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

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

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 Overview

• Status: Completed
• Conditions: Prostate Cancer; Prostate Adenocarcinoma; Radiation Toxicity
• Intervention / Treatment: Behavioral: Smart Water Bottle

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33146
      • University of Miami Lennar Medical Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Smart Water Bottle Intervention Arm; 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; 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.

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

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Alan Dal Pra, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2021
• Primary Completion (Actual): August 4, 2022
• Study Completion (Actual): August 4, 2022

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 20200017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No