Breast NeoplasmsLINFONCT06608446
Effects of a Telerehabilitation Intervention in the Management of Complications After Breast Cancer Surgery
A study testing Telerehabilitation in people with Breast Neoplasms, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2023to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of breast cancer
- Having undergone quadrantectomy or mastectomy surgery
- Age > 18 years
- Signature of informed consent
Who cannot join
- Neurological deficits with sensorimotor impairment of the upper limb
- Cognitive deficits that prevent the completion of questionnaires (MMSE>24)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, Roma, 00128
Marco Bravi, DPT, +390622541624
Fabio Santacaterina, DPT, +390622541624
About this study
Official title: Effects of a Telerehabilitation Intervention in the Management of Complications After Breast Cancer Surgery: Randomized Controlled Trial
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.
Read more
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.
Read the 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.
- Conditions
- Breast Neoplasms
- Being tested
- Telerehabilitation, Standard Care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationOther
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.
Standard CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Telerehabilitation |
| 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. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Number of complications (i.e. axyllary web syndrome; lymphedema; persistent pain)
Measured: 7-10 days after surgery
Complications
Number of complications (i.e. axyllary web syndrome; lymphedema)
Measured: 2 months after surgery
Complications
Number of complications (i.e. axyllary web syndrome; lymphedema)
Measured: 6 months after surgery
Secondary outcomes (24)
Upper limb pain
Pain assessed through the numeric pain rating scale (0-10)
Measured: before surgery
Upper limb pain
Pain assessed through the numeric pain rating scale (0-10)
Measured: 7-10 days after surgery
Upper limb pain
Pain assessed through the numeric pain rating scale (0-10)
Measured: 2 months after surgery
Upper limb pain
Pain assessed through the numeric pain rating scale (0-10)
Measured: 6 months after surgery
Neck Disability
Neck related disability assessed through the questionnaire Neck Disabiltiy Index Value range (0% min disability - 100% max disability)
Measured: before surgery
Neck Disability
Neck related disability assessed through the questionnaire Neck Disability Index Value range (0% min disability - 100% max disability)
Measured: 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)
Measured: 2 months after surgery
Neck Disability
Neck related disability assessed through the questionnaire Neck Disability Index Value range (0% min disability - 100% max disability)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 6 months after surgery
Joint range of motion
upper limb and cervical range of motion assessed through digital goniometer
Measured: before surgery
Joint range of motion
upper limb and cervical range of motion assessed through digital goniometer
Measured: 7-10 days after surgery
Joint range of motion
upper limb and cervical range of motion assessed through digital goniometer
Measured: 2 months after surgery
Joint range of motion
upper limb and cervical range of motion assessed through digital goniometer
Measured: 6 months after surgery
Muscle strength
handgrip, shoulder and neck muscle strength assessed through handheld dynamometer
Measured: before surgery
Muscle strength
handgrip, shoulder and neck muscle strength assessed through handheld dynamometer
Measured: 7-10 days after surgery
Muscle strength
handgrip, shoulder and neck muscle strength assessed through handheld dynamometer
Measured: 2 months after surgery
Muscle strength
handgrip, shoulder and neck muscle strength assessed through handheld dynamometer
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start15 May 2023
- Primary completion30 May 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-profit blinded randomized controlled interventional single-center pilot study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608446
- Sponsor's protocol ID
- 2023.032
- Acronym
- LINFO
- Status last verified
- Mar 2026
- First submitted
- 19 Sep 2024
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Telerehabilitation Intervention in the Management of Complications After Breast Cancer Surgery: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06608446
- Acronym / sponsor ID
- LINFO / 2023.032
- Conditions
- Breast Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-MedicoUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Non-profit blinded randomized controlled interventional single-center pilot study.
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation | Experimental | Other: TelerehabilitationIn 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 | Other: Standard CareStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of breast cancer
- Having undergone quadrantectomy or mastectomy surgery
- Age > 18 years
- Signature of informed consent
Key exclusion criteria (2 listed)
- Neurological deficits with sensorimotor impairment of the upper limb
- Cognitive deficits that prevent the completion of questionnaires (MMSE>24)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelerehabilitationThe 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. | Other | Telerehabilitation |
| Standard CareStandard 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. | Other | Standard care |
Primary outcome
Complications
Time frame: 7-10 days after surgery
Number of complications (i.e. axyllary web syndrome; lymphedema; persistent pain)
Complications
Time frame: 2 months after surgery
Number of complications (i.e. axyllary web syndrome; lymphedema)
Complications
Time frame: 6 months after surgery
Number of complications (i.e. axyllary web syndrome; lymphedema)
24 secondary outcomes
Upper limb pain
Time frame: before surgery
Upper limb pain
Time frame: 7-10 days after surgery
Upper limb pain
Time frame: 2 months after surgery
Upper limb pain
Time frame: 6 months after surgery
Neck Disability
Time frame: before surgery
Neck Disability
Time frame: 7-10 days after surgery
Neck Disability
Time frame: 2 months after surgery
Neck Disability
Time frame: 6 months after surgery
Upperlimb Disability
Time frame: before surgery
Upperlimb Disability
Time frame: 7-10 days after surgery
Upperlimb Disability
Time frame: 2 months after surgery
Upperlimb Disability
Time frame: 6 months after surgery
Self-reported Quality of life
Time frame: before surgery
Self-reported Quality of life
Time frame: 7-10 days after surgery
Self-reported Quality of life
Time frame: 2 months after surgery
Self-reported Quality of life
Time frame: 6 months after surgery
Joint range of motion
Time frame: before surgery
Joint range of motion
Time frame: 7-10 days after surgery
Joint range of motion
Time frame: 2 months after surgery
Joint range of motion
Time frame: 6 months after surgery
Muscle strength
Time frame: before surgery
Muscle strength
Time frame: 7-10 days after surgery
Muscle strength
Time frame: 2 months after surgery
Muscle strength
Time frame: 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation in people with Breast Neoplasms, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Sterzi, MD (+390622541624, s.sterzi@policlinicocampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: 7-10 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.