NCT04946214已完成不适用
A Pilot Study Using a Digital Behavioral Intervention With a Smart Water Bottle to Improve Bladder Filling Compliance in Prostate Cancer Patients Undergoing Radiation Therapy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Proportion of participants who did not continue to use the intervention through the study.
研究概览
简要总结
The purpose of this study is to determine how to incorporate a smart water bottle to improve bladder filling for prostate cancer patients undergoing radiation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age older than 17 but less than
- •Non-metastatic prostate cancer patients undergoing definitive radiation treatment.
- •Patients that self-identify as "smartphone owners".
- •Patients with either iPhone (iOS 13.0 or higher) or Android (version 5.0.1 or higher) based smartphone access.
- •English or Spanish speaking patients.
排除标准
- •Patients with any history of pre-existing urinary retention.
- •Patients with any history of kidney, urothelial tract or bladder cancer.
- •Post-operative prostate patients.
- •Patients that plan to be treated with pelvic lymph node radiation coverage.
- •Patients without a functional bladder.
- •Patients with a history of prior pelvic surgery or penile augmentation (circumcision is okay).
- •Patients who have previously received any form of pelvic radiation.
- •Patients unable to give informed consent.
- •Patients who refuse to drink room-temperature water used for bladder filling.
- •Patients without functional vision.
- •Patients who are colorblind.
- •Patient who refuse to use the smartphone app or who refuse consent.
研究组 & 干预措施
Smart Water Bottle Intervention Arm
Other
Patients will receive a smart water bottle, then instructed on bowel and bladder preparation for daily standard of care radiotherapy treatments for up to 10 weeks.
干预措施: Smart Water Bottle (Behavioral)
结局指标
主要结局
Proportion of participants who did not continue to use the intervention through the study.
时间窗: Up to 10 weeks
Proportion of participants will be reported as those who did not continue to use the intervention throughout the study.
次要结局
- Bladder volumetric measurements(Up to 10 weeks)
- Proportion of non-compliant participants as measured by bladder volume(Up to 10 weeks)
- Rectum Volumetric Measurements(Up to 10 weeks)
- Proportion of non-compliant participants as measured by survey(Up to 10 weeks)
- Proportion of patients refusing participation(Baseline)
- Patient's perception of bladder filling compliance as measured by Service User Technology Acceptability Questionnaire(Up to 10 weeks)
研究者
Alan Dal Pra
Associate Professor of Clinical Medicine
University of Miami
研究点 (1)
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