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

ConditionSarcoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorFondazione Policlinico Universitario Campus Bio-Medico

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • survey

    Other intervention

    Quality of life survey and motor performace survey

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Improvement in the Toronto Extremity Salvage Score (TESS)

a change in the TESS greater than 7 points

Time frame
T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)

Secondary outcomes

1

Pain evaluation

Brief Pain Questionnaire

Time frame
T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)
2

Motor performance evaluation

Musculoskeletal Tumor Society Rating Scale

Time frame
T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)
3

Evaluation of Quality of Life

Quality-of-Life Questionnaire (QLQ)-C30

Time frame
T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)
4

Pain evaluation

Douleur Neuropathique en 4 Questions

Time frame
T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Policlinico Universitario Campus Bio-Medico

Lead sponsor

Fondazione Don Carlo Gnocchi Onlus

Collaborator