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Trial Title:
Clinical Evaluation, Motor Performance and Quality of Life in Patients Affected by Soft Tissue Sarcomas, Undergoing Surgical Treatment: Observational Study
NCT ID:
NCT06282237
Condition:
Sarcoma
Conditions: Official terms:
Sarcoma
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
survey
Description:
Quality of life survey and motor performace survey
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.
Criteria for eligibility:
Study pop:
Patients candidates for surgery for soft tissue sarcoma and undergoing post-operative
rehabilitation treatment.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione Policlinico Campus Biomedico
Address:
City:
Roma
Zip:
00128
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Sergio Valeri, MD
Phone:
06225411626
Email:
s.valeri@policlinicocampus.it
Start date:
July 1, 2023
Completion date:
July 1, 2026
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Campus Bio-Medico
Agency class:
Other
Collaborator:
Agency:
Fondazione Don Carlo Gnocchi Onlus
Agency class:
Other
Source:
Fondazione Policlinico Universitario Campus Bio-Medico
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06282237
