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

NCT04946214 | Completed

• 1 other identifier: 20200017
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Prostate Adenocarcinoma; Radiation Toxicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Proportion of non-compliant participants as measured by survey

  Up to 10 weeks

• Proportion of non-compliant participants as measured by bladder volume

  Up to 10 weeks

• Bladder volumetric measurements

  Up to 10 weeks

• Rectum Volumetric Measurements

  Up to 10 weeks

• Patient's perception of bladder filling compliance as measured by Service User Technology Acceptability Questionnaire

  Up to 10 weeks

Study Arms (1)

Smart Water Bottle Intervention Arm

OTHER

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

Interventions

Smart Water Bottle BEHAVIORAL

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.

Smart Water Bottle Intervention Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Lennar Medical Foundation

Miami, Florida, 33146, United States

Location

Related Publications (1)

• Jin W, Montoya C, Rich BJ, Taswell CS, Noy M, Kwon D, Spieler B, Mahal B, Abramowitz M, Yechieli R, Pollack A, Dal Pra A. A Smart Water Bottle and Companion App (HidrateSpark 3) to Improve Bladder-Filling Compliance in Patients With Prostate Cancer Receiving Radiotherapy: Nonrandomized Trial of Feasibility and Acceptability. JMIR Cancer. 2024 Sep 10;10:e51061. doi: 10.2196/51061.

  PMID: 39255484 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Radiation Injuries

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Wounds and Injuries

Study Officials

• Alan Dal Pra, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Medicine

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 30, 2021
• Study Start: May 26, 2021
• Primary Completion: August 4, 2022
• Study Completion: August 4, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)