Clinical trial NCT06608446: Effects of a Telerehabilitation Intervention in the Management of Complications After Breast Cancer Surgery
Official title: Effects of a Telerehabilitation Intervention in the Management of Complications After Breast Cancer Surgery: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasms
Lead sponsor: Fondazione Policlinico Universitario Campus Bio-Medico
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-profit blinded randomized controlled interventional single-center pilot study.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Complications
timeFrame: 7-10 days after surgery
measure: Complications
timeFrame: 2 months after surgery
measure: Complications
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Upper limb pain
timeFrame: before surgery
measure: Upper limb pain
timeFrame: 7-10 days after surgery
measure: Upper limb pain
timeFrame: 2 months after surgery
measure: Upper limb pain
timeFrame: 6 months after surgery
measure: Neck Disability
timeFrame: before surgery
measure: Neck Disability
timeFrame: 7-10 days after surgery
measure: Neck Disability
timeFrame: 2 months after surgery
measure: Neck Disability
timeFrame: 6 months after surgery
measure: Upperlimb Disability
timeFrame: before surgery
measure: Upperlimb Disability
timeFrame: 7-10 days after surgery
measure: Upperlimb Disability
timeFrame: 2 months after surgery
measure: Upperlimb Disability
timeFrame: 6 months after surgery
measure: Self-reported Quality of life
timeFrame: before surgery
measure: Self-reported Quality of life
timeFrame: 7-10 days after surgery
measure: Self-reported Quality of life
timeFrame: 2 months after surgery
measure: Self-reported Quality of life
timeFrame: 6 months after surgery
measure: Joint range of motion
timeFrame: before surgery
measure: Joint range of motion
timeFrame: 7-10 days after surgery
measure: Joint range of motion
timeFrame: 2 months after surgery
measure: Joint range of motion
timeFrame: 6 months after surgery
measure: Muscle strength
timeFrame: before surgery
measure: Muscle strength
timeFrame: 7-10 days after surgery
measure: Muscle strength
timeFrame: 2 months after surgery
measure: Muscle strength
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Campus Bio-Medico
Study officials:
References: