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| ID | Type | Description | Link |
|---|---|---|---|
| AEŞH-BADEK2-2025-454 | Other Identifier | Ankara Etlik City Hospital Scientific Research Ethics Committee |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Huawei Fit 2 Smartwatch | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response (pCR) | 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. | From initiation of neoadjuvant therapy to the date of surgery (expected range: 24-32 weeks after treatment initiation). |
| Miller-Payne Tumor Regression Score | Histopathological regression grading system ranging from 1 (minimal regression) to 5 (complete disappearance of invasive cancer). Higher scores indicate greater regression. | From initiation of neoadjuvant therapy to the date of surgery (expected range: 24-32 weeks after treatment initiation). |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) Score | 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. | Baseline (within first week of therapy) to completion of neoadjuvant therapy (24-32 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Device-Measured Physical Activity Intensity | Minutes per day spent in moderate-to-vigorous physical activity, including bouts ≥10 minutes, measured by smartwatch. | From treatment initiation to end of neoadjuvant therapy (up to 32 weeks). |
| Resting Heart Rate (RHR) |
Inclusion Criteria:
Exclusion Criteria:
Only biologically female patients with pathologically confirmed non-metastatic HER2-negative breast cancer are eligible for participation.
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The study population will consist of eighty-two female patients with non-metastatic, HER2-negative breast cancer who are scheduled to receive neoadjuvant systemic therapy followed by surgery. All participants will be recruited consecutively from the Department of Medical Oncology at Ankara Etlik City Hospital and Gazi University Faculty of Medicine.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Galip Can Uyar, MD | Contact | +905065963812 | g.can_uyar@hotmail.com | |
| Ömür Berna Öksüzoğlu, MD | Contact | +905055718475 | bernaoksuzoglu@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Galip Can Uyar, MD | Ankara Etlik City Hospital | Principal Investigator |
| Orhun Akdoğan, MD | Gazi University Medical Oncology Departmant, Ankara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Etlik City Hospital, Medical Oncology Department | Recruiting | Ankara | Yenimahalle | 06210 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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| EORTC QLQ-C30 Global Health and Functional Scales | 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. | From baseline (within first week of neoadjuvant therapy) to completion of neoadjuvant therapy (24-32 weeks). |
Average weekly resting heart rate measured by smartwatch (beats per minute). Changes from baseline will be evaluated. |
| From treatment initiation to end of neoadjuvant therapy (up to 32 weeks). |
| Device-Measured Sleep Duration | Nightly sleep duration derived from smartwatch recordings, measured in hours per night. | From device allocation to end of neoadjuvant therapy (up to 32 weeks). |
| Device-Measured Sleep Efficiency | Proportion of time asleep relative to time in bed, derived from smartwatch recordings, expressed as percentage (%). | From device allocation to end of neoadjuvant therapy (up to 32 weeks). |
| Correlation Between Device-Measured Sleep Duration and PSQI Score | Statistical correlation between nightly sleep duration and PSQI scores. | From device allocation to end of neoadjuvant therapy (up to 32 weeks). |
| Correlation Between Device-Measured Sleep Efficiency and Miller-Payne Score | Statistical correlation between sleep efficiency and histopathological regression grading. | From device allocation to surgery (up to 32 weeks). |
| Correlation Between Device-Measured Sleep Efficiency and PSQI Score | Statistical correlation between sleep efficiency and PSQI scores. | From device allocation to end of neoadjuvant therapy (up to 32 weeks). |
| Correlation Between Device-Measured Sleep Duration and Miller-Payne Score | Statistical correlation between nightly sleep duration and histopathological regression grading. | From device allocation to surgery (up to 32 weeks). |
| Correlation Between Device-Measured Sleep Duration and Pathological Complete Response (pCR) | Statistical correlation between nightly sleep duration and pathological complete response status. | From device allocation to surgery (up to 32 weeks). |
| Correlation Between Device-Measured Sleep Efficiency and Pathological Complete Response (pCR) | Statistical correlation between sleep efficiency and pathological complete response status. | From device allocation to surgery (up to 32 weeks). |
| Gazi University Medical Oncology Department | Recruiting | Ankara | Çankaya | Turkey (Türkiye) |
|
| D009422 |
| Nervous System Diseases |
| D001523 | Mental Disorders |