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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telerehabilitation | Experimental | 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. |
|
| Standard care | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telerehabilitation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Number of complications (i.e. axyllary web syndrome; lymphedema; persistent pain) | 7-10 days after surgery |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silvia Sterzi, MD | Contact | +390622541624 | s.sterzi@policlinicocampus.it | |
| Marco Bravi, DPT | Contact | +390622541646 | m.bravi@policlinicocampus.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Campus Bio-Medico | Recruiting | Roma | Roma | 00128 | Italy |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000069350 | Telerehabilitation |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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Non-profit blinded randomized controlled interventional single-center pilot study.
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the evaluators do not know the treatment group of the patients.
|
| Standard Care | Other | 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. |
|
| 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 |
| 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 |
| 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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D013812 |
| Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |