跳至主要内容
临床试验/NCT07743294
NCT07743294招募中不适用

Effect of Preoperative Rehabilitation Exercise on Improving Postoperative Lymphedema, Quality of Life and Care Needs in Patients With Breast Cancer Surgery

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
105
试验地点
2
主要终点
Postoperative Upper Extremity Lymphedema Severity (Arm Circumference)

研究概览

简要总结

Breast cancer is one of the most common cancers among women worldwide, with surgery being a primary treatment. However, surgical tumor resection combined with lymph node dissection often leads to upper extremity lymphedema as a complication. This study aims to evaluate the effectiveness of preoperative rehabilitation exercise on upper limb function, lymphedema severity, quality of life, and post-discharge care needs in breast cancer patients undergoing surgery.

Participants will be assigned to either an experimental group receiving individualized preoperative rehabilitation exercise instruction or a control group receiving standard clinical nursing education. Outcomes will be measured across seven time points from pre-operation up to one year post-surgery.

详细描述

Background:

Surgical resection combined with axillary lymph node dissection in breast cancer patients frequently causes upper extremity lymphedema, negatively impacting physical function and quality of life. Implementing upper limb rehabilitation exercises prior to surgery may facilitate functional recovery and reduce postoperative complications.

Objectives:

  1. To evaluate the effect of preoperative upper limb rehabilitation exercise on reducing postoperative lymphedema in patients with breast cancer.
  2. To examine changes in quality of life and home care needs following preoperative rehabilitation intervention.
  3. To analyze factors influencing upper extremity function, lymphedema severity, quality of life, and care needs among breast cancer surgical patients.

Methods & Procedures:

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Diagnosed with malignant breast cancer confirmed by post-surgical tissue examination.
  • Receiving primary surgery, including tumor resection combined with axillary lymph node dissection.
  • Age 20 years or older.
  • Conscious, able to communicate in Mandarin or Taiwanese, aware of diagnosis, capable of completing questionnaires and participating in interventions, and signed informed consent.

排除标准

  • Severe cognitive impairment or unaware of diagnosis, unable to complete questionnaires or correctly execute intervention measures.
  • Patients in the control group who independently schedule outpatient rehabilitation after returning home.
  • Unable to communicate in Mandarin or Taiwanese.
  • Undergoing breast reconstruction surgery.

结局指标

主要结局

Postoperative Upper Extremity Lymphedema Severity (Arm Circumference)

时间窗: Baseline (1 day pre-operation), Postoperative Day 1, Week 2, Week 4, Month 3, Month 6, and Year 1

Measured by changes in upper extremity arm circumference (in centimeters) at standardized anatomical points to evaluate lymphedema severity.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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