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

Not Applicable

Recruiting

• Conditions: Breast Neoplasms

• Registration Number: NCT06608446
• Lead Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico

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.

Study Timeline

• Study Start: 2023-05-15
• Status Verified: 2024-07
• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-09-20
• Study First Posted: 2024-09-23
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-11
• Primary Completion: 2026-02
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Complications	6 months after surgery	Number of complications (i.e. axyllary web syndrome; lymphedema)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Campus Bio-Medico; 🇮🇹 Roma, Italy