Department of Radiation Oncology, Jackson Memorial Hospital, Miami, FL, United States.
Department of Radiation Oncology, Sylvester Comprehensive Cancer Center, University of Miami Health Systems, Miami, FL, United States.
JMIR Cancer. 2024 Sep 10;10:e51061. doi: 10.2196/51061.
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).
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.
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.
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).
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.
ClinicalTrials.gov NCT04946214; https://www.clinicaltrials.gov/study/NCT04946214.
接受放射治疗（RT）的前列腺癌患者需要膀胱完全充盈，以减少治疗期间的毒性。由于标准护理的书面或口头指导的依从性较差，导致患者价值（PV）浪费和诊所资源利用率（TE）低下。
本文旨在评估基于智能手机的行为干预（SBI）改善膀胱充盈依从性的可行性和可接受性，并提出量化 PV 和 TE 的方法。
共招募了 36 名前列腺癌患者参与了这项单中心、封闭式、非随机可行性试验。SBI 由一个全自动智能水瓶和智能手机应用程序组成。两者都根据模拟膀胱容量，在患者计划接受 RT 前 1.25 小时，提醒患者排空膀胱并饮用个性化的水量目标。患者需要调整他们的水量目标和通知时间，以达到舒适的膀胱充盈。主要终点是定性（QLC）和定量（QNC）依从性均>80%。QLC 通过患者回答是否在每天的 RT 前准备好膀胱来评估。QNC 则是通过每日锥形束 CT 测量的膀胱容量达到模拟容量的>75%来评估。在 SBI 前后通过服务用户技术接受度问卷（SUTAQ）进行评估。如果 SUTAQ 的 4 个领域中有 3 个或更多领域>5/5，且>80%（15/18）的患者使用该设备的时间>50%，则认为患者的额外可接受性和参与性终点得到满足。最后，通过患者在诊所和直线加速器（linac）上花费的时间，分别衡量 SBI 对 PV 和 TE 的影响，并与匹配的对照组进行比较。
在 398 次总治疗中，QLC 为 100%的有 375 次（94.2%），而 QNC 为 88.9%的有 341 次（85.7%）。在总分 5 分中，患者在隐私问题上得分为 4.33，在相信益处上得分为 4，在满意度上得分为 4.56，在可用性上得分为 4.24，通过 SUTAQ 进行评估。此外，83%（15/18）的患者在>50%的治疗中使用了 SBI。干预组在诊所花费的时间（53.24，SEM 1.71 分钟）比对照组（75.01，SEM 2.26 分钟）少（P<.001）。同样，干预组在直线加速器上花费的时间（10.67，SEM 0.40 分钟）也比对照组（14.19，SEM 0.32 分钟）少（P<.001）。
本数字化干预试验显示出较高的膀胱充盈依从性和参与度。通过缩短诊所时间和直线加速器使用时间，分别实现了较高的患者价值和 TE 量化。需要进一步研究来评估临床结局、患者体验和成本效益。
ClinicalTrials.gov NCT04946214；https://www.clinicaltrials.gov/study/NCT04946214。
