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

Обзор

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.

Подробное описание

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:

This longitudinal quasi-experimental study will recruit 105 patients scheduled for tumor resection with axillary lymph node dissection at National Taiwan University Hospital and National Taiwan University Hospital Cancer Center.

* Experimental Group: Receives individualized preoperative instruction and guidance on upper limb rehabilitation exercises starting preoperatively. * Control Group: Receives routine clinical nursing education preoperatively or on postoperative Day 1 according to standard ward procedures.

Data Collection Timeline:

Data will be collected at seven time points:

1. Pre-operation (1 week / 1 day prior to surgery) 2. Postoperative Day 1 3. Postoperative Week 2 (first clinic visit) 4. Postoperative Week 4 5. Postoperative Month 3 6. Postoperative Month 6 7. Postoperative Year 1

Assessment Parameters:

Measurements include arm circumference, handgrip strength, shoulder range of motion, functional activities of daily living (ADL), lymphedema-related symptoms, quality of life, and care needs. Descriptive statistics and Generalized Estimating Equations (GEE) will be used to analyze treatment outcomes over time.

Вмешательства

• Поведенческое Preoperative Upper Limb Rehabilitation Exercise
  Individualized instruction and guidance on upper limb rehabilitation exercises starting 1 day prior to surgery to reduce postoperative lymphedema and improve physical function.
• Другое Standard Nursing Care and Education
  Routine clinical nursing education executed preoperatively or on postoperative Day 1 according to standard ward procedures.

Первичные конечные точки

• Postoperative Upper Extremity Lymphedema Severity (Arm Circumference) [Срок оценки: Baseline (1 day pre-operation), Postoperative Day 1, Week 2, Week 4, Month 3, Month 6, and Year 1]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Тайвань · 2 центра

• National Taiwan University Hospital Cancer Center — Taipei
• National Taiwan University Hospital — Taipei

Идентификаторы

NCT: NCT07743294 · 202405003RINB · NTUCCS-113-38

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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