Breast Cancer Female
Conditions
Keywords
breast cancer, telerehabilitation, telemedicine, digital health, exercise program, physiotherapy
Brief summary
The goal of this clinical trial is to compare the effectiveness of digital physiotherapy via Trak telerehabilitation with conventional home-based exercises in women who have undergone axillary lymph node removal (axillary lymphadenectomy) as part of breast cancer treatment. Researchers will compare the Trak telerehabilitation platform to a standard home exercise protocol to assess the impact on shoulder mobility, treatment adherence, and overall patient satisfaction. Participants will undergo a 4-week home-based rehabilitation using Trak (treatment group) or follow a paper-based exercise protocol (control group) and attend follow-up visits to measure shoulder mobility and any necessary adjustments in treatment.
Detailed description
Women undergoing axillary lymph node removal as part of breast cancer therapy will be recruited. All participants will complete a baseline assessment before being randomly assigned (1:1) to the experimental (telerehabilitation) or control (paper-based exercises) group. Throughout the study, all participants will have follow-up assessments at specific intervals: * Baseline (V0), initial screening: Health assessments, ensuring their individual needs are met, and written informed consent immediately after the intervention. * 15 Days Post-Assignment (V1): Initial evaluation of shoulder mobility and assessment for factors like scarring, seroma, and auxiliary cord. * 3-4 Weeks Post-Assignment (V2): Radiation oncology consultation to assess the mobility metrics and determine whether radiotherapy is necessary or if a delay is required. * 8 weeks Post-Assessment (V3): The healthcare professional will meet to evaluate shoulder abduction in the affected arm. For patients in the Trak group, the professional will access objective rehabilitation data and metrics from the platform. * 14 Weeks Post-V1 (V3): Final evaluation of shoulder abduction and assessment of functional recovery (mobility level recovered by the patient). It will also be recorded if the patient needs to receive adjuvant chemotherapy (after surgery). The professional will be able to evaluate each patient's evolution, adherence, and condition. During the visit, the patients will respond to a survey on the technique assigned for rehabilitation (either with the exercises or using Trak). Patients from the experimental group will use the TRAK telerehabilitation platform (https://www.trakphysio.com/es/) at home for 4 weeks. Patients from the control group will follow a paper-based exercise regimen at home for the same time. Primary outcomes include shoulder abduction and flexion mobility (first and last visit), adherence to the rehabilitation protocol, satisfaction with the Trak platform (internal survey), and the need for adjuvant chemotherapy. Both groups will complete initial and final assessments on paper, and data will be analyzed for efficacy, adherence, and patient satisfaction.
Interventions
OTHERTrak exercise prescription protocol at home
Online exercise protocol using the TRAK software. The patient will undergo 4 weeks of an exercise prescription protocol based on shoulder mobility exercises.
OTHERConventional rehabilitation plan at home
Treatment is based on therapeutic exercise following a conventional rehabilitation plan on paper. The patient will undergo 4 weeks of an exercise prescription protocol based on mobility exercises.
Sponsors
Trak Health Solutions S.L.
Biogipuzkoa Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The study will not be blinded to patients because masking the use of an application is impossible. However, mobility assessment will be blinded, so the researchers involved in this task will not know the patient group.
Intervention model description
The allocation of patients to treatment groups will be performed randomly. IIS Biodonostia will generate the randomization list using R software and enter it into REDCap. This ensures that researchers will neither know nor be able to decide which group each study patient will be randomized to. * Control group: The exercise protocol will be completed using printed paper sheets. * Treatment group: The exercise protocol is to be completed using the TRAK tool.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients equal to or older than 18 years old. * Patient undergoing axillary lymph node removal (axillary lymphadenectomy) as part of breast cancer therapy. * Patients with a tablet, smartphone, or laptop who can use electronic devices (or with family support). * Patient with an e-mail account (or willing to generate a new one). * Signed the informed consent.
Exclusion criteria
* Patient with cognitive restriction * Patient receiving adjuvant chemotherapy (after lymphadenectomy) * Patient with previous shoulder-limiting pathology (cuff tear, chronic pain, shoulder fracture with sequelae of limited mobility) * Patient who has undergone previous surgery on the same shoulder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder abduction mobility | 2-3 days; 15 days; 4-5 and 14 weeks after the surgery | Active shoulder abduction the patient is able to do actively measurded with a goniometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder flexion mobility | 2-3 days; 15 days; 4-5 and 14 weeks after the surgery | Active shoulder abduction the patient is able to do actively measurded with a goniometer |
| TRAK designed tool satisfaction questionnaire | 14 weeks | The trak satisfaction questionnaire was provided to patients in Spanish and consists of 12 questions about usability, usefulness and satisfaction as well as a suggestions section at the end. The score ranges from 0 to 12, with 0 being no satisfaction and 12 being a maximum level of satisfaction. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORMikel Zabaleta Sistiaga
Donostia University Hospital
Outcome results
None listed