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Клиническое исследование

Step Count and Treatment Response in Neoadjuvant Breast Cancer

NCT: NCT07162675 · RECRUITING

NCT IDNCT07162675
СтатусRECRUITING
Дата начала2025-09-08
Завершение2027-02-15
SponsorAnkara Etlik City Hospital (OTHER_GOV)
First posted
Last updated

Краткое описание

This prospective multicenter observational study (NEOBRE-STEP) investigates the impact of daily step counts, measured by Huawei Fit 2 smartwatches, on treatment response in patients with non-metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer undergoing neoadjuvant systemic therapy. Patients will wear smartwatches to continuously record step counts, activity intensity, sleep, and heart rate. Patient-reported outcomes, including sleep quality (Pittsburgh Sleep Quality Index, PSQI) and quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30, EORTC QLQ-C30), will be assessed at baseline and after treatment. The primary outcomes are pathological complete response (pCR) and Miller-Payne score. Secondary outcomes include sleep quality, quality of life, perioperative outcomes, and feasibility of smartwatch monitoring.

Официальный источник

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