Quality of Life of Patients With Bone Tumor of the Lower Limbs Treated With Salvage Surgery

NCT05772312 | Completed DMC

• 1 other identifier: 5000
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to describe, through a minimum follow-up of 18 months, the quality of life of patients undergoing salvage surgery of lower limb for musculoskeletal tumors and to identify possible prognostic factor correlated. Quality of life will be evaluated with Bt-DUX (Bt=bone tumor)

Conditions

Sarcoma, Ewing; Osteosarcoma; Bone Tumor

Keywords

quality of life; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Bt-DUX scale

  The Bt-DUX scores reflect patients' personal impact: their individual values for cosmetic, social, emotional, and functional aspects of their life after surgery. The scoring of the items is done by abstract faces with varying expressions/smiley's, ranging from very happy (score 1) to sad (score 5). The raw item scores are converted into total and domain scores, ranging from 0 to 100, with the highest scores indicating better HRQoL (health related quality of life).

  quality of life will be measured once in a time interval ranging from 18 months to 5 years post surgery

Secondary Outcomes (1)

• TESS

  TESS will be administered once in a time interval ranging from 18 months to 5 years post surgery

Eligibility Criteria

• Age: 12 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with musculoskeletal tumor of the lower limbs who underwent salvage surgery at the "SC Clinica Ortopedica e Traumatologia III" of the Rizzoli Orthopedic Institute from January 2019 to June 2023 and will be followed up in the "SC Osteoncology, bone and soft tissues sarcomas and innovative therapies" of the same Institute for chemotherapy and physiotherapy treatment.

You may qualify if:

• Patients 12 years of age or older with musculoskeletal cancer undergoing lower extremity salvage surgery

You may not qualify if:

• patients undergoing amputation
• patients with difficulties in understanding the Italian language

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

Related Publications (21)

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• Bekkering WP, Vliet Vlieland TP, Koopman HM, Schaap GR, Beishuizen A, Anninga JK, Wolterbeek R, Nelissen RG, Taminiau AH. A prospective study on quality of life and functional outcome in children and adolescents after malignant bone tumor surgery. Pediatr Blood Cancer. 2012 Jun;58(6):978-85. doi: 10.1002/pbc.23328. Epub 2011 Oct 11.

  PMID: 21990185 BACKGROUND

• 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.

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• Ottaviani G, Robert RS, Huh WW, Jaffe N. Functional, psychosocial and professional outcomes in long-term survivors of lower-extremity osteosarcomas: amputation versus limb salvage. Cancer Treat Res. 2009;152:421-36. doi: 10.1007/978-1-4419-0284-9_23.

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• Robert RS, Ottaviani G, Huh WW, Palla S, Jaffe N. Psychosocial and functional outcomes in long-term survivors of osteosarcoma: a comparison of limb-salvage surgery and amputation. Pediatr Blood Cancer. 2010 Jul 1;54(7):990-9. doi: 10.1002/pbc.22419.

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• Bekkering WP, Vliet Vlieland TP, Koopman HM, Schaap GR, Schreuder HW, Beishuizen A, Tissing WJ, Hoogerbrugge PM, Anninga JK, Taminiau AH. Quality of life in young patients after bone tumor surgery around the knee joint and comparison with healthy controls. Pediatr Blood Cancer. 2010 May;54(5):738-45. doi: 10.1002/pbc.22439.

  PMID: 20127850 BACKGROUND

• Taylor MF, Pooley JA. Sarcoma survivors' perspectives on their body image and functional quality of life post-resection/limb salvage surgery. Eur J Cancer Care (Engl). 2017 Nov;26(6). doi: 10.1111/ecc.12667. Epub 2017 Feb 21.

  PMID: 28220660 BACKGROUND

• Bekkering WP, Billing L, Grimer RJ, Vlieland TP, Koopman HM, Nelissen RG, Taminiau AH. Translation and preliminary validation of the English version of the DUX questionnaire for lower extremity bone tumor patients (Bt-DUX): a disease-specific measure for quality of life. J Surg Oncol. 2013 Mar;107(4):353-9. doi: 10.1002/jso.23218. Epub 2012 Jul 17.

  PMID: 22806913 BACKGROUND

• Barrera M, Teall T, Barr R, Silva M, Greenberg M. Health related quality of life in adolescent and young adult survivors of lower extremity bone tumors. Pediatr Blood Cancer. 2012 Feb;58(2):265-73. doi: 10.1002/pbc.23017. Epub 2011 Feb 11.

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• Morri M, Bekkering PW, Cotti M, Meneghini M, Venturini E, Longhi A, Mariani E, Forni C. Cross-Cultural Validation of the Italian Version of the Bt-DUX: A Subjective Measure of Health-Related Quality of Life in Patients Who Underwent Surgery for Lower Extremity Malignant Bone Tumour. Cancers (Basel). 2020 Jul 23;12(8):2015. doi: 10.3390/cancers12082015.

  PMID: 32717924 BACKGROUND

• 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.

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• Dong S, Sun K, Xie L, Xu J, Sun X, Ren T, Huang Y, Yang R, Tang X, Yang F, Gu J, Guo W. Quality of life and Q-TWiST were not adversely affected in Ewing sarcoma patients treated with combined anlotinib, irinotecan, and vincristine: (Peking University People's Hospital Ewing sarcoma trial-02, PKUPH-EWS-02). Medicine (Baltimore). 2021 Dec 23;100(51):e28078. doi: 10.1097/MD.0000000000028078.

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• Solooki S, Mostafavizadeh Ardestani SM, Mahdaviazad H, Kardeh B. Function and quality of life among primary osteosarcoma survivors in Iran: amputation versus limb salvage. Musculoskelet Surg. 2018 Aug;102(2):147-151. doi: 10.1007/s12306-017-0511-y. Epub 2017 Oct 13.

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• Bishop MW, Advani SM, Villarroel M, Billups CA, Navid F, Rivera C, Quintana JA, Gattuso JS, Hinds PS, Daw NC. Health-Related Quality of Life and Survival Outcomes of Pediatric Patients With Nonmetastatic Osteosarcoma Treated in Countries With Different Resources. J Glob Oncol. 2018 Sep;4:1-11. doi: 10.1200/JGO.2016.005967. Epub 2017 Mar 24.

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• Weschenfelder W, Gast-Froehlich S, Spiegel C, Vogt M, Hofmann GO. Factors influencing quality of life, function, reintegration and participation after musculoskeletal tumour operations. BMC Cancer. 2020 Apr 25;20(1):351. doi: 10.1186/s12885-020-06837-x.

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MeSH Terms

Conditions

Sarcoma, Ewing; Osteosarcoma; Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases

Study Officials

• riccardo ruisi

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 16, 2023
• Study Start: February 14, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)