Effects of a Telerehabilitation Intervention in the Management of Complications After Breast Cancer Surgery: Randomized Controlled Trial
概览
- 阶段
- 不适用
- 干预措施
- Telerehabilitation
- 疾病 / 适应症
- Breast Neoplasms
- 发起方
- Fondazione Policlinico Universitario Campus Bio-Medico
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- Complications
- 状态
- 招募中
- 最后更新
- 11天前
概览
简要总结
The most common complaints after breast surgery are postoperative pain reported in up to 68% of patients, musculoskeletal problems in the shoulder and functional limitations in up to 59% of patients after mastectomy and quadrantectomy, reduction in range of motion ( ROM) in 24-53% and strength deficit.
The study aims to verify the effectiveness of a telerehabilitation treatment in terms of prevention of possible complications following breast cancer surgery.
Primary objective: to examine whether the group of patients undergoing rehabilitation surgery in the immediate post-operative period shows a reduction in the onset of complications compared to the group of patients who followed standard procedures.
Secondary objective: to study any preoperative prognostic factors for the onset of complications, to study the effectiveness of the rehabilitation treatment in terms of reduction of painful symptoms, improvement of joint ROM, muscle strength and perceived quality of life.
详细描述
Breast cancer is the most common malignancy in women worldwide. Advances in early detection and improved treatment of breast cancer have led to increased survival after diagnosis, resulting in many more women living with the consequences of cancer treatment. Breast cancer surgeries and treatments can cause arm morbidity that can progress beyond 2.5 years. The most common complaints after breast surgery are postoperative pain reported in up to 68% of patients, musculoskeletal problems in the shoulder and functional limitations in up to 59% of patients after mastectomy and quadrantectomy, reduction in range of motion ( ROM) in 24-53% and strength deficit. Other complications include postoperative axillary web syndrome (AWS), which can cause pain and movement limitations; lymphedema reported with a prevalence of 6-52% especially after axillary lymph node dissection (ALND); kinematic alterations that may promote future development of rotator cuff disease; scapulohumeral dyskinesia, proprioception deficit, postural alterations and reduced quality of life. There is scientific evidence in the literature to suggest that early postoperative exercise is safe and can improve shoulder function; however, uncertainty remains about the optimal content, timing, and cost-effectiveness of exercise interventions. The study aims to verify the effectiveness of a rehabilitation treatment in terms of prevention of possible complications following breast cancer surgery. Primary objective: to examine whether the group of patients undergoing rehabilitation surgery in the immediate post-operative period shows a reduction in the onset of complications compared to the group of patients who followed standard procedures. Secondary objective: to study any preoperative prognostic factors for the onset of complications, to study the effectiveness of the rehabilitation treatment in terms of reduction of painful symptoms, improvement of joint ROM, muscle strength and perceived quality of life.
研究者
入排标准
入选标准
- •diagnosis of breast cancer
- •Having undergone quadrantectomy or mastectomy surgery
- •Age \> 18 years
- •Signature of informed consent
排除标准
- •Neurological deficits with sensorimotor impairment of the upper limb
- •Cognitive deficits that prevent the completion of questionnaires (MMSE\>24)
研究组 & 干预措施
Telerehabilitation
In the days following surgery, intervention group will receive a structured rehabilitation session by a physiotherapist. In this session, two booklets will be provided to the patients, with the aim of informing and educating, regarding the most frequent complications after breast cancer surgery and how to avoid their possible onset through the demonstration of exercises to be carried out at home, self-massage techniques of the scar, behaviors and lifestyle to be adopted immediately after surgery. This group will carry out, starting from 10 days post-surgery, a home tele-rehabilitation intervention from Monday to Friday via the TeleHab device (Vald Performance) until 2 months after surgery. Exercises for ROM recovery and strength recovery will be carried out three days a week and only exercises for ROM recovery will be carried out two days a week.
干预措施: Telerehabilitation
Standard care
Standard care consists of the usual treatment according to current clinical practice, no structured physiotherapeutic interventions will be carried out which generally consists of the delivery of two booklets, with the aim of informing and educating, regarding the most frequent complications after breast cancer surgery and how to avoid its possible onset through the demonstration of exercises to be carried out at home, self-massage techniques for the scar, behaviors and lifestyle to be adopted immediately after surgery.
干预措施: Standard Care
结局指标
主要结局
Complications
时间窗: 6 months after surgery
Number of complications (i.e. axyllary web syndrome; lymphedema)
Complications
时间窗: 7-10 days after surgery
Number of complications (i.e. axyllary web syndrome; lymphedema; persistent pain)
Complications
时间窗: 2 months after surgery
Number of complications (i.e. axyllary web syndrome; lymphedema)
次要结局
- Upper limb pain(6 months after surgery)
- Upper limb pain(before surgery)
- Upper limb pain(7-10 days after surgery)
- Upper limb pain(2 months after surgery)
- Neck Disability(before surgery)
- Neck Disability(7-10 days after surgery)
- Neck Disability(2 months after surgery)
- Upperlimb Disability(before surgery)
- Upperlimb Disability(7-10 days after surgery)
- Upperlimb Disability(2 months after surgery)
- Self-reported Quality of life(before surgery)
- Self-reported Quality of life(7-10 days after surgery)
- Self-reported Quality of life(2 months after surgery)
- Joint range of motion(before surgery)
- Joint range of motion(7-10 days after surgery)
- Joint range of motion(2 months after surgery)
- Muscle strength(before surgery)
- Muscle strength(7-10 days after surgery)
- Muscle strength(2 months after surgery)
- Upperlimb Disability(6 months after surgery)
- Neck Disability(6 months after surgery)
- Self-reported Quality of life(6 months after surgery)
- Joint range of motion(6 months after surgery)
- Muscle strength(6 months after surgery)