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Trial Title:
Effects of a Telerehabilitation Intervention in the Management of Complications After Breast Cancer Surgery
NCT ID:
NCT06608446
Condition:
Breast Neoplasms
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Non-profit blinded randomized controlled interventional single-center pilot study.
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Masking description:
the evaluators do not know the treatment group of the patients.
Intervention:
Intervention type:
Other
Intervention name:
Telerehabilitation
Description:
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.
Arm group label:
Telerehabilitation
Intervention type:
Other
Intervention name:
Standard Care
Description:
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.
Arm group label:
Standard care
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.
Criteria for 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)
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione Policlinico Universitario Campus Bio-Medico
Address:
City:
Roma
Zip:
00128
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Marco Bravi, DPT
Phone:
+390622541624
Contact backup:
Last name:
Fabio Santacaterina, DPT
Phone:
+390622541624
Start date:
May 15, 2023
Completion date:
May 2025
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Campus Bio-Medico
Agency class:
Other
Source:
Fondazione Policlinico Universitario Campus Bio-Medico
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06608446
