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NCT Number: NCT07743294

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

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.

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Key information

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital, Taipei, Taiwan

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About this study

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:

  • To evaluate the effect of preoperative upper limb rehabilitation exercise on reducing postoperative lymphedema in patients with breast cancer.
  • To examine changes in quality of life and home care needs following preoperative rehabilitation intervention.
  • 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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Preoperative Upper Limb Rehabilitation Exercise

Behavioral

Individualized instruction and guidance on upper limb rehabilitation exercises starting 1 day prior to surgery to reduce postoperative lymphedema and improve physical function.

Standard Nursing Care and Education

Other

Routine clinical nursing education executed preoperatively or on postoperative Day 1 according to standard ward procedures.

Primary outcomes

  1. Postoperative Upper Extremity Lymphedema Severity (Arm Circumference)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Meng-Ping Hsiao

CONTACT

[email protected]

+886-919865349

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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