A Behavioral Health Intervention Using Digital Technology in Radiation Therapy for Prostate Cancer Patients
NCT ID: NCT04946214
Last Updated: 2022-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
18 participants
INTERVENTIONAL
2021-05-26
2022-08-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Precise Oncology Interventions in Nutrition and Training (OnPoint)
NCT06534918
Technology Based Psychosocial Intervention for Symptom Management and HRQOL in Men Living With Advanced Prostate Cancer
NCT03149185
A Bio-psychosocial Sexual Health Intervention for Prostate Cancer Survivors and Partners: a Feasibility Study
NCT02640131
Caregivers' and Cancer Survivors' Psychological Distress & Symptom Management
NCT03743415
Behavioral Pain Intervention for Older Cancer Patients
NCT07300995
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
80 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Miami
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Alan Dal Pra
Associate Professor of Clinical Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alan Dal Pra, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Miami Lennar Medical Foundation
Miami, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20200017
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.