Breast Neoplasms
Conditions
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.
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.
Sponsors
Fondazione Policlinico Universitario Campus Bio-Medico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
the evaluators do not know the treatment group of the patients.
Intervention model description
Non-profit blinded randomized controlled interventional single-center pilot study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 7-10 days after surgery | Number of complications (i.e. axyllary web syndrome; lymphedema; persistent pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Upper limb pain | before surgery | Pain assessed through the numeric pain rating scale (0-10) |
| Neck Disability | before surgery | Neck related disability assessed through the questionnaire Neck Disabiltiy Index Value range (0% min disability - 100% max disability) |
| Upperlimb Disability | before 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 | before 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 | before surgery | upper limb and cervical range of motion assessed through digital goniometer |
| Muscle strength | before surgery | handgrip, shoulder and neck muscle strength assessed through handheld dynamometer |
Countries
Italy
Contacts
CONTACTSilvia Sterzi, MD
CONTACTMarco Bravi, DPT
Outcome results
None listed