Back to resultsA Behavioral Health Intervention Using Digital Technology in Radiation Therapy for Prostate Cancer Patients (HIDRATEPRO)
Primary Purpose
Prostate Cancer, Prostate Adenocarcinoma, Radiation Toxicity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Smart Water Bottle
Sponsored by
About this trial
This is an interventional supportive care trial for Prostate Cancer
Eligibility Criteria
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.
Sites / Locations
- University of Miami Lennar Medical Foundation
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Smart Water Bottle Intervention Arm
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Proportion of non-compliant participants as measured by survey
Proportion of non-compliant participants via a patient-reported survey.
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
Bladder volumetric measurements
As measured by cone beam CT scan
Rectum Volumetric Measurements
As measured by cone beam CT scan
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.
Proportion of patients refusing participation
Proportion of screen-eligible participants who refused study participation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04946214
Brief Title
A Behavioral Health Intervention Using Digital Technology in Radiation Therapy for Prostate Cancer Patients
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
May 26, 2021 (Actual)
Primary Completion Date
August 4, 2022 (Actual)
Study Completion Date
August 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Prostate Adenocarcinoma, Radiation Toxicity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Smart Water Bottle Intervention Arm
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Smart Water Bottle
Intervention Description
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 Outcome Measure Information:
Title
Proportion of participants who did not continue to use the intervention through the study.
Description
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 Outcome Measure Information:
Title
Proportion of non-compliant participants as measured by survey
Description
Proportion of non-compliant participants via a patient-reported survey.
Time Frame
Up to 10 weeks
Title
Proportion of non-compliant participants as measured by bladder volume
Description
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
Title
Bladder volumetric measurements
Description
As measured by cone beam CT scan
Time Frame
Up to 10 weeks
Title
Rectum Volumetric Measurements
Description
As measured by cone beam CT scan
Time Frame
Up to 10 weeks
Title
Patient's perception of bladder filling compliance as measured by Service User Technology Acceptability Questionnaire
Description
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
Title
Proportion of patients refusing participation
Description
Proportion of screen-eligible participants who refused study participation
Time Frame
Baseline
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Dal Pra, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Lennar Medical Foundation
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Behavioral Health Intervention Using Digital Technology in Radiation Therapy for Prostate Cancer Patients
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