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Clinical Trials/NCT07743294
NCT07743294RecruitingNot Applicable

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 sites in 1 country105 target enrollmentStarted: June 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
105
Locations
2
Primary Endpoint
Postoperative Upper Extremity Lymphedema Severity (Arm Circumference)

Study Overview

Brief Summary

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.

Detailed Description

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:

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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