A Smart Water Bottle and Companion App (HidrateSpark 3) to Improve Bladder-Filling Compliance in Patients With Prostate Cancer Receiving Radiotherapy: Nonrandomized Trial of Feasibility and Acceptability.

IF 3.3 Q2 ONCOLOGY JMIR Cancer Pub Date : 2024-09-10 DOI:10.2196/51061
William Jin, Christopher Montoya, Benjamin James Rich, Crystal Seldon Taswell, Miguel Noy, Deukwoo Kwon, Benjamin Spieler, Brandon Mahal, Matthew Abramowitz, Raphael Yechieli, Alan Pollack, Alan Dal Pra
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Abstract

Background: Patients with prostate cancer undergoing radiation therapy (RT) need comfortably full bladders to reduce toxicities during treatment. Poor compliance is common with standard of care written or 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: In total, 36 patients with prostate cancer were enrolled in a single-institution, closed-access, nonrandomized 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, based on simulation bladder volume, 1.25 hours before his scheduled RT. Patients were trained to adjust their volume goal and notification times to achieve comfortably full bladders. The primary end point was met if qualitative (QLC) and quantitative compliance (QNC) were >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 end points were met if >3 out of 5 across 4 domains on the SUTAQ and >80% (15/18) of patients used the device >50% of the time, respectively. Finally, the impact of SBI on PV and TE was measured by time spent in a clinic and on the linear accelerator (linac), respectively, and contrasted with matched controls.

Results: QLC was 100% in 375 out of 398 (94.2%) total treatments, while QNC was 88.9% in 341 out of 398 (85.7%) total treatments. Of a total score of 5, patients scored 4.33 on privacy concerns, 4 on belief in benefits, 4.56 on satisfaction, and 4.24 on usability via SUTAQ. Further, 83% (15/18) of patients used the SBI on >50% of treatments. Patients in the intervention arm spent less time in a clinic (53.24, SEM 1.71 minutes) compared to the control (75.01, SEM 2.26 minutes) group (P<.001). Similarly, the intervention arm spent less time on the linac (10.67, SEM 0.40 minutes) compared to the control (14.19, SEM 0.32 minutes) group (P<.001).

Conclusions: This digital intervention trial showed high rates of bladder-filling compliance and engagement. High patient value and TE were feasibly quantified by shortened clinic times and linac usage, respectively. Future studies are needed to evaluate clinical outcomes, patient experience, and cost-benefit.

Trial registration: ClinicalTrials.gov NCT04946214; https://www.clinicaltrials.gov/study/NCT04946214.

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智能水壶和配套应用程序(HidrateSpark 3)可提高接受放疗的前列腺癌患者膀胱充盈的依从性:关于可行性和可接受性的非随机试验。
背景:接受放射治疗(RT)的前列腺癌患者需要舒适饱满的膀胱,以减少治疗期间的毒性反应。目标:在此,我们评估了基于智能手机的行为干预(SBI)的可行性和可接受性,以改善膀胱充盈的依从性,以及量化膀胱充盈依从性和膀胱充盈效率的方法:共有 36 名前列腺癌患者参加了一项单一机构、封闭式、非随机的可行性试验。SBI 由全自动智能水瓶和智能手机应用程序组成。这两件设备都会提醒患者排空膀胱,并根据模拟膀胱容量在预定 RT 前 1.25 小时喝下个性化的目标水量。对患者进行了培训,以调整他们的水量目标和通知时间,从而实现舒适的膀胱充盈。如果定性依从性(QLC)和定量依从性(QNC)均大于 80%,则达到主要终点。就 QLC 而言,患者会被问及他们是否在每日 RT 前准备好了膀胱。如果每日锥束断层扫描显示的膀胱容积大于模拟容积的 75%,则符合 QNC 标准。服务用户技术可接受性问卷 (SUTAQ) 在 SBI 前后亲自发放。如果在 SUTAQ 的 4 个领域中 5 项中有 3 项以上,且有 80% 以上(15/18)的患者使用该设备的时间超过 50%,则分别达到了额外的可接受性和参与度终点。最后,SBI对PV和TE的影响分别通过在诊所和直线加速器(linac)上花费的时间来衡量,并与匹配对照组进行对比:在总共 398 次治疗中,375 次(94.2%)的 QLC 为 100%,而在总共 398 次治疗中,341 次(85.7%)的 QNC 为 88.9%。在总分 5 分中,患者通过 SUTAQ 对隐私问题的评分为 4.33 分,对益处的信心为 4 分,满意度为 4.56 分,可用性为 4.24 分。此外,83%(15/18)的患者在超过 50% 的治疗中使用了 SBI。与对照组(75.01 分钟,SEM 2.26 分钟)相比,干预组患者在门诊花费的时间更短(53.24 分钟,SEM 1.71 分钟):这项数字干预试验表明,膀胱充盈的依从性和参与度都很高。患者的高价值和 TE 可分别通过缩短的门诊时间和医用直流电来量化。未来的研究需要对临床结果、患者体验和成本效益进行评估:试验注册:ClinicalTrials.gov NCT04946214;https://www.clinicaltrials.gov/study/NCT04946214。
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来源期刊
JMIR Cancer
JMIR Cancer ONCOLOGY-
CiteScore
4.10
自引率
0.00%
发文量
64
审稿时长
12 weeks
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