Clinical trial · Observational
Quality of Life of Patients With Bone Tumor of the Lower Limbs Treated With Salvage Surgery
Quality of Life of Patients With Bone Tumors of the Lower Limbs Treated With Salvage Surgery: a Long-term Follow-up Study.
NCT05772312CI-TRIAL-00087700Onco-QoLcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Tumor | Bone Neoplasm | ALIAS | 0.90 |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoma, Ewing | Ewing Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Bt-DUX scale
- timeFrame
- quality of life will be measured once in a time interval ranging from 18 months to 5 years post surgery
- description
- 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).
Secondary outcomes (1)
- measure
- TESS
- timeFrame
- TESS will be administered once in a time interval ranging from 18 months to 5 years post surgery
- description
- The TESS is a self-administered questionnaire evaluating possible limitations in physical activity. A total of 30 questions are included in the TESS, and the degree of disability is rated from 0 (complete disability) to 5 (no functional impairment) in each item. Similar to MSTS (musculoskeletal tumour society score) for lower extremity, the final TESS score is converted to a score ranging from 0 to 100 points. If a question in TESS score does not apply to the patient, the last can respond "not applicable."
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Patients 12 years of age or older with musculoskeletal cancer undergoing lower extremity salvage surgery Exclusion Criteria: * patients undergoing amputation * patients with difficulties in understanding the Italian language
References
Publications (21)
- BACKGROUNDHeyberger C, Auberger G, Babinet A, Anract P, Biau DJ. Patients with Revision Modern Megaprostheses of the Distal Femur Have Improved Disease-Specific and Health-Related Outcomes Compared to Those with Primary Replacements. J Knee Surg. 2018 Oct;31(9):822-826. doi: 10.1055/s-0037-1615298. Epub 2017 Dec 21. PMID 29270950
- BACKGROUNDSadykova LR, Ntekim AI, Muyangwa-Semenova M, Rutland CS, Jeyapalan JN, Blatt N, Rizvanov AA. Epidemiology and Risk Factors of Osteosarcoma. Cancer Invest. 2020 May;38(5):259-269. doi: 10.1080/07357907.2020.1768401. Epub 2020 Jun 1. PMID 32400205
- BACKGROUNDPunzalan M, Hyden G. The role of physical therapy and occupational therapy in the rehabilitation of pediatric and adolescent patients with osteosarcoma. Cancer Treat Res. 2009;152:367-84. doi: 10.1007/978-1-4419-0284-9_20. PMID 20213402
- BACKGROUNDKim TWB, Kumar RJ, Gilrain KL, Kubat E, Devlin C, Honeywell S, Amin SJ, Gutowski CJ. Team Approach: Rehabilitation Strategies for Patients After Osteosarcoma Reconstructive Surgery. JBJS Rev. 2020 Oct;8(10):e19.00225. doi: 10.2106/JBJS.RVW.19.00225. PMID 33044254
- BACKGROUNDBekkering 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
- BACKGROUNDden 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
- 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.