Effects of a Telerehabilitation Intervention in the Management of Complications After Breast Cancer Surgery

Official title

Effects of a Telerehabilitation Intervention in the Management of Complications After Breast Cancer Surgery: Randomized Controlled Trial

Overview

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.

Detailed description

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.

Interventions

• Other Telerehabilitation
  The telerehabilitation intervention will begin from 10 days post-surgery, the operation will be carried out at home from Monday to Friday via the TeleHab device (Vald Performance) up to 2 months after the 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. The progression of the exercises will be carried out taking into account the pain and fatigue recorded by the patient at the
• Other Standard Care
  Standard care intervention follow the usual treatment according to current clinical practice, no structured physiotherapeutic interventions will be carried out. It 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 immed

Primary outcome measures

• Complications [Time frame: 7-10 days after surgery]
• Complications [Time frame: 2 months after surgery]
• Complications [Time frame: 6 months after surgery]

Secondary outcome measures (12)

• Upper limb pain [Time frame: before surgery]
• Upper limb pain [Time frame: 7-10 days after surgery]
• Upper limb pain [Time frame: 2 months after surgery]
• Upper limb pain [Time frame: 6 months after surgery]
• Neck Disability [Time frame: before surgery]
• Neck Disability [Time frame: 7-10 days after surgery]
• Neck Disability [Time frame: 2 months after surgery]
• Neck Disability [Time frame: 6 months after surgery]
• Upperlimb Disability [Time frame: before surgery]
• Upperlimb Disability [Time frame: 7-10 days after surgery]
• Upperlimb Disability [Time frame: 2 months after surgery]
• Upperlimb Disability [Time frame: 6 months after surgery]

Eligibility criteria

Inclusion criteria

• diagnosis of breast cancer
• Having undergone quadrantectomy or mastectomy surgery
• Age > 18 years
• Signature of informed consent

Exclusion criteria

• Neurological deficits with sensorimotor impairment of the upper limb
• Cognitive deficits that prevent the completion of questionnaires (MMSE>24)

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

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Italy · 1 center

• Fondazione Policlinico Universitario Campus Bio-Medico — Roma

Identifiers

NCT: NCT06608446 · 2023.032

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗