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Onco-QoL: Quality of Life of Patients With Bone Tumor of the Lower Limbs Treated With Salvage Surgery

Sponsor
Istituto Ortopedico Rizzoli (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05772312
Collaborator
(none)
100
Enrollment
1
Location
23.5
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Quality of Life of Patients With Bone Tumors of the Lower Limbs Treated With Salvage Surgery: a Long-term Follow-up Study.
    Actual Study Start Date :
    Jan 17, 2023
    Anticipated Primary Completion Date :
    Dec 31, 2024
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Bt-DUX scale [quality of life will be measured once in a time interval ranging from 18 months to 5 years post surgery]

      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 Outcome Measures

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

      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 Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istituto Ortopedico Rizzoli Bologna Italy 40136

    Sponsors and Collaborators

    • Istituto Ortopedico Rizzoli

    Investigators

    • Principal Investigator: riccardo ruisi, Istituto Ortopedico Rizzoli

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Riccardo Ruisi, principal investigator, Istituto Ortopedico Rizzoli
    ClinicalTrials.gov Identifier:
    NCT05772312
    Other Study ID Numbers:
    • 5000
    First Posted:
    Mar 16, 2023
    Last Update Posted:
    Mar 21, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Riccardo Ruisi, principal investigator, Istituto Ortopedico Rizzoli
    quality of life
    rehabilitation
    Additional relevant MeSH terms:
    Osteosarcoma
    Bone Neoplasms
    Sarcoma, Ewing
    Neuroectodermal Tumors, Primitive, Peripheral

    Study Results

    No Results Posted as of Mar 21, 2023