跳至主要内容
临床试验/NCT03687749
NCT03687749已完成不适用

Presentation of First Time Attenders at Lymphedema Clinics: Cross-sectional Study

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 2 个国家目标入组 46 人开始时间: 2017年2月1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
46
试验地点
2
主要终点
Extracellular fluid in the arm

研究概览

简要总结

The first aim of this research project is to identify what factors motivate patients to seek assessment for early lymphedema and further, to gain insight into the signs and symptoms of developing lymphedema and the concurrent physical measurements.

The second aim is to identify other sensory signs and symptoms and changes in body perception which may be perceived by the patient as reflective of lymphedema, and to identify to which degree they contribute to the patients' motivation to seek referral to lymphedema clinics.

详细描述

One of the most challenging morbidities after breast cancer treatment is lymphedema. Approximately 20% of women treated for breast cancer with axillary lymph node dissection will be diagnosed with lymphedema. Pre- and post-operatively, women are informed about changes suggestive of lymphedema and guided about seeking further assessment. The investigators presume that if symptoms occur, patients will seek assessment. However, it is unknown whether this is true or if those prospectively monitored present earlier for treatment, or whether other factors specifically drive patients to seek further assessment. Understanding the early experience and presentation of secondary lymphedema will improve patient education and detection programs.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •women after breast cancer (> 18 years) with unilateral axillary lymph node dissection or sentinel node biopsy; mastectomy (with or without autologous reconstruction) or wide excision of the tumor
  • •able to give consent to participate in the research

排除标准

  • •patients under the age of 18 years

结局指标

主要结局

Extracellular fluid in the arm

时间窗: immediately after inclusion in the study

Bioimpedance spectroscopy (BIS) is a measurement tool used to determine the volume of extracellular fluid, of which lymph fluid is a component.

Arm volume

时间窗: immediately after inclusion in the study

Arm circumference measures are commonly used to diagnose and monitor lymphedema.

Pitting

时间窗: immediately after inclusion in the study

The pitting tests examines the responsiveness of tissue to pressure and can be used to help determine the stage of lymphedema.

次要结局

  • Temporal summation(immediately after inclusion in the study)
  • Self-reported signs and symptoms of lymphedema(immediately after inclusion in the study)
  • Impairments in function, activity limitations, and participation restrictions of patients with arm lymphedema(immediately after inclusion in the study)
  • Global Health Status/Quality of Life Score(immediately after inclusion in the study)
  • Body perception(immediately after inclusion in the study)
  • Pain intensity assessed with the Numeric Rating Scale(immediately after inclusion in the study)
  • Prevalence of neuropathic pain(immediately after inclusion in the study)
  • Tactile acuity (Two-point discrimination)(immediately after inclusion in the study)
  • Mechanical detection and pain threshold(immediately after inclusion in the study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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