(UroToday.com) The 2025 European Society of Medical Oncology (ESMO) Annual Congress held in Berlin, Germany between, was host to the Poster Session. Francesca Jackson-Spence presented the e-poster The Feasibility of Wearable Devices to Assess Patient Reported Outcomes in Urothelial Cancer Trials: The DISCUS Substudy.
Wearable devices represent an innovative approach to assessing patient-reported outcomes (PROs) and quality of life (QoL) in oncology, offering potential advantages over traditional methods. However, data on their feasibility in patients receiving systemic anti-cancer therapy (SACT) remain limited. This analysis evaluated compliance and usage patterns of wearable devices and app-based QoL assessments among patients undergoing SACT.
Patients enrolled in the DISCUS trial (NCT06892860), a randomized phase II study comparing 3 vs 6 cycles of platinum chemotherapy plus avelumab in advanced bladder cancer, could voluntarily participate in a wearable device substudy. The DISCUS trial is open for recruitment at 45 sites in UK, Spain and France.
This substudy incorporated an app-based patient-reported outcome (PRO) questionnaire and a wearable device designed to measure step count, heart rate, heart rate variability, and peripheral oxygen saturation (as illustrated below). The analysis aimed to assess uptake and compliance with these digital assessments, defining compliance as wearing the device for at least 8 hours once per treatment cycle and completing at least one PRO questionnaire per cycle.
Among 186 patients in the main trial, 92 consented to the substudy, and 52 were successfully enrolled. Baseline characteristics of patients who consented to wearable substudy vs those who did not consent are shown below.
Among the 52 patients enrolled in the DISCUS wearable substudy, compliance with assessments was moderate. A total of 41 patients (79%) completed the app-based PRO questionnaire, while 29 patients (56%) met the compliance criteria for wearing the device. Overall, 29 patients (56%) successfully completed both assessments, demonstrating the feasibility of integrating wearable and app-based monitoring during systemic anti-cancer therapy.
The main barriers to compliance with wearable device assessments were connectivity issues (54%), followed by patient illness (13%), patient concerns (8%), missing data (8%), and forgetfulness (4%). For the app-based PRO questionnaire, the most frequent reasons for non-compliance were connectivity issues (34%), forgetfulness (25%), and patient concerns (17%). Additional challenges included site logistics, limited staff capacity for recruitment, and technological problems such as Bluetooth or mobile app connectivity, phone battery, or data/Wi-Fi issues.
Francesca Jackson-Spence conclude her presentation with the following key takeaways:
- This study highlights key challenges in patient participation and compliance within wearable device trials.
• Non-compliance was primarily related to technological barriers, such as difficulties using Bluetooth devices or mobile applications, concerns over data privacy, and the inability to access wearable data in real time.
• No demographic subgroup including age, gender, or race was identified as having poorer compliance, suggesting that adherence issues are broadly distributed across patient populations.
• The findings underscore the need for future studies to adopt more patient-centered designs, potentially allowing real-time data access and improved user support to enhance engagement and compliance.
Presented by: Francesca Jackson-Spence, MBChB, BMedSc, PGCAP, Clinical Research Fellow, Genitourinary Oncology, Barts Cancer Institute, Queen Mary University of London, London, England
Written by: Julian Chavarriaga, MD – Urologic Oncologist at Cancer Treatment and Research Center (CTIC) via Society of Urologic Oncology (SUO) Fellow at The University of Toronto. @chavarriagaj on Twitter during the 2025 European Society for Medical Oncology (ESMO) Annual Congress, Berlin, Germany, October 17–21, 2025