Sarcoma
Conditions
Brief summary
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.
Interventions
OTHERsurvey
Quality of life survey and motor performace survey
Sponsors
Fondazione Don Carlo Gnocchi Onlus
Fondazione Policlinico Universitario Campus Bio-Medico
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
\- Adult patients affected by primary localized soft tissue sarcoma, candidate to limb/trunk surgery with wide excision or retroperitoneal resection (including resection of the iliopsoas muscle with possible damage to the femoral nerve) with curative intent.
Exclusion criteria
* Patients with recurrent tumors; * patients with metastatic disease; * patients with palliative surgery; * patients with amputations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in the Toronto Extremity Salvage Score (TESS) | T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery) | a change in the TESS greater than 7 points |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain evaluation | T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery) | Brief Pain Questionnaire |
| Motor performance evaluation | T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery) | Musculoskeletal Tumor Society Rating Scale |
| Evaluation of Quality of Life | T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery) | Quality-of-Life Questionnaire (QLQ)-C30 |
Countries
Italy
Contacts
Primary ContactSergio Valeri
Outcome results
None listed