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临床试验/NCT04104750
NCT04104750已完成不适用

The Assessment of Fatigue and Quality of Life in Patients With Bone Tumor, Undergoing Chemotherapy Treatment and Possible Predictive Factors

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 155 人开始时间: 2019年7月26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
155
试验地点
1
主要终点
the patient's Fatigue

研究概览

简要总结

The aim of the present observational study is to evaluate and describe the evolution over time of the fatigue and the quality of life of patients with bone tumor, in Rizzoli Orthopedic Institute, Chemotherapy ward, during the chemotherapy treatment and in the first phase of follow-up and to identify possible prognostic factors. Such knowledge is a necessary precondition for identifying patients and the periods most at risk due to the onset of fatigue, so as to be able to hypothesize adequate containment strategies.

详细描述

Fatigue syndrome It is a clinical condition, linked to the oncological pathology, extremely widespread and in patients undergoing chemotherapy and / or radiotherapy it is common in 80% of patients. Literature stress the need for systematic studies in cancer populations with different types of cancer and at different stages of the disease using patient-oriented fatigue assessment tools. The Brief Fatigue Inventory (BFI) is one of the scales used precisely in the evaluation of this syndrome and has proved to be a reliable and easy to use tool, also validated in Italian. Several authors have also shown that reduced physical activity and a worse quality of life are associated with fatigue, particularly in young patients.Several authors describe the experience of 11 new sarcoma patients undergoing chemotherapy treatment. Fatigue had been described as the prevalent symptom and was related to a worse quality of life.

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 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients diagnosed with bone tumors who start a new chemotherapy treatment protocol

排除标准

  • patients with little knowledge of the Italian language

结局指标

主要结局

the patient's Fatigue

时间窗: through study completion, an average of 5years

will be measured during the treatment period with antiblastic drugs and part of the followup period. To this end the Brief Fatigue Inventory scale validated in Italian will be used which includes 9 items with a score for each of 0 to 10 and a consequent total score from 0 to 90.

次要结局

  • the quality of life of patients(through study completion, an average of 5years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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