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临床试验/NCT02536053
NCT02536053已完成不适用

Functional Outcomes and Health Related Quality of Life in Lower Extremity Soft Tissue Sarcoma Patients After Limb Salvage: A Prospective Study

Helsinki University Central Hospital1 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
141
试验地点
1
主要终点
Validity of the lower-limb Musculoskeletal Tumor Society score and the Toronto Extremity Salvage Score

研究概览

简要总结

This study aims to:

  1. validate the Finnish version of the Musculoskeletal Tumor Society scale and the Toronto Extremity Salvage Score lower extremity sections and to
  2. assess the functional ability and health-related quality of life (HRQoL) of lower extremity sarcoma patients who have undergone limb salvage surgery.

详细描述

The first purpose of this study is to validate the Finnish version of the Musculoskeletal Tumor Society scale and the Toronto Extremity Salvage Score upper extremity sections. The second purpose is to chart the functional capabilities and health-related quality of life (HRQoL) of upper extremity sarcoma patients who have undergone limb salvage surgery with local or free flaps.

Patient hospital records are retrospectively reviewed to chart the demographic and clinical data.

The recruitment of patient takes place at the outpatient clinic of Department of Oncology, Helsinki University Hospital. The study includes a cross-sectional assessment at one year follow-up with five validated questionnaires. A follow-up is conducted three years after surgery in the outpatient clinic.

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

入选标准

  • Lower extremity soft tissue sarcoma locating in between hip/gluteus to foot
  • No metastasis at the time of diagnosis
  • Undergone limb salvage surgery
  • A minimum of 1 year follow-up
  • Written consent
  • Age > 18

排除标准

  • No limb-salvage surgery due to sarcoma

结局指标

主要结局

Validity of the lower-limb Musculoskeletal Tumor Society score and the Toronto Extremity Salvage Score

时间窗: two to five years

The validity is studied

Reliability of the lower-limb Musculoskeletal Tumor Society score and the Toronto Extremity Salvage Score

时间窗: two to five years

The test-retest reliability is studied

Health-related quality of life after limb salvage

时间窗: two to five years

Assessment of health-related quality of life

Assessment of the functional ability after limb salvage

时间窗: two to five years

Assessment of functional ability

次要结局

  • Quality of Life Questionnaire-Core 30(two to five years)
  • The 15-dimensions health-related quality of life instrument(two to five years)
  • The Musculoskeletal Tumor Society score lower extremity section(two to five years)
  • The Toronto Extremity Salvage Score lower extremity section(two to five years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jussi Repo

MD

Helsinki University Central Hospital

研究点 (1)

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