RecruitingNot ApplicableNCT06608446

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

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

Sponsor

Fondazione Policlinico Universitario Campus Bio-Medico

Enrollment

155 participants

Start Date

May 15, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Neoplasms

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a telerehabilitation program — delivered remotely via technology — to help manage complications that can occur after breast cancer surgery, such as arm stiffness, lymphedema (arm swelling), and limited shoulder movement. The goal is to make effective physical rehabilitation more accessible from home. **You may be eligible if...** - You have been diagnosed with breast cancer - You have had a lumpectomy (partial breast removal) or mastectomy (full breast removal) - You are older than 18 years - You are willing to give consent to participate **You may NOT be eligible if...** - You have neurological problems causing weakness or sensation loss in your arm - You have cognitive difficulties that prevent you from completing questionnaires Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTelerehabilitation

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 end of each exercise session.

OTHERStandard 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 immediately after surgery.