An interventional study of Preoperative Upper Limb Rehabilitation Exercise and Standard Nursing Care and Education in Breast Cancer and Rehabilitation, sponsored by National Taiwan University Hospital. Recruiting at 2 sites in Taiwan. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Supportive care
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.
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:
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.
Data Collection Timeline:
Data will be collected at seven time points:
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 105 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group receive individualized instruction and guidance on upper limb rehabilitation exercises starting 1 day prior to surgery.
Behavioral: Preoperative Upper Limb Rehabilitation Exercise
Participants in this group receive routine clinical nursing education preoperatively or on postoperative Day 1 according to standard ward procedures.
Other: Standard Nursing Care and Education
Individualized instruction and guidance on upper limb rehabilitation exercises starting 1 day prior to surgery to reduce postoperative lymphedema and improve physical function.
Routine clinical nursing education executed preoperatively or on postoperative Day 1 according to standard ward procedures.
Postoperative Upper Extremity Lymphedema Severity (Arm Circumference)
Measured by changes in upper extremity arm circumference (in centimeters) at standardized anatomical points to evaluate lymphedema severity.
Time frame: Baseline (1 day pre-operation), Postoperative Day 1, Week 2, Week 4, Month 3, Month 6, and Year 1
Plan to share: No — Individual participant data will not be shared to protect participant privacy and maintain data confidentiality in accordance with institutional review board (IRB) guidelines and informed consent agreements.
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for Dec 2026, 30 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 30 months is close to that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
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