A Multicenter Prospective Study: The Impact of Step Count Measured by Smartwatches on Treatment Response in Non-Metastatic HER2-Negative Breast Cancer Patients Receiving Neoadjuvant Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Pathological Complete Response (pCR)
研究概览
简要总结
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.
详细描述
Physical activity and sleep quality are important prognostic factors in oncology, but objective and continuous monitoring during neoadjuvant systemic therapy is limited. Wearable devices provide non-invasive, real-time data on step counts, heart rate, and sleep. This study will evaluate whether daily step counts and digital health metrics predict pathological response in non-metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer.
Primary Objective: To assess the association between daily step counts and pathological response, including pathological complete response (pCR, defined as no residual invasive carcinoma in the breast and axillary nodes) and Miller-Payne score (range 1-5; higher scores indicate greater regression).
Secondary Objectives: To explore associations between physical activity and sleep quality (Pittsburgh Sleep Quality Index, PSQI), quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30, EORTC QLQ-C30), and perioperative outcomes; and to evaluate feasibility and adherence to smartwatch monitoring.
Methods: This is a multicenter prospective observational cohort study enrolling 82 female patients aged ≥18 years with non-metastatic HER2-negative breast cancer scheduled to receive neoadjuvant systemic therapy followed by surgery. Smartwatches (Huawei Fit 2) will continuously monitor activity, sleep, and heart rate. Questionnaires will be administered at baseline and at the end of treatment.
PSQI: Global score 0-21; higher scores indicate worse sleep quality; a cut-off >5 defines poor sleep. A validated Turkish version is available.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged ≥18 years.
- •Pathologically confirmed non-metastatic HER2-negative breast cancer.
- •Candidates scheduled to receive neoadjuvant systemic therapy followed by surgery.
- •ECOG performance status 0-
- •Ability to provide informed consent.
排除标准
- •Metastatic breast cancer at diagnosis.
- •HER2-positive breast cancer.
- •Previous systemic therapy for current breast cancer.
- •Severe comorbidities limiting mobility or physical activity (e.g., advanced neurologic or musculoskeletal disorders).
- •ECOG performance status ≥
- •Pregnancy or breastfeeding.
- •Refusal or inability to use a smartwatch device.
研究组 & 干预措施
Neoadjuvant HER2-Negative Breast Cancer Patients
This cohort includes female patients aged ≥18 years with non-metastatic, HER2-negative breast cancer who are scheduled to receive neoadjuvant systemic therapy followed by surgery.
干预措施: Huawei Fit 2 Smartwatch (Device)
结局指标
主要结局
Pathological Complete Response (pCR)
时间窗: From initiation of neoadjuvant therapy to the date of surgery (expected range: 24-32 weeks after treatment initiation).
Defined as the absence of residual invasive carcinoma in the breast and axillary lymph nodes at surgery. Pathological response will be evaluated after completion of neoadjuvant systemic therapy.
Miller-Payne Tumor Regression Score
时间窗: From initiation of neoadjuvant therapy to the date of surgery (expected range: 24-32 weeks after treatment initiation).
Histopathological regression grading system ranging from 1 (minimal regression) to 5 (complete disappearance of invasive cancer). Higher scores indicate greater regression.
次要结局
- Pittsburgh Sleep Quality Index (PSQI) Score(Baseline (within first week of therapy) to completion of neoadjuvant therapy (24-32 weeks).)
- EORTC QLQ-C30 Global Health and Functional Scales(From baseline (within first week of neoadjuvant therapy) to completion of neoadjuvant therapy (24-32 weeks).)
研究者
Galip Can Uyar
Medical Oncologist
Ankara Etlik City Hospital