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临床试验/NCT05772312
NCT05772312已完成不适用

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

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2023年2月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
1
主要终点
Bt-DUX scale

研究概览

简要总结

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)

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
12 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Bt-DUX scale

时间窗: 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).

次要结局

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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