This prospective, randomized, assessor-blinded, parallel-group clinical trial evaluates the effectiveness of a home-based upper extremity-focused prehabilitation program in women undergoing breast cancer surgery. Participants will be randomized 1:1 to either prehabilitation or usual care. Primary outcomes include shoulder range of motion and upper extremity function (DASH score). Secondary outcomes include grip strength, pain, fatigue, disability, anxiety/depression, and lymphedema incidence up to 2 years postoperatively.
Breast cancer surgery is associated with postoperative morbidity including shoulder dysfunction, pain, fatigue, and lymphedema. Prehabilitation aims to optimize functional capacity before surgery and may reduce postoperative complications. This single-center randomized controlled trial will enroll 54 women with stage I-III invasive breast cancer scheduled for mastectomy or breast-conserving surgery. Participants will be randomized to: 1. Home-based structured prehabilitation program 2. Usual preoperative care Primary endpoints are shoulder range of motion (goniometric measurement) and DASH score changes across multiple time points. Participants will be followed for up to 24 months for lymphedema development.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
54
Participants assigned to this arm will receive a structured, home-based prehabilitation program initiated at least three weeks prior to surgery. The intervention includes: (1) moderate-intensity aerobic exercise (3 sessions per week, 30 minutes per session, target intensity RPE 4-6/10), (2) upper extremity resistance exercises using elastic bands (3 sessions per week, 3 sets of 10 repetitions per exercise), and (3) mobility and stretching exercises focused on shoulder function. The program will be delivered through written materials and instructional exercise videos accessible via QR code. Participants will receive elastic resistance bands for training. Adherence and progression will be monitored weekly via remote follow-up (telephone or email contact). The intervention is non-pharmacological and designed to optimize upper extremity function prior to breast cancer surgery.
Usual Preoperative Care
Dr. Sadi Konuk Bakirkoy Training and Health Hospital
Istanbul, Istanbul, Turkey (Türkiye)
Change in Shoulder Range of Motion (degrees)
Measured by goniometer
Time frame: Baseline to 12 weeks post-op
DASH Score
Change in DASH Score The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire is a 30-item patient-reported outcome measure assessing upper extremity disability and symptoms. Scores range from 0 to 100, with higher scores indicating greater disability and worse functional status.
Time frame: Baseline to 12 weeks post-op
Grip Strength
Grip Strength in kgs
Time frame: Baseline to 12 weeks post-op
Pain (Brief Pain Inventory - BPI)
Pain severity and pain-related interference will be assessed using the Brief Pain Inventory (BPI). The BPI evaluates pain intensity (0-10 numeric rating scale) and its impact on daily functioning. Higher scores indicate greater pain severity and interference.
Time frame: baseline to 12 weeks
Fatigue (Functional Assessment of Cancer Therapy - Fatigue; FACT-F)
Cancer-related fatigue will be measured using the FACT-F questionnaire. The scale consists of 13 items scored from 0 to 4, with total scores ranging from 0 to 52. Lower scores indicate greater fatigue severity.
Time frame: 0-12 months
Disability (World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0)
Functional disability will be assessed using the 12-item interviewer-administered WHODAS 2.0. Total scores range from 0 to 48, with higher scores indicating greater disability and functional impairment.
Time frame: baseline to 12 weeks
Anxiety and Depression (Hospital Anxiety and Depression Scale - HADS)
Psychological distress will be measured using the Hospital Anxiety and Depression Scale (HADS), consisting of 14 items divided into anxiety (HADS-A) and depression (HADS-D) subscales. Each subscale ranges from 0 to 21, with higher scores indicating greater symptom severity.
Time frame: baseline to 12 weeks
Lymphedema Incidence
Upper extremity lymphedema will be assessed using circumferential limb measurements at standardized anatomical points. Lymphedema will be defined as a ≥2 cm inter-limb difference or ≥10% volume difference compared to the contralateral arm, confirmed by clinical evaluation. Outcome will be reported as incidence (yes/no).
Time frame: baseline to 2 years postop
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