Breast Cancer Females, Breast Neoplasm Malignant Female, Exercise, Sleep Quality, Smartwatches, Wearable Technology
Conditions
Keywords
neoadjuvant therapy, HER2-Negative Breast Cancer, Smartwatch, Step Count, Physical Activity, Patient-Reported Outcomes, Quality of Life (EORTC QLQ-C30)
Brief 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.
Interventions
DEVICEHuawei 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.
Sponsors
Ankara Etlik City Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 0-2. * Ability to provide informed consent.
Exclusion criteria
* 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 ≥3. * Pregnancy or breastfeeding. * Refusal or inability to use a smartwatch device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Response (pCR) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) Score | Baseline (within first week of therapy) to completion of neoadjuvant therapy (24-32 weeks). | Patient-reported questionnaire assessing global sleep quality. Score range: 0-21; higher scores indicate worse sleep quality. A cut-off \>5 defines poor sleep quality. A validated Turkish version is available. |
| EORTC QLQ-C30 Global Health and Functional Scales | From baseline (within first week of neoadjuvant therapy) to completion of neoadjuvant therapy (24-32 weeks). | European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30. Scores standardized to 0-100. Higher scores on functional scales represent better functioning; higher scores on symptom scales represent worse symptom burden. A validated Turkish version is available. |
Countries
Turkey (Türkiye)
Contacts
CONTACTGalip Can Uyar, MD
CONTACTÖmür Berna Öksüzoğlu, MD
PRINCIPAL_INVESTIGATORGalip Can Uyar, MD
Ankara Etlik City Hospital
PRINCIPAL_INVESTIGATOROrhun Akdoğan, MD
Gazi University Medical Oncology Departmant, Ankara
Outcome results
None listed