Breast Cancer (Early Breast Cancer), Cancer Rehabilitation, Lymphedema Arm, Postoperative Shoulder Dysfunction
Conditions
Keywords
Prehabilitation, Breast Cancer Surgery, Shoulder Range of Motion, Upper Extremity Function, Cancer Rehabilitation, Exercise Therapy
Brief summary
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.
Detailed description
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.
Interventions
OTHERUsual Care
Usual Preoperative Care
OTHERHome-Based Prehabilitation Exercise Program
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.
Sponsors
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This is a single-center, prospective, two-arm, parallel-group randomized controlled trial. Participants will be randomized in a 1:1 ratio using a computer-generated block randomization scheme with variable block sizes. Randomization will be stratified by surgical type (mastectomy vs. breast-conserving surgery) and age group. The intervention group will receive a structured home-based prehabilitation program prior to surgery, while the control group will receive usual preoperative care. Outcome assessors will be blinded to group allocation. All analyses will be conducted according to the intention-to-treat principle.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Women aged 18-80 Stage I-III invasive breast cancer Scheduled for surgery ≥3 weeks before surgery No neoadjuvant therapy
Exclusion criteria
Exercise contraindication Active shoulder pathology Severe cardiopulmonary disease Planned neoadjuvant therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Shoulder Range of Motion (degrees) | Baseline to 12 weeks post-op | Measured by goniometer |
| DASH Score | Baseline to 12 weeks post-op | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grip Strength | Baseline to 12 weeks post-op | Grip Strength in kgs |
| Pain (Brief Pain Inventory - BPI) | baseline to 12 weeks | 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. |
| Fatigue (Functional Assessment of Cancer Therapy - Fatigue; FACT-F) | 0-12 months | 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. |
| Disability (World Health Organization Disability Assessment Schedule 2.0 - WHODAS 2.0) | baseline to 12 weeks | 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. |
| Anxiety and Depression (Hospital Anxiety and Depression Scale - HADS) | baseline to 12 weeks | 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. |
| Lymphedema Incidence | baseline to 2 years postop | 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). |
Countries
Turkey (Türkiye)
Contacts
CONTACTDemet Ferahman, MD
Outcome results
None listed