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Recruiting Not applicable NCT06608446

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

No applicable phase (e.g. observational)
Conditions: Breast Neoplasms

Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico

trial.available_in: БГ
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.
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.
Who can participate
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)
Interventions
Telerehabilitation
OTHER
Standard Care
OTHER
Locations 1
Italy (1)
Fondazione Policlinico Universitario Campus Bio-Medico
Roma , Roma
Marco Bravi, DPT
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
18 Years
Healthy volunteers
No
Start date
15.05.2023
Completion date
30.07.2026
Registry ID
NCT06608446
Source
clinicaltrials.gov
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