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

Osteosarcoma Clinical Trial

— Onco-QoL  

Official title:

Quality of Life of Patients With Bone Tumors of the Lower Limbs Treated With Salvage Surgery: a Long-term Follow-up Study.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05772312
• Other study ID #: 5000
• Status: Enrolling by invitation
• Start date: January 17, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Description:

Musculoskeletal cancers are extremely rare, accounting for approximately 0.2% of all cancers, 14% are bone sarcomas, which occur more frequently in children and adolescents. The most frequent location is at the metaphyseal level of the femur (42%) and tibia (19%).

Surgery and chemotherapy treatments have significantly increased survival rates for patients with bone tumor. Early rehabilitation of these patients after surgery is to promote recovery as early as possible with maximum autonomy. In literature, data about the association between the early functional recovery and quality of life are few. Long-term studies about the quality of life of these patients are so necessary. The quality of life is measured with several scale that included a set of non-specific domains for bone tumor patients. For this reason, a specific assessment scale was introduced and validated in 2013 to measure the quality of life of patients with bone cancer of the lower limbs, the Bt-DUX scale.

In 2019 the Bt-DUX scale was validated in Italian.

Considering the rarity of the disease, and verified that the number of patients treated in 2019 and 2020, is 30 and 32, respectively, the investigators estimate to enroll from January 2019 to June 2023 a number of patients equal to 100, considering a rejection rate of 10%.

Patient characteristics and scale values will be summarized using descriptive statistics (absolute frequencies and percentages for categorical variables, mean and standard deviation or median and interquartile range for continuous variables).

The variables collected will be: age, sex, diagnosis, type of surgery, site of tumour, complication (infection, relapses, metastasis), TESS (Toronto Extremity Salvage Score) (at 3 and 6 months), knee or hip flexion (at 3 and 6 months), quadriceps or hip abductor strength (at 3 and 6 months) and time up and go (at 3 and 6 months).

The relationship of patient characteristics with functional outcomes and quality of life will be investigated using multiple regression models, while the correlation between measures of functional recovery will be analyzed using Pearson's or Spearman's correlation coefficient, depending on the distribution of the variables considered.

The aim of the study is to describe the quality of life of patients undergoing salvage surgery of the lower limb for musculoskeletal tumors with a long follow-up and to investigate the association with early functional recovery.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Neoplasms
• Bone Tumor
• Neuroectodermal Tumors, Primitive, Peripheral
• Osteosarcoma
• Sarcoma, Ewing

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (21)

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. — View Citation

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. — View Citation

Bekkering WP, van Egmond-van Dam JC, Bramer JAM, Beishuizen A, Fiocco M, Dijkstra PDS. Quality of life after bone sarcoma surgery around the knee: A long-term follow-up study. Eur J Cancer Care (Engl). 2017 Jul;26(4). doi: 10.1111/ecc.12603. Epub 2016 Nov 7. — View Citation

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. — View Citation

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. — View Citation

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. — 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. ESMO Open. 2020 Oct;5(5):e000914. doi: 10.1136/esmoopen-2020-000914. — View Citation

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. — View Citation

Eiser C. Assessment of health-related quality of life after bone cancer in young people: easier said than done. Eur J Cancer. 2009 Jul;45(10):1744-7. doi: 10.1016/j.ejca.2009.02.025. Epub 2009 Mar 25. — View Citation

Heyberger 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. — View Citation

Kim 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. — View Citation

Liu Y, Hu A, Zhang M, Shi C, Zhang X, Zhang J. Correlation between functional status and quality of life after surgery in patients with primary malignant bone tumor of the lower extremities. Orthop Nurs. 2014 May-Jun;33(3):163-70. doi: 10.1097/NOR.0000000000000050. — View Citation

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. — View Citation

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. — View Citation

Punzalan 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. — View Citation

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. — 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 Surg Oncol. 2020 Mar;121(4):630-637. doi: 10.1002/jso.25849. Epub 2020 Jan 19. — View Citation

Sadykova 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	TESS	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."	TESS will be administered once in a time interval ranging from 18 months to 5 years post surgery