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

Not Applicable

Completed

• Conditions: Prostate Adenocarcinoma; Prostate Cancer; Radiation Toxicity
• Interventions: Behavioral: Smart Water Bottle

• Registration Number: NCT04946214
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-26
• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-30
• Primary Completion: 2022-08-04
• Study Completion: 2022-08-04
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Smart Water Bottle Intervention Arm	Smart Water Bottle	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Bladder volumetric measurements	Up to 10 weeks	As measured by cone beam CT scan
Rectum Volumetric Measurements	Up to 10 weeks	As measured by cone beam CT scan
Proportion of non-compliant participants as measured by survey	Up to 10 weeks	Proportion of non-compliant participants via a patient-reported survey.
Proportion of patients refusing participation	Baseline	Proportion of screen-eligible participants who refused study participation
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.

Trial Locations

Locations (1)

University of Miami Lennar Medical Foundation; 🇺🇸 Miami, Florida, United States