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临床试验/NCT06593561
NCT06593561已完成不适用

Turkish Version of Breast Edema Questionnare: Validity and Reliability Study

Aysima Barlak1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年10月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Breast Edema Questionnare

研究概览

简要总结

This study was planned to investigate the complaint of breast edema after breast conserving surgery and radiotherapy, which are considered as the main treatment modalities for breast cancer. The incidence of breast edema after these treatments ranges from 0% to 90.4%. In contrast to arm lymphedema, which has been described in detail in the literature, only a few studies have investigated breast edema. There is no survey study that comprehensively examines the presence of lymphedema and its clinical features (duration, severity, location). Studies to assess breast edema after breast cancer treatment have revealed the need for a condition-specific scale. Therefore, the "Breast Edema Questionnaire" was developed to assess breast edema in women who have undergone breast cancer surgery. The original language of this questionnaire is German and its reliability and validity has not been studied in another language. In this study, the validity and reliability of this questionnaire, which specifically assesses breast edema, will be tested in Turkish women.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Individuals with a diagnosis of breast cancer who have undergone breast-conserving surgery
  • individuals who have signed the Informed Consent form

排除标准

  • illiterate individuals

结局指标

主要结局

Breast Edema Questionnare

时间窗: one week

Unlike arm lymphedema, which is described in detail in the literature, there are only a few studies investigating breast lymphedema after breast cancer treatment. Breast ultrasound (US) is considered to be a more reliable and quantitative measure of breast edema. However, there is no survey study that comprehensively examines these outcome measures according to the presence and clinical features of lymphedema (duration, severity, location of lymphedema). In studies conducted to evaluate breast edema after breast cancer treatment, the necessity of a situation-specific scale has emerged. For this reason, the "Breast Edema Questionnaire" was developed to evaluate breast edema in women undergoing breast cancer surgery.

次要结局

  • Ultrasound(baseline)
  • Moisture Meter Compact(baseline)
  • Visual Analog Scale(baseline)

研究者

发起方
Aysima Barlak
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Aysima Barlak

PT

Hacettepe University

研究点 (1)

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