Prostate CancerHIDRATEPRONCT04946214
A Behavioral Health Intervention Using Digital Technology in Radiation Therapy for Prostate Cancer Patients
A study testing Smart Water Bottle in people with Prostate Cancer and Prostate Adenocarcinoma, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer, Prostate Adenocarcinoma, Radiation Toxicity
- What is being tested?
- Smart Water Bottle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2021to 4 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Lennar Medical Foundation
Miami, Florida, 33146
About this study
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
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
- Being tested
- Smart Water Bottle
- Medical subject headings
- Prostatic Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Water BottleBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Smart Water Bottle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 10 weeks
Secondary outcomes (6)
Proportion of non-compliant participants as measured by survey
Proportion of non-compliant participants via a patient-reported survey.
Measured: 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
Measured: Up to 10 weeks
Bladder volumetric measurements
As measured by cone beam CT scan
Measured: Up to 10 weeks
Rectum Volumetric Measurements
As measured by cone beam CT scan
Measured: 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.
Measured: Up to 10 weeks
Proportion of patients refusing participation
Proportion of screen-eligible participants who refused study participation
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start26 May 2021
- Primary completion4 Aug 2022
- Study completion4 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Dal Pra, University of Miami
- Investigators
- Alan Dal Pra, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946214
- Sponsor's protocol ID
- 20200017
- Acronym
- HIDRATEPRO
- Status last verified
- Sep 2022
- First submitted
- 1 Jun 2021
- Last updated
- 30 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39255484
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04946214
- Acronym / sponsor ID
- HIDRATEPRO / 20200017
- Conditions
- Prostate Cancer, Prostate Adenocarcinoma, Radiation Toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 26 May 2021 (actual)
- Primary completion
- 4 Aug 2022 (actual)
- Study completion
- 4 Aug 2022 (actual)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smart Water Bottle Intervention Arm | Other | Behavioral: Smart Water BottlePatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart Water BottlePatients 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. | Behavioural | Smart Water Bottle Intervention Arm |
Primary outcome
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.
6 secondary outcomes
Proportion of non-compliant participants as measured by survey
Time frame: Up to 10 weeks
Proportion of non-compliant participants as measured by bladder volume
Time frame: Up to 10 weeks
Bladder volumetric measurements
Time frame: Up to 10 weeks
Rectum Volumetric Measurements
Time frame: Up to 10 weeks
Patient's perception of bladder filling compliance as measured by Service User Technology Acceptability Questionnaire
Time frame: Up to 10 weeks
Proportion of patients refusing participation
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- Derived from this study: PubMed 39255484Jin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Dal Pra, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Water Bottle in people with Prostate Cancer and Prostate Adenocarcinoma, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who did not continue to use the intervention through the study. (time frame: Up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04946214, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2022.