Design and Evaluation of the Effects of a Physical Therapy Program With Digital Support in Patients With Breast Cancer

NCT04837248 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-02-26

No results posted yet for this study

Summary

Breast cancer surgery usually results in reduced range of motion of the shoulder joint, weakness of the musculature and altered scapular kinematics during movement. These factors limit activities of daily living, so rehabilitation exercises help to restore function after shoulder surgery.

Women with breast cancer often have a life conditioned by the sequelae or morbidity secondary to the treatment of the disease and, despite the high cure rate, many patients are unable to regain their initial quality of life. Cancer therapies can leave physical, psychological and psychosocial sequelae, which may manifest themselves or persist even years after the end of treatment.

For all these reasons, patients who have undergone cancer treatment need physical rehabilitation as well as psychological and social care to support them in their new stage of life, and to optimise the rehabilitation programme, it is necessary to identify each patient's individual needs,

The digital support proposed in this study enables the development of a physiotherapy programme for patients with breast cancer in a situation of health crisis, which includes providing assistance, information, accompaniment, help and treatment to these patients in a comprehensive way, based on the biopsychosocial model.

Conditions

Interventions

OTHER

Active Comparator: Group 1. Conventional treatment

Patients will be treated using a physiotherapy programme without digital support. A written document with exercises and recommendations will be given to them on the first day. This booklet will detail the exercises they can do depending on their surgery and the weeks elapsed, as well as the recommendations adapted according to the needs identified in the motivational interview (MI). This is the treatment that is currently being applied in the hospital. The patient will carry out the treatment at home and will come back after 20 sessions for the corresponding assessment.

OTHER

Experimental: Group 2. Experimental treatment.

A digitally supported physiotherapy programme including: * Group session: expectations, interests, experiences with regard to their health problem and the consequences on their life, joint exercise and discussion with subsequent debate will be held. * Exercise session: each week, patients will find different exercise videos on the platform according to the phase of recovery in which each one of them is, having been previously evaluated in the group session. * Relaxation session: this will be carried out by means of audio that will be posted on the platform and that the patient will be able to perform simultaneously. * Empowerment session: audio sessions that will deal with those needs that frequently arise after breast surgery in their daily lives, focusing on limiting beliefs (e.g. fear of moving), positive thoughts and information extracted from the motivational interview that should be developed.

Sponsors & Collaborators

  • Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-02
Primary Completion
2024-10-28
Completion
2024-12-30

Countries

  • Spain

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04837248 on ClinicalTrials.gov