Trials / Recruiting

RecruitingNCT07162675

Step Count and Treatment Response in Neoadjuvant Breast Cancer

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

Status: Recruiting
Phase: —
Study type: Observational
Enrollment: 82 (estimated)

Sponsor: Ankara Etlik City Hospital · Other Government
Sex: Female
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. EORTC QLQ-C30: Standardized 0-100 scoring system; higher scores on functional scales indicate better functioning, while higher scores on symptom scales indicate greater symptom burden. A validated Turkish version is available. Pathological response will be determined at surgery using pCR and Miller-Payne criteria. Sample Size and Statistics: A priori power analysis (effect size d = 0.5, α = 0.05, power = 0.80) indicates a minimum of 82 patients. Regression analyses and subgroup evaluations will test associations with step counts, questionnaire scores, and perioperative outcomes. Significance: This study (NEOBRE-STEP) is among the first multicenter efforts to integrate wearable health monitoring into breast cancer supportive care. By combining objective activity and sleep data with validated patient-reported outcomes, the study may provide new prognostic insights and support the integration of digital health tools into oncology practice.

Conditions

Interventions

Type	Name	Description
DEVICE	Huawei Fit 2 Smartwatch	Participants will receive a Huawei Fit 2 smartwatch within the first week of initiating neoadjuvant systemic therapy. The device will be worn throughout the treatment period to continuously monitor step counts, physical activity intensity, sleep duration, and heart rate. It is used solely for non-invasive monitoring and does not alter the standard oncological treatment.

Timeline

Start date: 2025-09-08
Primary completion: 2026-08-29
Completion: 2026-08-29
First posted: 2025-09-09
Last updated: 2026-02-20

Locations

2 sites across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07162675. Inclusion in this directory is not an endorsement.