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临床试验/NCT02627976
NCT02627976已完成不适用

The Effect of Wearing a Compression Vest on Patient Reported Pain, Quality of Life and Degree of Breast Edema.

UMC Utrecht0 个研究点目标入组 25 人开始时间: 2016年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
UMC Utrecht
入组人数
25
主要终点
Effect of wearing a compression vest on patient reported outcome pain

研究概览

简要总结

A common complication of breast conserving therapy is breast edema, which may lead to chronic pain, but also reduced quality of life (QoL) and poor cosmetic outcome. When pain is present most patients are currently treated with physical therapy, but evidence of its effectiveness is still low and a gold standard does not yet exist. A downside of physical therapy is that patients have to undergo the therapy regularly and treatment might even has to continue for years after symptoms and treatment started. Another treatment option is a compression vest with the potential, apart from reducing symptoms, to improve self-efficacy in patients because they decide when to wear it without the need to visit therapists. However effectiveness of the compression vest has not yet been objectified in studies.

The aim of this pilot study is to study if there is an effect on pain, QoL and the amount of breast edema of wearing a compression vest, in order to determine whether a large randomized study is feasible.

详细描述

In this pilot study, a maximum of 40 patients with symptomatic breast edema after surgery and/or radiotherapy for breast cancer are offered treatment with a compression vest. These patients will be followed for 6 months. Recruitment will continue until 20 active vest users are participating.

Primary endpoint is the course of patient reported pain over a 6 month period. Secondary endpoints are the course of degree of breast edema and quality of life over a 6 month period.

Patients who are wearing the vest may experience relief of breast edema related symptoms. In terms of burden, they might experience a tight feeling on the skin while wearing the vest, which could also be the case when treated with compression therapy and taping by a physical therapist. This tight feeling can be overcome by changing the vest to a larger size. All patients will fill out questionnaires upon inclusion, at 2 weeks, and 1, 3 and 6 months. This will take approximately 10-15 minutes per follow-up moment. Patients will have to visit the hospital at baseline and 1, 3 and 6 months after they started wearing the vest (i.e. 25 minute consult with physical examination, photo documentation of the breast and short basic follow-up questions), and it is expected that additional measurements for fitting a new compression vest will need to be taken 2-5 times during participation in the study. Those fitting measurements will be performed at a location as desired by the patient (e.g. UMC Utrecht or at patients' home).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Females, aged 18 years and older.
  • Patient treated with surgery and/or radiotherapy for breast cancer, with symptomatic breast edema (e.g. pain).
  • Visual Analog Scale (VAS) pain score of 3 or more.

排除标准

  • Inability to understand the Dutch language.
  • Indicated to undergo radiation treatment of the breast/chestwall within the next 6 months.
  • Cardiac complaints.
  • Pacemaker.
  • Port-a-cath.
  • Thrombosis of the arm.
  • Pulmonary embolism.
  • Pulmonary disease.
  • Pregnancy.
  • Non-breast cancer related lymph edema.
  • Clinical depression or anxiety disorder.

研究组 & 干预措施

breast edema vest

Active Comparator

干预措施: Compression vest, Thuasne (Device)

结局指标

主要结局

Effect of wearing a compression vest on patient reported outcome pain

时间窗: At baseline

Brief Pain Inventory (BPI) for pain questionnaire

Effect of wearing a compression vest on patient reported outcome pain six months after wearing a compression vest

时间窗: 6 months

Brief Pain Inventory (BPI) for pain questionnaire

Effect of wearing a compression vest on patient reported outcome pain one month after wearing a compression vest

时间窗: 1 month

Brief Pain Inventory (BPI) for pain questionnaire

Effect of wearing a compression vest on patient reported outcome pain two weeks after wearing a compression vest

时间窗: 2 weeks

Brief Pain Inventory (BPI) for pain questionnaire

Effect of wearing a compression vest on patient reported outcome pain three months after wearing a compression vest

时间窗: 3 months

Brief Pain Inventory (BPI) for pain questionnaire

次要结局

  • Effect of wearing a compression vest on degree of breast edema (CTCAE score)(At 6 months)
  • Effect of wearing a compression vest on patient reported quality of life(At 6 months after wearing a compression vest)

研究者

发起方
UMC Utrecht
申办方类型
Other
责任方
Principal Investigator
主要研究者

M.L. Gregorowitsch

MD, PhD student

UMC Utrecht

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Breast Edema Compression Vest | 临床试验