Smart phone application for early detection of adverse clinical outcomes in solid malignancy: a pilot randomized controlled trial (Preprint)

BACKGROUND Using mobile in healthcare is modernizing Patient-Reported Outcomes (PRO) for patient-centered approach. Our study introduces a mobile application that combines IoT devices as a remote patient monitoring to enhance real-time communication and management between solid malignancy and healthcare providers. OBJECTIVE To evaluate the effectiveness of this mobile application on quality of life and compare emergency room visits in solid malignancy. METHODS A pilot randomized controlled trial was conducted on 30 patients with solid malignancies, recruited from an outpatient oncology clinic. The study compared remote monitoring via a mobile application and smartwatch plus conventional care with a physician as the care provider, to conventional care alone. The primary outcome was quality of life, assessed using the Functional Assessment of Cancer Therapy – General (FACT-G). The secondary outcome was the cumulative number of emergency room visits. An additional finding was literacy of side effects. Quality of life and emergency room visits were collected and analyzed at 1, 3, and 6 months, while literacy of side effects was assessed at 3 months. RESULTS Of the 30 participants, 26 completed all 6 months of follow-up assessments (Intervention: 13/15, 86.6%; control: 13/15, 86.6%). At 6 months, the intervention group had higher total quality of life scores (84.23 ± 12.128) compared to the control group (77.15 ± 14.002), though this was not statistically significant (P=.073). Notably, statistically significant improvements were observed in the intervention group in physical well-being at 1 to 3 months within group (P=.010) and at 6 months between groups (P=.048), and in emotional well-being at 1 to 6 months (P=.032). Functional well-being was preserved in the intervention group, while a decline was observed in the control group, with a significant within-group decline from baseline to 3 months (P=.033). Social and family well-being did not differ between groups across time. The intervention group had no emergency room visits, compared to three in the control group (P=.070). The literacy of side effects was not significantly different (P=.318). CONCLUSIONS This study suggests that a smartphone application with wearable IoT support has the potential to improve quality of life in cancer patients. A clinically meaningful trend toward better outcomes was observed, with significant improvements in physical and emotional well-being, along with the prevention of functional deterioration. Fewer emergency room visits in the intervention group suggest effectiveness in remote patient monitoring (RPM) for the early detection of adverse clinical outcomes, supporting a more proactive approach to cancer care. These findings warrant further evaluation in larger, adequately powered trials. CLINICALTRIAL Thai Clinical Trials Registry TCTR20230331002; https://www.thaiclinicaltrials.org/show/TCTR20230331002