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NCT Number: NCT06608446

Effects of a Telerehabilitation Intervention in the Management of Complications After Breast Cancer Surgery

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, 00128, Italy

Location status: Recruiting

Location contact

Fabio Santacaterina, DPT

CONTACT

+390622541624

Marco Bravi, DPT

CONTACT

+390622541624

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Complications

    Time frame: 7-10 days after surgery

    Number of complications (i.e. axyllary web syndrome; lymphedema; persistent pain)

  2. Complications

    Time frame: 2 months after surgery

    Number of complications (i.e. axyllary web syndrome; lymphedema)

  3. Complications

    Time frame: 6 months after surgery

    Number of complications (i.e. axyllary web syndrome; lymphedema)

Secondary outcomes

  1. Upper limb pain

    Time frame: before surgery

    Pain assessed through the numeric pain rating scale (0-10)

  2. Upper limb pain

    Time frame: 7-10 days after surgery

    Pain assessed through the numeric pain rating scale (0-10)

  3. Upper limb pain

    Time frame: 2 months after surgery

    Pain assessed through the numeric pain rating scale (0-10)

  4. Upper limb pain

    Time frame: 6 months after surgery

    Pain assessed through the numeric pain rating scale (0-10)

  5. Neck Disability

    Time frame: before surgery

    Neck related disability assessed through the questionnaire Neck Disabiltiy Index Value range (0% min disability - 100% max disability)

  6. Neck Disability

    Time frame: 7-10 days after surgery

    Neck related disability assessed through the questionnaire Neck Disability Index Value range (0% min disability - 100% max disability)

  7. Neck Disability

    Time frame: 2 months after surgery

    Neck related disability assessed through the questionnaire Neck Disability Index Value range (0% min disability - 100% max disability)

  8. Neck Disability

    Time frame: 6 months after surgery

    Neck related disability assessed through the questionnaire Neck Disability Index Value range (0% min disability - 100% max disability)

  9. Upperlimb Disability

    Time frame: 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)

  10. Upperlimb Disability

    Time frame: 7-10 days after surgery

    Upperlimb related disability assessed through the questionnaire Disability of the arm, shoulder and hand (DASH) Value range (0% min disability - 100% max disability)

  11. Upperlimb Disability

    Time frame: 2 months after surgery

    Upperlimb related disability assessed through the questionnaire Disability of the arm, shoulder and hand (DASH) Value range (0% min disability - 100% max disability)

  12. Upperlimb Disability

    Time frame: 6 months after surgery

    Upperlimb related disability assessed through the questionnaire Disability of the arm, shoulder and hand (DASH) Value range (0% min disability - 100% max disability)

  13. Self-reported Quality of life

    Time frame: before surgery

    Impact on quality of life assessed through the questionnaire Short Form-36 Health Survey Value range (0 min QoL- 100 max QoL)

  14. Self-reported Quality of life

    Time frame: 7-10 days after surgery

    Impact on quality of life assessed through the questionnaire Short Form-36 Health Survey Value range (0 min QoL- 100 max QoL)

  15. Self-reported Quality of life

    Time frame: 2 months after surgery

    Impact on quality of life assessed through the questionnaire Short Form-36 Health Survey Value range (0 min QoL- 100 max QoL)

  16. Self-reported Quality of life

    Time frame: 6 months after surgery

    Impact on quality of life assessed through the questionnaire Short Form-36 Health Survey Value range (0 min QoL- 100 max QoL)

  17. Joint range of motion

    Time frame: before surgery

    upper limb and cervical range of motion assessed through digital goniometer

  18. Joint range of motion

    Time frame: 7-10 days after surgery

    upper limb and cervical range of motion assessed through digital goniometer

  19. Joint range of motion

    Time frame: 2 months after surgery

    upper limb and cervical range of motion assessed through digital goniometer

  20. Joint range of motion

    Time frame: 6 months after surgery

    upper limb and cervical range of motion assessed through digital goniometer

  21. Muscle strength

    Time frame: before surgery

    handgrip, shoulder and neck muscle strength assessed through handheld dynamometer

  22. Muscle strength

    Time frame: 7-10 days after surgery

    handgrip, shoulder and neck muscle strength assessed through handheld dynamometer

  23. Muscle strength

    Time frame: 2 months after surgery

    handgrip, shoulder and neck muscle strength assessed through handheld dynamometer

  24. Muscle strength

    Time frame: 6 months after surgery

    handgrip, shoulder and neck muscle strength assessed through handheld dynamometer

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Bravi, DPT

CONTACT

[email protected]

+390622541646

Silvia Sterzi, MD

CONTACT

[email protected]

+390622541624

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Campus Bio-Medico

Other

Registry information

Official study title

Effects of a Telerehabilitation Intervention in the Management of Complications After Breast Cancer Surgery: Randomized Controlled Trial

Acronym: LINFO

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2024
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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