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

Prostate Cancer Clinical Trial

— HIDRATEPRO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04946214
• Other study ID #: 20200017
• Status: Completed
• Phase: N/A
• Start date: May 26, 2021
• Est. completion date: August 4, 2022

Study information

• Verified date: September 2022
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 4, 2022
• Est. primary completion date: August 4, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms
• Radiation Toxicity

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami Lennar Medical Foundation	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of non-compliant participants as measured by survey	Proportion of non-compliant participants via a patient-reported survey.	Up to 10 weeks
Secondary	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
Secondary	Bladder volumetric measurements	As measured by cone beam CT scan	Up to 10 weeks
Secondary	Rectum Volumetric Measurements	As measured by cone beam CT scan	Up to 10 weeks
Secondary	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
Secondary	Proportion of patients refusing participation	Proportion of screen-eligible participants who refused study participation	Baseline