A Behavioral Health Intervention Using Digital Technology in Radiation Therapy for Prostate Cancer Patients

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Prostate Cancer, Prostate Adenocarcinoma, Radiation Toxicity

Intervention / Treatment
-----------------
* Behavioral: Smart Water Bottle


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Smart Water Bottle Intervention Arm<br>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. | Behavioral: Smart Water Bottle<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |