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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation Group | Experimental | Participants will receive a structured home-based prehabilitation program delivered through written materials and instructional exercise videos (QR code access). The program includes: Aerobic training (3/week, 30-40 minutes, RPE 4-6) Upper extremity resistance exercises (3 days/week, 3 sets of 10 repetitions) Mobility and stretching exercises Adherence will be monitored through weekly remote follow-up (telephone) |
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| Usual Care | Active Comparator | Standard preoperative counseling without structured exercise prescription. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-Based Prehabilitation Exercise Program | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Shoulder Range of Motion (degrees) | Measured by goniometer | 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. | Baseline to 12 weeks post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Grip Strength | Grip Strength in kgs | 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. |
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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
This study is limited to female participants because breast cancer surgery in this protocol focuses on women with stage I-III invasive breast cancer. Although breast cancer can occur in men, male patients represent a small proportion of cases and may have different clinical and surgical characteristics. Restricting enrollment to women ensures a more homogeneous study population and improves internal validity.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Demet Ferahman, MD | Contact | +905364702930 | demetferahman@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Sadi Konuk Bakirkoy Training and Health Hospital | Istanbul | Istanbul | 34140 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33072603 | Background | Brahmbhatt P, Sabiston CM, Lopez C, Chang E, Goodman J, Jones J, McCready D, Randall I, Rotstein S, Santa Mina D. Feasibility of Prehabilitation Prior to Breast Cancer Surgery: A Mixed-Methods Study. Front Oncol. 2020 Sep 25;10:571091. doi: 10.3389/fonc.2020.571091. eCollection 2020. |
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Individual participant data will not be shared due to institutional data protection policies and local regulations governing patient privacy. De-identified data may be available upon reasonable request and subject to ethics committee approval.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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.
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| Usual Care | Other | Usual Preoperative Care |
|
| 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. | 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. | 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. | 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). | baseline to 2 years postop |
| D017437 |
| Skin and Connective Tissue Diseases |