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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart Water Bottle | Behavioral | Patients will be given a smart water bottle and coached on its use. The device is a 24 oz non-bisphenol A acrylic water bottle with the ability to track water consumption from the bottle, alert its users via a smartphone-based notification system, as well as visually remind patients with a light-emitting diode in the device. Participants will be alerted to drink patient-specific volumes of room temperature water 45 minutes prior to daily standard of care radiotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who did not continue to use the intervention through the study. | Proportion of participants will be reported as those who did not continue to use the intervention throughout the study. | Up to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of non-compliant participants as measured by survey | Proportion of non-compliant participants via a patient-reported survey. | Up to 10 weeks |
| Proportion of non-compliant participants as measured by bladder volume |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Dal Pra, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Lennar Medical Foundation | Miami | Florida | 33146 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39255484 | Derived | Jin W, Montoya C, Rich BJ, Taswell CS, Noy M, Kwon D, Spieler B, Mahal B, Abramowitz M, Yechieli R, Pollack A, Dal Pra A. 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. JMIR Cancer. 2024 Sep 10;10:e51061. doi: 10.2196/51061. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Non-compliance to study intervention will be assessed using a cone beam Computerized Tomography (CT) scan of participant's bladder volume
| Up to 10 weeks |
| Bladder volumetric measurements | As measured by cone beam CT scan | Up to 10 weeks |
| Rectum Volumetric Measurements | As measured by cone beam CT scan | Up to 10 weeks |
| Patient's perception of bladder filling compliance as measured by Service User Technology Acceptability Questionnaire | Patient reported scores based on Service User Technology Acceptability Questionnaire (SUTAQ) will measure patient's perception of the smart water bottle. SUTAQ has a total score ranging from 20-100 with the higher score indicating increased user acceptability and comfort with the device. | Up to 10 weeks |
| Proportion of patients refusing participation | Proportion of screen-eligible participants who refused study participation | Baseline |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014947 | Wounds and Injuries |