Actively Recruiting

All Genders
NCT06282237

Clinical Evaluation, Motor Performance and Quality of Life in Patients Affected by Soft Tissue Sarcomas, Undergoing Surgical Treatment: Observational Study

Led by Fondazione Policlinico Universitario Campus Bio-Medico · Updated on 2024-02-28

13

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

Sponsors

F

Fondazione Policlinico Universitario Campus Bio-Medico

Lead Sponsor

F

Fondazione Don Carlo Gnocchi Onlus

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Clinical Evaluation, Motor Performance and Quality of Life in Patients Affected by Soft Tissue Sarcomas, Undergoing Surgical Treatment: Observational Study

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients affected by primary localized soft tissue sarcoma
  • Candidates for limb or trunk surgery with wide excision or retroperitoneal resection, including iliopsoas muscle resection
  • Surgery performed with curative intent
Not Eligible

You will not qualify if you...

  • Patients with recurrent tumors
  • Patients with metastatic disease
  • Patients undergoing palliative surgery
  • Patients with amputations

AI-Screening

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Trial Site Locations

Total: 1 location

1

Fondazione Policlinico Campus Biomedico

Roma, Italy, 00128

Actively Recruiting

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Research Team

S

Sergio Valeri

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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