Accepted for/Published in: JMIR Cancer
Date Submitted: Jul 19, 2023
Open Peer Review Period: Jul 19, 2023 - Sep 13, 2023
Date Accepted: Mar 4, 2024
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
HidrateSpark™ 3, A Smart Water Bottle and Companion App to Improve Bladder-Filling Compliance in Prostate Cancer Patients Receiving Radiotherapy: A Single-arm Trial of Feasibility and Acceptability
ABSTRACT
Background:
Prostate cancer (PCa) patients undergoing radiation therapy (RT) need comfortably full bladders to reduce toxicities during treatment. Poor compliance is common with standard of care written/verbal instructions, leading to wasted patient value (PV) and clinic resources via poor throughput efficiency (TE).
Objective:
Herein, we assessed the feasibility and acceptability of a smartphone-based behavioral intervention (SBI) to improve bladder filling compliance, and methods for quantifying PV and TE.
Methods:
Eighteen PCa patients were enrolled in a single-institution, closed-access, single-arm feasibility trial. The SBI consists of a fully automated smart water bottle and smartphone app. Both pieces alert the patient to empty his bladder and drink a personalized volume goal (VG), based on simulation bladder volume, 1.25 hrs prior to scheduled RT. Patients were trained to adjust their VG and notification times to achieve comfortably full bladders. Primary endpoint was met if qualitative (QLC) and quantitative compliance (QNC) >80%. For QLC, patients were asked if they prepared their bladders before daily RT. QNC was met if bladder volumes on daily cone-beam tomography were >75% of the simulation’s volume. The Service User Technology Acceptability Questionnaire (SUTAQ) was given in-person pre- and post-SBI. Additional acceptability and engagement endpoints were met if >3.00/5.00 across 4 domains on the SUTAQ and >80% of patients used the device >50% of the time, respectively. Finally, the impact of SBI on PV and TE were measured by time spent in clinic and on the linear accelerator (linac), respectively and contrasted with matched controls.
Results:
QLC was 100% on 375/398 (94.2%) of total treatments, while QNC was 88.9% on 341/398 (85.7%) total treatments. Patients scored 4.33/5.00 on privacy concerns, 4.00/5.00 on belief in benefits, 4.56/5.00 on satisfaction and 4.24/5.00 on usability via SUTAQ. 83.3% (15/18) of patients used the SBI on >50% of treatments. Patients in the intervention arm spent less time in clinic (53.24 ± 0.32 minutes) compared to the control (75.01 ± 2.26 minutes) group (p < 0.001). Similarly, the intervention arm spent less time on the linear accelerator (10.67 ± 0.41 minutes) compared to the control (14.19 ± 0.32 minutes) group (p < 0.001).
Conclusions:
This digital intervention trial showed high rates of bladder filling compliance and engagement. High patient-value and throughput efficiency was feasibly quantified by shortened clinic times and linac usage, respectively. Future studies are needed to evaluate clinical outcomes, patient experience and cost benefit. Clinical Trial: NCT04946214
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