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Sarcoma, EwingOnco-QoLNCT05772312

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

An observational study of Sarcoma, Ewing and Osteosarcoma, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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) Read more about this study

Who is it for?
Ages 12 to 90 years
Conditions the study is for
Sarcoma, Ewing, Osteosarcoma, Bone Tumor
How many people
41 participants
Where
1 siteItaly
Study dates
14 Feb 2023to 31 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 90 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Istituto Ortopedico Rizzoli

    Bologna, 40136

Other trials in Italy

About this study

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

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)

Read the detailed 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.

Keywords
quality of life, rehabilitation
Medical subject headings
Sarcoma, Ewing, Osteosarcoma, Bone Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (1)

  1. 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."

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2023
  2. Study start14 Feb 2023
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05772312
Sponsor's protocol ID
5000
Acronym
Onco-QoL
Status last verified
Mar 2025
First submitted
6 Mar 2023
Last updated
26 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29270950

  • 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.

    PubMed 32400205

  • 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.

    PubMed 20213402

  • 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.

    PubMed 33044254

  • 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.

    PubMed 21990185

  • 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.

    PubMed 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.

    PubMed 20213405

  • 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.

    PubMed 20135700

  • 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.

    PubMed 28657211

  • 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.

    PubMed 19327986

  • 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.

    PubMed 20127850

  • 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.

    PubMed 28220660

  • 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.

    PubMed 22806913

  • 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.

    PubMed 21319288

  • 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.

    PubMed 24845842

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcoma, Ewing and Osteosarcoma, run by Istituto Ortopedico Rizzoli at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bt-DUX scale (time frame: quality of life will be measured once in a time interval ranging from 18 months to 5 years post surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05772312, which also lists 21 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.

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