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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFondazione Policlinico Universitario Campus Bio-Medico

About this 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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

diagnosis of breast cancer

Having undergone quadrantectomy or mastectomy surgery

Age > 18 years

Signature of informed consent

Disqualifiers

Neurological deficits with sensorimotor impairment of the upper limb

Cognitive deficits that prevent the completion of questionnaires (MMSE>24)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Telerehabilitation

    Other intervention

    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 intervention

    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.

Treatment groups

155 Participants
are divided into 2 treatment groups
Group A: TelerehabilitationExperimental treatment 1 intervention
Group B: Standard careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Complications

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

Time frame
7-10 days after surgery
2

Complications

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

Time frame
2 months after surgery
3

Complications

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

Time frame
6 months after surgery

Secondary outcomes

1

Upper limb pain

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

Time frame
before surgery
2

Upper limb pain

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

Time frame
7-10 days after surgery
3

Upper limb pain

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

Time frame
2 months after surgery
4

Upper limb pain

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

Time frame
6 months after surgery

Other outcomes

Sponsors and contacts

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