Clinical trial NCT06282237: Clinical Evaluation, Motor Performance and Quality of Life in Patients Affected by Soft Tissue Sarcomas, Undergoing Surgical Treatment: Observational Study
Official title: Clinical Evaluation, Motor Performance and Quality of Life in Patients Affected by Soft Tissue Sarcomas, Undergoing Surgical Treatment: Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcoma
Lead sponsor: Fondazione Policlinico Universitario Campus Bio-Medico
Sponsor class: OTHER
Collaborators: name: Fondazione Don Carlo Gnocchi Onlus
First posted: 2024-02-28
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients candidates for surgery for soft tissue sarcoma and undergoing post-operative rehabilitation treatment.

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.


Eligibility 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.

Primary outcomes:
measure: Improvement in the Toronto Extremity Salvage Score (TESS)
timeFrame: T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)
Secondary outcomes:
measure: Pain evaluation
timeFrame: T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)
measure: Motor performance evaluation
timeFrame: T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)
measure: Evaluation of Quality of Life
timeFrame: T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)
measure: Pain evaluation
timeFrame: T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)
measure: Pain evaluation
timeFrame: T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)
measure: Evaluation of Quality of Life
timeFrame: T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Campus Biomedico
Study officials:
affiliation: FPU CampusBioMedico
name: Sergio Valeri
role: PRINCIPAL_INVESTIGATOR
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