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临床试验/NCT01543711
NCT01543711已完成不适用

Long Term Follow-up of Persistent Pain, Sensory Disturbances and Lymphedema After Breast Cancer Treatment

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 2,411 人开始时间: 2012年1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
2,411
试验地点
1
主要终点
Prevalence of persistent pain

研究概览

简要总结

Persistent pain, sensory disturbances, lymphedema and functional impairment are frequently occurring late effects of breast cancer treatment. The investigators have previously published data on 3253 women treated for breast cancer in Denmark in the period 2005-2006. Very few studies have examined how these late effects change in time. The aim of this study is to examine in a well defined patient population any change in the prevalence of persistent pain, sensory disturbances, lymphedema and functional impairment, as well as risk factor profile.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosed with primary breast cancer between 2005-2006
  • Participated in a study in 2008

排除标准

  • Recurrent or new primary cancer
  • Metastatic cancer
  • Reconstructive surgery

结局指标

主要结局

Prevalence of persistent pain

时间窗: 6-7 years post operative

Prevalence of pain in the breast area, axilla, side of chest or arm, as a yes/no variable

Prevalence of patients changing pain status from the 2008 survey

时间窗: 6-7 years

次要结局

  • Prevalence of sensory disturbance(6-7 years)
  • Prevalence of self reported lymphedma(6-7 years)
  • Prevalence of functional impairment(6-7 years)
  • Risk factors associated for persistent pain, sensory disturbances, lymphedema or functional impairment(6-7 years)
  • Prevalence of patients changing status of sensory disturbances and self reported lymphedma(6-7 years)
  • Risk factors associated to changing status of sensory disturbances and lymphedema(6-7 years post operative)

研究者

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

Kenneth Geving Andersen

MD

Rigshospitalet, Denmark

研究点 (1)

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