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

DESIGN: Single-centre, assessor-blinded, parallel-group, randomised controlled clinical trial. METHODS: The study will be carried out at the Ramon y Cajal hospital with 92 patients diagnosed and operated on for breast cancer. Patients who come to the consultation of the rehabilitation doctors will be assessed, considering the inclusion and exclusion criteria. Those who may be candidates will be informed about the study and referred to the physiotherapy department where the treatment orders for these patients will be received and an appointment will be made. This is the start of the recruitment phase. Those who meet the criteria and agree to participate in the study will be assigned an identification code and will be randomised into the two groups, the intervention group and the conventional treatment group. Patients who do not meet the inclusion criteria or refuse to participate in the study will receive conventional treatment. A 6-month pilot study will be conducted to better define patient identification, inclusion criteria, recruitment and adjustment of the intervention if required. Once the pilot study is completed, the intervention clinical trial will begin. A first analysis of all variables will be performed after the intervention phase of the trial, 6 weeks after inclusion in the study. An interim analysis will also be performed at 3 months in which the same variables as at 6 weeks will be assessed. This will be the main analysis of the study. The final analysis will be carried out 6 months after inclusion in the study, and this will conclude the follow-up phase.