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

NCT06282237 | Recruiting

• 1 other identifier: 2022.143
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Pain evaluation

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

• Motor performance evaluation

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

• Evaluation of Quality of Life

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

• Pain evaluation

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

• Pain evaluation

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

Interventions

survey OTHER

Quality of life survey and motor performace survey

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \- 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.

You may not qualify if:

• Patients with recurrent tumors;
• patients with metastatic disease;
• patients with palliative surgery;
• patients with amputations.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Campus Bio-Medico: lead
• Fondazione Don Carlo Gnocchi Onlus: collaborator

Study Sites (1)

Fondazione Policlinico Campus Biomedico

Roma, 00128, Italy

RECRUITING

Related Publications (17)

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  PMID: 11323136 RESULT

• 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.

  PMID: 10201543 RESULT

• 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.

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• 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.

  PMID: 19913388 RESULT

• 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.

  PMID: 8826494 RESULT

• 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.

  PMID: 8973131 RESULT

• 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.

  PMID: 33082266 RESULT

• 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.

  PMID: 28442210 RESULT

• 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.

  PMID: 33740199 RESULT

• 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.

  PMID: 31407171 RESULT

• 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.

  PMID: 31000377 RESULT

• 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.

  PMID: 19198756 RESULT

• 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.

  PMID: 26364445 RESULT

• 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.

  PMID: 31957034 RESULT

• 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.

  PMID: 19282208 RESULT

• 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.

  PMID: 16000093 RESULT

• Demofonti A, Brunetti B, Germanotta M, Coppola MM, Falchini F, Valeri A, Tenna S, Valeri S, Aprile IG. Effects of a tailored rehabilitation treatment in lower limb Soft Tissue Sarcomas reconstruction: a case series. J Neuroeng Rehabil. 2026 Jan 21. doi: 10.1186/s12984-026-01878-y. Online ahead of print.

  PMID: 41566361 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Sergio Valeri

  FPU CampusBioMedico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergio Valeri

CONTACT

06225411626; s.valeri@policlinicocampus.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 28, 2024
• Study Start: July 1, 2023
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

IT (1)