A Digital Home-Based Health Care Center for Remote Monitoring of Side Effects During Breast Cancer Therapy: Prospective, Single-Arm, Monocentric Feasibility Study.

Abstract

Background: The introduction of oral anticancer therapies has, at least partially, shifted treatment from clinician-supervised hospital care to patient-managed home regimens. However, patients with breast cancer receiving oral cyclin-dependent kinase 4/6 inhibitor therapy still require regular hospital visits to monitor side effects. Telemonitoring has the potential to reduce hospital visits while maintaining quality care.

Objective: This study aims to develop a digital home-based health care center (DHHC) for acquiring electrocardiograms (ECGs), white blood cell (WBC) counts, side effect photo documentation, and patient-reported quality of life (QoL) data.

Methods: The DHHC was set up using an Apple Watch Series 6 (ECG measurements), a HemoCue WBC DIFF Analyzer (WBC counts), an iPhone SE (QoL assessments and photo documentation), a TP-Link M7350-4G Wi-Fi router, and a Raspberry Pi 4 Model B. A custom-built app stored and synchronized remotely collected data with the clinic. The feasibility and acceptance of the DHHC among patients with breast cancer undergoing cyclin-dependent kinase 4/6 inhibitor therapy were evaluated in a prospective, single-arm, monocentric study. Patients (n=76) monitored side effects-ECGs, WBC counts, photo documentation, and QoL-at 3 predefined time points: study inclusion (on-site), day 14 (remote), and day 28 (remote). After the study completion, patients completed a comprehensive questionnaire on user perception and feasibility. Adherence to scheduled visits, the success rate of the data transfer, user perception and feasibility, and the clinical relevance of remote measurements were evaluated.

Results: Mean adherence to the planned remote visits was 63% on day 14 and 37% on day 28. ECG measurements were performed most frequently (day 14: 57/76, 75%; day 28: 31/76, 41%). The primary patient-reported reason for nonadherence was device malfunction. The expected versus the received data transfer per patient was as follows: ECGs: 3 versus 3.04 (SD 1.9); WBC counts: 3 versus 2.14 (SD 1.14); QoL questionnaires: 3 versus 2.5 (SD 1.14); and photo documentation: 6 versus 4.4 (SD 3.36). Among patients, 81% (55/68) found ECG measurements easy, 82% (55/67) found photo documentation easy, and 48% (33/69) found WBC measurements easy. Additionally, 61% (40/66) of patients felt comfortable with self-monitoring and 79% (54/68) were willing to integrate remote monitoring into their future cancer care. Therapy-induced decreased neutrophil count was successfully detected (P<.001; mean baseline: 4.3, SD 2.2, ×109/L; on-treatment: 1.8, SD 0.8, ×109/L). All-grade neutropenia and corrected QT interval prolongations were detected in 80% (55/68) and 2% (1/42) of patients, respectively.

Conclusions: Adherence to scheduled remote visits was moderate, with nonadherence primarily attributed to device-related complications, which may have also affected the success rate of data transfer. Overall, patients considered remote monitoring useful and feasible. The prevalence of reported adverse events was comparable to existing literature, suggesting clinical potential. This initial feasibility study highlights the potential of the DHHC.