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

50 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

Inclusion Criteria4

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

Exclusion Criteria2

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

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.