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

University of Miami

Status: Completed

Conditions: Radiation Toxicity; Prostate Adenocarcinoma; Prostate Cancer

Treatments: Behavioral: Smart Water Bottle

Study type: Interventional

Funder types: Other

Identifiers

NCT04946214

20200017

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Smart Water Bottle Intervention Arm

Other group

Description:

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.

Treatment:

Behavioral: Smart Water Bottle