Step Count and Treatment Response in Neoadjuvant Breast Cancer
NCT ID: NCT07162675
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
82 participants
OBSERVATIONAL
2025-09-08
2026-03-29
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Ankara Etlik City Hospital
OTHER_GOV
Responsible Party
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Galip Can Uyar
Medical Oncologist
Principal Investigators
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Galip Can Uyar, MD
Role: PRINCIPAL_INVESTIGATOR
Ankara Etlik City Hospital
Orhun Akdoğan, MD
Role: PRINCIPAL_INVESTIGATOR
Gazi University Medical Oncology Departmant, Ankara
Locations
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Etlik City Hospital, Medical Oncology Department
Ankara, Yenimahalle, Turkey (Türkiye)
Gazi University Medical Oncology Department
Ankara, Çankaya, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AEŞH-BADEK2-2025-454
Identifier Type: OTHER
Identifier Source: secondary_id
AEŞH-BADEK2-2025-454
Identifier Type: -
Identifier Source: org_study_id
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