This clinical trial assesses the use of a smart water bottle to improve bladder filling for prostate cancer patients undergoing radiation therapy. A consistent bladder filling throughout the treatment is important to help improve the quality of cancer treatment. When patients do not have a full bladder during radiation treatments, they may be asked to fill their bladder, which can lead to treatment delays and back up the clinic’s flow. A digital smartphone-based behavioral intervention may coach motivated prostate cancer patients to develop a sensory awareness of an optimally filled bladder, improving their need for re-imaging while on the radiation treatment table and decreasing their overall time in clinic. This study may also help researchers learn more about how to reduce wasted time in the radiation clinic.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04946214.
PRIMARY OBJECTIVE:
I. Determine feasibility in adoption of a digital health intervention for bladder volume compliance.
SECONDARY OBJECTIVES:
I. Determine feasibility in adoption of a digital health intervention for bladder volume compliance based on patients’ survey.
II. Determine feasibility in adoption of a digital health intervention for bladder volume compliance based on cone-beam computed tomography (CT).
III. Identify barriers for implementation of qualitative and quantitative metrics of bladder filling compliance.
IV. Assess patient’s perception of bladder filling compliance.
V. Assess patient attitudes towards digital health behavioral interventions.
VI. Assess screen failure rate.
OUTLINE:
Patients receive a Hidrate Spark 3 smart water bottle, and receive visual cues on the water bottle and reminders via the "Hidrate" application (app) to drink 20 oz of room temperature water 45 minutes prior to their CT simulation. Patients then receive reminders to drink 20 oz of room temperature water 45 minutes prior to their scheduled daily radiation treatments 5 days per week and undergo cone beam CT prior to their treatments.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Miami Miller School of Medicine-Sylvester Cancer Center
Principal InvestigatorAlan Libardi Dal Pra