Safety, Feasibility, and Outcomes of Early Rehabilitation After Breast Cancer Surgery

Official title

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.

Overview

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.

Interventions

• Procedure Early Postoperative Rehabilitation Protocol
  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 clini

Primary outcome measures

• Physiotherapy-related adverse events [Time frame: From Day 1 after surgery up to 3 months after surgery]
• Protocol completion rate [Time frame: At the end of the protocol, at three months after surgery]
• Adherence to the home-based exercise program [Time frame: From Day 1 after surgery up to 3 months after surgery]

Secondary outcome measures (10)

• Shoulder range of motion [Time frame: Baseline, 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery]
• Postoperative pain [Time frame: 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery]
• Incidence of Axillary web syndrome [Time frame: 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery]
• Persistence of axillary web syndrome at 3 months [Time frame: 3 months after surgery]
• Upper limb function [Time frame: Baseline and 3 months after surgery]
• Shoulder strength [Time frame: Baseline and 3 months after surgery]
• Overall functional capacity [Time frame: Baseline and 3 months after surgery]
• Early detection of lymphedema [Time frame: 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery]
• Handgrip strength [Time frame: Baseline and 3 months after surgery]
• Patient satisfaction [Time frame: At 3 months after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07651696 · 26.04.2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗