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

Sarcoma Clinical Trial

— 1206  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06282237
• Other study ID #: 2022.143
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: July 1, 2026

Study information

• Verified date: February 2024
• Source: Fondazione Policlinico Universitario Campus Bio-Medico
• Contact: Sergio Valeri
• Phone: 06225411626
• Email: s.valeri[@]policlinicocampus.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Sarcoma

Intervention

Other:
• survey
Quality of life survey and motor performace survey

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Campus Biomedico	Roma

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Campus Bio-Medico	Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

References & Publications (16)

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. — View Citation

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. — View Citation

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.2 — View Citation

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.20 — View Citation

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; — View Citation

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. — View Citation

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. ESM — View Citation

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. — View Citation

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: 10.124 — View Citation

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. — View Citation

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 lowe — View Citation

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 o — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain evaluation	Brief Pain Questionnaire	T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)
Secondary	Motor performance evaluation	Musculoskeletal Tumor Society Rating Scale	T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)
Secondary	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)
Secondary	Pain evaluation	Douleur Neuropathique en 4 Questions	T0 (1 week before surgery) T1 (1 week post-surgery) and T3 (3 months post-surgery)
Secondary	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)
Secondary	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)