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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasms
• Intervention / Treatment: Other: Telerehabilitation; Other: Standard Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 155
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Silvia Sterzi, MD; Phone Number: +390622541624; Email: s.sterzi@policlinicocampus.it
• Study Contact Backup: Name: Marco Bravi, DPT; Phone Number: +390622541646; Email: m.bravi@policlinicocampus.it

Study Locations

• Italy
  • Roma
    • Roma, Roma, Italy, 00128
      • Recruiting
      • Fondazione Policlinico Universitario Campus Bio-medico
      • Contact: Marco Bravi, DPT; Phone Number: +390622541624
      • Contact: Fabio Santacaterina, DPT; Phone Number: +390622541624

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 end of each exercise session.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Number of complications (i.e. axyllary web syndrome; lymphedema)	2 months after surgery
Complications	Number of complications (i.e. axyllary web syndrome; lymphedema)	6 months after surgery
Complications	Number of complications (i.e. axyllary web syndrome; lymphedema; persistent pain)	7-10 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Joint range of motion	upper limb and cervical range of motion assessed through digital goniometer	before surgery
Joint range of motion	upper limb and cervical range of motion assessed through digital goniometer	7-10 days after surgery
Joint range of motion	upper limb and cervical range of motion assessed through digital goniometer	2 months after surgery
Joint range of motion	upper limb and cervical range of motion assessed through digital goniometer	6 months after surgery
Upper limb pain	Pain assessed through the numeric pain rating scale (0-10)	before surgery
Upper limb pain	Pain assessed through the numeric pain rating scale (0-10)	7-10 days after surgery
Upper limb pain	Pain assessed through the numeric pain rating scale (0-10)	2 months after surgery
Upper limb pain	Pain assessed through the numeric pain rating scale (0-10)	6 months after surgery
Neck Disability	Neck related disability assessed through the questionnaire Neck Disabiltiy Index Value range (0% min disability - 100% max disability)	before surgery
Neck Disability	Neck related disability assessed through the questionnaire Neck Disability Index Value range (0% min disability - 100% max disability)	7-10 days after surgery
Neck Disability	Neck related disability assessed through the questionnaire Neck Disability Index Value range (0% min disability - 100% max disability)	2 months after surgery
Neck Disability	Neck related disability assessed through the questionnaire Neck Disability Index Value range (0% min disability - 100% max disability)	6 months after surgery
Upperlimb Disability	Upperlimb related disability assessed through the questionnaire Disability of the arm, shoulder and hand (DASH) Value range (0% min disability - 100% max disability)	before surgery
Upperlimb Disability	Upperlimb related disability assessed through the questionnaire Disability of the arm, shoulder and hand (DASH) Value range (0% min disability - 100% max disability)	7-10 days after surgery
Upperlimb Disability	Upperlimb related disability assessed through the questionnaire Disability of the arm, shoulder and hand (DASH) Value range (0% min disability - 100% max disability)	2 months after surgery
Upperlimb Disability	Upperlimb related disability assessed through the questionnaire Disability of the arm, shoulder and hand (DASH) Value range (0% min disability - 100% max disability)	6 months after surgery
Self-reported Quality of life	Impact on quality of life assessed through the questionnaire Short Form-36 Health Survey Value range (0 min QoL- 100 max QoL)	before surgery
Self-reported Quality of life	Impact on quality of life assessed through the questionnaire Short Form-36 Health Survey Value range (0 min QoL- 100 max QoL)	7-10 days after surgery
Self-reported Quality of life	Impact on quality of life assessed through the questionnaire Short Form-36 Health Survey Value range (0 min QoL- 100 max QoL)	2 months after surgery
Self-reported Quality of life	Impact on quality of life assessed through the questionnaire Short Form-36 Health Survey Value range (0 min QoL- 100 max QoL)	6 months after surgery
Muscle strength	handgrip, shoulder and neck muscle strength assessed through handheld dynamometer	before surgery
Muscle strength	handgrip, shoulder and neck muscle strength assessed through handheld dynamometer	7-10 days after surgery
Muscle strength	handgrip, shoulder and neck muscle strength assessed through handheld dynamometer	2 months after surgery
Muscle strength	handgrip, shoulder and neck muscle strength assessed through handheld dynamometer	6 months after surgery

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Health Services Administration; Delivery of Health Care; Health Care Quality, Access, and Evaluation; Therapeutics; Quality of Health Care; Quality Indicators, Health Care; Patient Care; Health Services; Health Care Facilities Workforce and Services; Rehabilitation; Aftercare; Continuity of Patient Care; Telemedicine; Patient Care Management; Standard of Care; Telerehabilitation
• Other Study ID Numbers: 2023.032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No