Safety, Feasibility, and Outcomes of Early Rehabilitation After Breast Cancer Surgery (EMOVE-BCS)
Evaluation of the Safety, Feasibility, and Functional Outcomes of a Structured Early Rehabilitation Protocol Following Breast Cancer Surgery: A Prospective Study in Routine Clinical Practice.
Breast cancer is one of the most common tumours in women. Advances in diagnosis and treatment have increased survival, but many women experience functional sequelae after breast and/or axillary surgery, including pain, reduced shoulder range of motion, loss of strength, difficulties in daily activities, axillary web syndrome, and possible lymphoedema. These impairments may affect autonomy, self-care, return to daily life, and correct arm positioning during adjuvant treatments such as radiotherapy.
Although therapeutic exercise and rehabilitation are recommended within oncology care, the implementation of early rehabilitation programmes after breast cancer surgery remains variable. This study aims to evaluate a structured, individualised, and supervised early rehabilitation protocol, EMOVE-BCS-LaFe, applied in routine clinical practice during the first three months after surgery.
The main hypothesis is that the protocol is safe and feasible, with a low frequency of physiotherapy-related adverse events requiring urgent care or programme suspension for more than 7 days, and high completion and adherence rates. Secondary outcomes include improvements in shoulder mobility, pain, upper limb function, strength, overall functional capacity, satisfaction, and differences according to type of breast and axillary surgery.
A prospective, single-centre, observational, single-arm cohort study will be conducted at HUIP La Fe. Adult women undergoing breast cancer surgery and referred to the programme will be consecutively included. The intervention includes preoperative education, therapeutic exercise initiated from the first postoperative day, home-based and supervised sessions, individualised progression, self-care recommendations, and early detection and management of axillary web syndrome and lymphoedema.
Follow-up will extend from preoperative assessment to three months after surgery. Safety, adherence, programme completion, range of motion, pain, upper limb function, shoulder strength, functional capacity, and satisfaction will be assessed using adverse event records, adherence data, goniometry, VAS, QuickDASH, dynamometry, 30-second Sit-to-Stand test, CSQ-8, and specific satisfaction items. Data analysis will be descriptive, estimating proportions, clinical-functional changes over time, and exploratory differences according to surgery type.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
Inclusion Criteria:
- Women aged ≥18 years undergoing breast cancer surgery at Hospital Universitari i Politècnic La Fe and referred to the early postoperative rehabilitation programme through the usual care pathway.
- Any type of breast surgery, including breast-conserving surgery and/or mastectomy, with or without reconstruction/prosthesis, and bilateral surgery.
- Any type of axillary surgery, including sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection (ALND).
- Patients undergoing surgery for recurrence and/or reoperation, for example margin widening, reoperation due to complications, or reoperation for oncological reasons, provided that it is clinically possible to start the programme.
- Ability to understand instructions, complete questionnaires, and sign the informed consent form.-
Exclusion Criteria:
- Inability to safely start the protocol during the first postoperative weeks due to medical or surgical contraindication, or due to severe clinical complications, for example the need for strict immobilization, specific restrictions, or prolonged hospital admission, according to the criteria of the surgical team or the rehabilitation service, preventing the protocol from being initiated according to the usual care schedule.
- Severe pre-existing upper limb condition, unilateral or bilateral, causing significant limitation of mobility or function before surgery and making the interpretation of clinical progression unreliable, for example shoulder arthroplasty, recent fracture, frozen shoulder in the inflammatory phase with severe limitation, or untreated massive rotator cuff tear with marked functional impairment.
- Severe neurological or musculoskeletal disease that significantly affects upper limb function and may influence the main outcome variables, for example stroke with major sequelae, spinal cord injury, or severe neuropathy.
- Cognitive impairment, severe decompensated psychiatric disorder, or language barrier without available support, preventing the participant from understanding instructions and completing assessments.
- Participation in another study that may substantially interfere with the results, according to the investigator's judgment.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Megelőzés
- Kiosztás: N/A
- Beavatkozó modell: Egyetlen csoportos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: Early rehabilitation protocol
Participants assigned to this single study arm will receive the structured EMOVE-BCS-LaFe early postoperative rehabilitation protocol after breast cancer surgery.
The protocol includes preoperative education, therapeutic exercise initiated from the first postoperative day, individualized phase-based progression, self-care recommendations, monitoring of physiotherapy-related adverse events, adherence recording, and early detection and management of axillary web syndrome and lymphedema during the three-month postoperative follow-up.
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A structured, individualized, phase-based early postoperative rehabilitation protocol after breast cancer surgery.
The intervention includes preoperative education, therapeutic exercise initiated from the first postoperative day, home-based exercise with adherence monitoring, supervised progression according to breast and axillary surgery type, self-care recommendations, and early detection and management of axillary web syndrome and lymphedema.
The protocol is delivered as part of routine clinical practice and followed for three months after surgery.
Más nevek:
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Physiotherapy-related adverse events
Időkeret: From Day 1 after surgery up to 3 months after surgery
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Percentage of participants with at least one physiotherapy-related adverse event requiring urgent medical care and/or suspension of the rehabilitation protocol for more than 7 days.
Adverse events will be prospectively recorded at each postoperative visit and through review of the medical record.
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From Day 1 after surgery up to 3 months after surgery
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Protocol completion rate
Időkeret: At the end of the protocol, at three months after surgery
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Percentage of participants who complete the 3-month follow-up assessment and the early postoperative rehabilitation protocol.
Reasons for non-completion will also be recorded.
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At the end of the protocol, at three months after surgery
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Adherence to the home-based exercise program
Időkeret: From Day 1 after surgery up to 3 months after surgery
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Percentage of participants who adhere to the home-based exercise program, defined as performing the prescribed exercises at least 4 days per week.
Adherence will also be recorded as the mean number of exercise days per week
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From Day 1 after surgery up to 3 months after surgery
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Shoulder range of motion
Időkeret: Baseline, 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
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Active shoulder flexion, abduction and rotation range of motion will be measured in degrees using standardized goniometry.
Changes from baseline to the final 3-month assessment will be described.
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Baseline, 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
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Postoperative pain
Időkeret: 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
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Postoperative pain intensity will be assessed using a 0-10 visual analogue scale (VAS) where higher scores indicate greater pain.
Changes in pain intensity will be assessed during postoperative follow-up.
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1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
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Incidence of Axillary web syndrome
Időkeret: 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
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Percentage of participants who develop axillary web syndrome during postoperative follow-up, assessed by clinical examination based on the presence or absence of visible or palpable axillary cords.
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1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
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Persistence of axillary web syndrome at 3 months
Időkeret: 3 months after surgery
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Percentage of participants with axillary web syndrome still present at the final follow-up visit, assessed by clinical examination based on the presence or absence of visible or palpable axillary cords.
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3 months after surgery
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Upper limb function
Időkeret: Baseline and 3 months after surgery
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Upper limb function will be assessed using the Spanish version of the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire.
Scores range from 0 to 100, with higher scores indicating greater disability and worse upper limb function.
Changes from baseline to the 3-month assessment will be evaluated.
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Baseline and 3 months after surgery
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Shoulder strength
Időkeret: Baseline and 3 months after surgery
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Shoulder strength will be assessed in kilograms using a handheld dynamometer according to a standardized protocol.
The mean value of three attempts will be recorded.
Changes from baseline to the 3-month assessment will be evaluated.
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Baseline and 3 months after surgery
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Overall functional capacity
Időkeret: Baseline and 3 months after surgery
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Overall functional capacity will be assessed using the 30-second Sit-to-Stand test.
Changes in the number of repetitions from baseline to the final assessment will be described.
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Baseline and 3 months after surgery
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Early detection of lymphedema
Időkeret: 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
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Percentage of participants with suspected lymphedema during postoperative follow-up.
Suspected lymphedema will be recorded as present or absent based on clinical assessment and comparison between upper limbs according to routine clinical practice.
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1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery
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Handgrip strength
Időkeret: Baseline and 3 months after surgery
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Handgrip strength will be assessed using a hand dynamometer according to a standardized protocol.
Changes from baseline to the final 3-month assessment will be described.
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Baseline and 3 months after surgery
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Patient satisfaction
Időkeret: At 3 months after surgery
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Patient satisfaction with physiotherapy care will be assessed using the Spanish version of the Client Satisfaction Questionnaire-8 (CSQ-8).
Total scores range from 8 to 32, with higher scores indicating greater satisfaction.
Additional protocol-specific satisfaction items will be reported descriptively.
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At 3 months after surgery
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Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
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