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

• Sponsor: University of Miami (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04946214
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 16.2
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Prostate Adenocarcinoma; Radiation Toxicity	Behavioral: Smart Water Bottle	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: May 26, 2021
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm

Intervention/Treatment

Other: Smart Water Bottle Intervention Arm 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; 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.

Outcome Measures

Primary Outcome Measures

1. Proportion of participants who did not continue to use the intervention through the study. [Up to 10 weeks]

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

Secondary Outcome Measures

1. Proportion of non-compliant participants as measured by survey [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 [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 [Up to 10 weeks]

   As measured by cone beam CT scan

4. Rectum Volumetric Measurements [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 [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 [Baseline]

   Proportion of screen-eligible participants who refused study participation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami Lennar Medical Foundation	Miami	Florida	United States	33146

Sponsors and Collaborators

• University of Miami

Investigators

• Principal Investigator: Alan Dal Pra, MD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alan Dal Pra, Associate Professor of Clinical Medicine, University of Miami
• ClinicalTrials.gov Identifier: NCT04946214
• Other Study ID Numbers: 20200017
• First Posted: Jun 30, 2021
• Last Update Posted: May 12, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms

Study Results

No Results Posted as of May 12, 2022