Impact of Step Count Measured by Smartwatches on Treatment Response in Non-Metastatic HER2-Negative Breast Cancer Patients Receiving Neoadjuvant Therapy: A Multicenter Prospective Study

What this Trial Is About

Researchers are investigating how daily step counts measured by Huawei Fit 2 smartwatches relate to treatment response in female patients aged 18 and older with non-metastatic HER2-negative breast cancer receiving neoadjuvant systemic therapy. This prospective multicenter observational study aims to understand if physical activity and digital health metrics can predict pathological response during treatment. The study also explores sleep quality, quality of life, perioperative outcomes, and the feasibility of continuous smartwatch monitoring. Participants will receive a Huawei Fit 2 smartwatch within the first week of starting their neoadjuvant systemic therapy. They will wear the device throughout the treatment period, which lasts about 24 to 32 weeks, to continuously track step counts, activity intensity, sleep duration, and heart rate. Patient-reported outcomes on sleep quality and quality of life will be collected using validated questionnaires at baseline and after completing treatment. Surgery will follow the therapy to determine pathological response. During the study, researchers will assess pathological complete response and tumor regression scores at surgery. Participants will complete the Pittsburgh Sleep Quality Index and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire before and after therapy. The study monitors adherence to smartwatch use and collects data to evaluate associations between physical activity, sleep, quality of life, and treatment outcomes, with total participation lasting the duration of therapy up to surgery.

Step Count and Treatment Response in Neoadjuvant Breast Cancer