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

University of Miami18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Prostate Cancer Prostate Adenocarcinoma Radiation Toxicity

Interventions

Smart Water BottleBEHAVIORAL

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.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Miami Lennar Medical Foundation

Miami, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 10 weeks

Secondary Outcomes

Proportion of non-compliant participants as measured by survey

Proportion of non-compliant participants via a patient-reported survey.

Time frame: 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

Time frame: Up to 10 weeks

Bladder volumetric measurements

As measured by cone beam CT scan

Time frame: Up to 10 weeks

Rectum Volumetric Measurements

As measured by cone beam CT scan

Time frame: 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.

Time frame: Up to 10 weeks

Proportion of patients refusing participation

Proportion of screen-eligible participants who refused study participation

Data from ClinicalTrials.gov

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