Prostate Adenocarcinoma, Prostate Cancer, Radiation Toxicity
Conditions
Brief summary
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.
Interventions
BEHAVIORALSmart Water Bottle
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.
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age older than 17 but less than 81. * 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who did not continue to use the intervention through the study. | Up to 10 weeks | Proportion of participants will be reported as those who did not continue to use the intervention throughout the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of non-compliant participants as measured by bladder volume | Up to 10 weeks | Non-compliance to study intervention will be assessed using a cone beam Computerized Tomography (CT) scan of participant's bladder volume |
| Bladder volumetric measurements | Up to 10 weeks | As measured by cone beam CT scan |
| Proportion of non-compliant participants as measured by survey | Up to 10 weeks | Proportion of non-compliant participants via a patient-reported survey. |
| Patient's perception of bladder filling compliance as measured by Service User Technology Acceptability Questionnaire | Up to 10 weeks | 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. |
| Proportion of patients refusing participation | Baseline | Proportion of screen-eligible participants who refused study participation |
| Rectum Volumetric Measurements | Up to 10 weeks | As measured by cone beam CT scan |
Countries
United States
Outcome results
None listed