Cediranib inhibits VEGFR1-3 with significant but treatable side effects of hypertension and diarrhea. High frequency of these events occurred in a trial of cediranib with olaparib (C+O). Effective control of these side effects is therefore important for C+O therapy. eCO, a cloud-based mobile medical device, was developed to provide secure capture, storage, and transmission of accurate BP and diarrhea data to aid in remote monitoring. Pts receive automated reminders and instructions for self-management based on severity. HCPs monitor pt status via a secure web portal and email alerts.
Pts enrolled in a Ph 2 study of C+O (NCT02345265) could opt to participate in this pilot study. Pts received eCO-based prompts, used eCO to record BP via a Bluetooth-linked BP cuff and to enter diarrheal events, and received eCO-based reminders and recommendations. Pts completed a 17-item usability and satisfaction questionnaire after 4 weeks of eCO use. The primary objective was to evaluate the feasibility, usability, and satisfaction of eCO use. Data were analyzed by Wilcoxon Rank Sum Analysis.
15 pts completed the pilot study. Pts indicated they felt closely monitored, connected with the healthcare team, involved in their own care, and satisfied with ease of learning and use of many eCO functions (alpha < .01). Pts were satisfied with diarrhea entry and finding past recommendations (alpha < .05) and were not satisfied with reporting diarrhea side effects. eCO captured 98.1% of expected BP values (94.2% direct upload; 5.8% manual entry). BP events (≥2 consecutive BP > 140/90 mmHg) occurred in 11 pts (6 with 1 event, 2 with 2 events, 3 with 3 events) with median duration 5 days (range 3-28 days). 12 pts reported 20 diarrhea events (range 1-4 events); median duration was 1.4 days (range 1.0-2.7 days); 31 entries were made (28 Gr 1, 3 Gr 2).
In this initial pilot, eCO captured accurate BP and diarrhea events from pts for remote monitoring. Pts reported overall usability and satisfaction with eCO, especially feeling closely monitored, more connected, involved in self-care and ease-of-use. Use of eCO in other studies is planned.
Clinical trial identification
Legal entity responsible for the study
National Cancer Institute
National Cancer Institute
J. Liu: Served on a Scientific Advisory Board and Consultant for AstraZeneca. D.M. O\'Malley: Scientific Advisory Board for AstraZeneca E. Strock, R. Phillips: Employee of Voluntis, Inc. K. Mari: Consultant/advisory role to Voluntis, Inc. B. Killam: Consulting/advisory role to AstraZeneca All other authors have declared no conflicts of interest.