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

NCT06608446 | Recruiting

• 1 other identifier: 2023.032
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (24)

• Upper limb pain

  before surgery

• Upper limb pain

  7-10 days after surgery

• Upper limb pain

  2 months after surgery

• Upper limb pain

  6 months after surgery

• Neck Disability

  before surgery

Study Arms (2)

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.

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.

Other: Standard Care

Interventions

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.

Telerehabilitation

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.

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of breast cancer
• Having undergone quadrantectomy or mastectomy surgery
• Age \> 18 years
• Signature of informed consent

You may not qualify if:

• Neurological deficits with sensorimotor impairment of the upper limb
• Cognitive deficits that prevent the completion of questionnaires (MMSE\>24)

Sponsors & Collaborators

• Fondazione Policlinico Universitario Campus Bio-Medico: lead

Study Sites (1)

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, Roma, 00128, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Telerehabilitation; Standard of Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration; Quality Indicators, Health Care; Quality of Health Care; Health Care Quality, Access, and Evaluation

Central Study Contacts

Silvia Sterzi, MD

CONTACT

+390622541624; s.sterzi@policlinicocampus.it

Marco Bravi, DPT

CONTACT

+390622541646; m.bravi@policlinicocampus.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the evaluators do not know the treatment group of the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-profit blinded randomized controlled interventional single-center pilot study.

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start: May 15, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)