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Completed

NCT Number: NCT04946214

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Adenocarcinoma Prostatic Diseases Prostatic Neoplasms Radiation Injuries Radiation Toxicity Urogenital Diseases Urogenital Neoplasms Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Lennar Medical Foundation

Miami, Florida, 33146, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Proportion of participants who did not continue to use the intervention through the study.

    Time frame: Up to 10 weeks

    Proportion of participants will be reported as those who did not continue to use the intervention throughout the study.

Secondary outcomes

  1. Proportion of non-compliant participants as measured by survey

    Time frame: Up to 10 weeks

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

  2. Proportion of non-compliant participants as measured by bladder volume

    Time frame: Up to 10 weeks

    Non-compliance to study intervention will be assessed using a cone beam Computerized Tomography (CT) scan of participant's bladder volume

  3. Bladder volumetric measurements

    Time frame: Up to 10 weeks

    As measured by cone beam CT scan

  4. Rectum Volumetric Measurements

    Time frame: Up to 10 weeks

    As measured by cone beam CT scan

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

    Time frame: Up to 10 weeks

    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.

  6. Proportion of patients refusing participation

    Time frame: Baseline

    Proportion of screen-eligible participants who refused study participation

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study 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

Acronym: HIDRATEPRO

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 30, 2021
Registry last updated
Sep 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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