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

NCT ID: NCT06608446

Last Updated: 2025-05-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2026-05-31

Brief 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.

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.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Telerehabilitation

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: OTHER

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.

Interventions

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 end of each exercise session.

Intervention Type: 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 immediately after surgery.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Campus Bio-Medico

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, Roma, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Silvia Sterzi, MD

Role: CONTACT

s.sterzi@policlinicocampus.it

+390622541624

Marco Bravi, DPT

Role: CONTACT

+390622541646

Facility Contacts

Marco Bravi, DPT

Role: primary

+390622541624

Fabio Santacaterina, DPT

Role: backup

+390622541624

Other Identifiers

2023.032

Identifier Type: -

Identifier Source: org_study_id