Clinical Evaluation, Motor Performance and Quality of Life in Patients Affected by Soft Tissue Sarcomas, Undergoing Surgical Treatment: Observational Study (1206)

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcoma
• Intervention / Treatment: Other: survey

• Study Type: Observational
• Enrollment (Estimated): 13

Contacts and Locations

• Study Contact: Name: Sergio Valeri; Phone Number: 06225411626; Email: s.valeri@policlinicocampus.it

Study Locations

• Italy
  • Roma, Italy, 00128
    • Recruiting
    • Fondazione Policlinico Campus BioMedico
    • Contact: Sergio Valeri, MD; Phone Number: 06225411626; Email: s.valeri@policlinicocampus.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients candidates for surgery for soft tissue sarcoma and undergoing post-operative rehabilitation treatment.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in the Toronto Extremity Salvage Score (TESS)	a change in the TESS greater than 7 points	T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain evaluation	Brief Pain Questionnaire	T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)
Motor performance evaluation	Musculoskeletal Tumor Society Rating Scale	T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)
Evaluation of Quality of Life	Quality-of-Life Questionnaire (QLQ)-C30	T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)
Pain evaluation	Douleur Neuropathique en 4 Questions	T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)
Pain evaluation	Leeds Assessment of Neuropathic Symptoms and Signs Scale	T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)
Evaluation of Quality of Life	Short Form Health Survey 36	T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico
• Collaborators: Fondazione Don Carlo Gnocchi Onlus
• Investigators: Principal Investigator: Sergio Valeri, FPU CampusBioMedico

Publications and helpful links

General Publications

• Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
• Bouhassira D, Attal N, Fermanian J, Alchaar H, Gautron M, Masquelier E, Rostaing S, Lanteri-Minet M, Collin E, Grisart J, Boureau F. Development and validation of the Neuropathic Pain Symptom Inventory. Pain. 2004 Apr;108(3):248-257. doi: 10.1016/j.pain.2003.12.024.
• Bennett M. The LANSS Pain Scale: the Leeds assessment of neuropathic symptoms and signs. Pain. 2001 May;92(1-2):147-57. doi: 10.1016/s0304-3959(00)00482-6.
• Cacchio A, De Blasis E, Necozione S, Rosa F, Riddle DL, di Orio F, De Blasis D, Santilli V. The Italian version of the lower extremity functional scale was reliable, valid, and responsive. J Clin Epidemiol. 2010 May;63(5):550-7. doi: 10.1016/j.jclinepi.2009.08.001. Epub 2009 Nov 12.
• Caraceni A, Mendoza TR, Mencaglia E, Baratella C, Edwards K, Forjaz MJ, Martini C, Serlin RC, de Conno F, Cleeland CS. A validation study of an Italian version of the Brief Pain Inventory (Breve Questionario per la Valutazione del Dolore). Pain. 1996 Apr;65(1):87-92. doi: 10.1016/0304-3959(95)00156-5.
• Davis AM, Wright JG, Williams JI, Bombardier C, Griffin A, Bell RS. Development of a measure of physical function for patients with bone and soft tissue sarcoma. Qual Life Res. 1996 Oct;5(5):508-16. doi: 10.1007/BF00540024.
• den Hollander D, Van der Graaf WTA, Fiore M, Kasper B, Singer S, Desar IME, Husson O. Unravelling the heterogeneity of soft tissue and bone sarcoma patients' health-related quality of life: a systematic literature review with focus on tumour location. ESMO Open. 2020 Oct;5(5):e000914. doi: 10.1136/esmoopen-2020-000914.
• Gerrand C, Furtado S. Issues of Survivorship and Rehabilitation in Soft Tissue Sarcoma. Clin Oncol (R Coll Radiol). 2017 Aug;29(8):538-545. doi: 10.1016/j.clon.2017.04.001. Epub 2017 Apr 22.
• Kask G, Repo JP, Tukiainen EJ, Blomqvist C, Barner-Rasmussen I. Soft Tissue Sarcoma of Lower Extremity: Functional Outcome and Quality of Life. Ann Surg Oncol. 2021 Oct;28(11):6892-6905. doi: 10.1245/s10434-021-09774-6. Epub 2021 Mar 19.
• Kask G, Barner-Rasmussen I, Repo JP, Kjaldman M, Kilk K, Blomqvist C, Tukiainen EJ. Functional Outcome Measurement in Patients with Lower-Extremity Soft Tissue Sarcoma: A Systematic Literature Review. Ann Surg Oncol. 2019 Dec;26(13):4707-4722. doi: 10.1245/s10434-019-07698-w. Epub 2019 Aug 12.
• Ogura K, Uehara K, Akiyama T, Shinoda Y, Iwata S, Tsukushi S, Kobayashi E, Hirose T, Yonemoto T, Endo M, Tanzawa Y, Nakatani F, Kawano H, Tanaka S, Kawai A. Minimal clinically important differences in Toronto Extremity Salvage Score for patients with lower extremity sarcoma. J Orthop Sci. 2020 Mar;25(2):315-318. doi: 10.1016/j.jos.2019.03.022. Epub 2019 Apr 16.
• Padua L, Briani C, Jann S, Nobile-Orazio E, Pazzaglia C, Morini A, Mondelli M, Ciaramitaro P, Cavaletti G, Cocito D, Fazio R, Santoro L, Galeotti F, Carpo M, Plasmati R, Benedetti L, Schenone A, Marchettini P, Cruccu G. Validation of the Italian version of the Neuropathic Pain Symptom Inventory in peripheral nervous system diseases. Neurol Sci. 2009 Apr;30(2):99-106. doi: 10.1007/s10072-009-0025-y. Epub 2009 Feb 6.
• Sartorio F, Moroso M, Vercelli S, Bravini E, Medina ME, Spalek R, Ferriero G. [CROSS-CULTURAL ADAPTATION, AND VALIDITY OF THE ITALIAN VERSION OF THE UPPER LiMB FUNCTIONAL INDEx (ULFI-I)]. G Ital Med Lav Ergon. 2015 Apr-Jun;37(2):115-9. Italian.
• Rossi L, Boffano M, Comandone A, Ferro A, Grignani G, Linari A, Pellegrino P, Piana R, Ratto N, Davis AM. Validation process of Toronto Exremity Salvage Score in Italian: A quality of life measure for patients with extremity bone and soft tissue tumors. J Surg Oncol. 2020 Mar;121(4):630-637. doi: 10.1002/jso.25849. Epub 2020 Jan 19.
• Van Seventer R, Vos C, Meerding W, Mear I, Le Gal M, Bouhassira D, Huygen FJ. Linguistic validation of the DN4 for use in international studies. Eur J Pain. 2010 Jan;14(1):58-63. doi: 10.1016/j.ejpain.2009.01.005. Epub 2009 Mar 17.
• Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin Nurs. 2005 Aug;14(7):798-804. doi: 10.1111/j.1365-2702.2005.01121.x.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Estimated): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma
• Other Study ID Numbers: 2022.143

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No