surgical treatment and post-operative rehabilitation treatment.
Primary objectives:
* Identification of clinical characteristics and motor damage after surgery for soft tissue sarcomas; * Impact of perioperative treatments and surgery on the quality of life of patients with soft tissue sarcomas; * Impact of post-operative rehabilitation treatment on quality of life and recovery of motor activity The primary endpoint will be the improvement in the Toronto Extremity Salvage Score (TESS) between T1 (post-surgery) and T3 (at the end of rehabilitation treatment).
Secondary endpoints will be:
1\. the evolution over the various timepoints of the selected rating scales (Toronto Extremity Salvage Score, Musculoskeletal Tumor Society Rating Scale, Numerical Rating Scale, Brief Pain Questionnaire, Douleur Neuropathique en 4 Questions, Leeds Assessment of Neuropathic Symptoms and Signs Scale, European Organization for Research and Treatment of Cancer, Quality-of-Life Questionnaire (QLQ)-C30, Short Form Health Survey 36);
• The change in walking performance before and after the rehabilitation treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Patients with recurrent tumors;
patients with metastatic disease;
patients with palliative surgery;
patients with amputations.
Trial population
Patients candidates for surgery for soft tissue sarcoma and undergoing post-operative rehabilitation treatment.
Trial design
Other
Prospective
Treatments tested in this trial
survey
Other interventionQuality of life survey and motor performace survey
Treatment groups
Trial outcomes
Primary outcomes
Improvement in the Toronto Extremity Salvage Score (TESS)
a change in the TESS greater than 7 points
Secondary outcomes
Pain evaluation
Brief Pain Questionnaire
Motor performance evaluation
Musculoskeletal Tumor Society Rating Scale
Evaluation of Quality of Life
Quality-of-Life Questionnaire (QLQ)-C30
Pain evaluation
Douleur Neuropathique en 4 Questions
Sponsors and contacts
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Fondazione Policlinico Universitario Campus Bio-Medico
Lead sponsor
Fondazione Don Carlo Gnocchi Onlus
Collaborator