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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 主要终点
- Physiotherapy-related adverse events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.-
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Early Postoperative Rehabilitation Protocol (Procedure)
结局指标
主要结局
Physiotherapy-related adverse events
时间窗: From Day 1 after surgery up to 3 months after surgery
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.
Protocol completion rate
时间窗: At the end of the protocol, at three months after surgery
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.
Adherence to the home-based exercise program
时间窗: From Day 1 after surgery up to 3 months after surgery
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
次要结局
- Shoulder range of motion(Baseline, 1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery)
- Postoperative pain(1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery)
- Incidence of Axillary web syndrome(1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery)
- Persistence of axillary web syndrome at 3 months(3 months after surgery)
- Upper limb function(Baseline and 3 months after surgery)
- Shoulder strength(Baseline and 3 months after surgery)
- Overall functional capacity(Baseline and 3 months after surgery)
- Early detection of lymphedema(1 week, 10-15 days, 1 month, 2 months, and 3 months after surgery)
- Handgrip strength(Baseline and 3 months after surgery)
- Patient satisfaction(At 3 months after surgery)
研究者
Marta Aguilar-Rodriguez
Associate Professor, Department of Physiotherapy, Universitat de València, with clinical affiliation to Hospital Universitari i Politècnic La Fe.
Fundacion Para La Investigacion Hospital La Fe