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Clinical Trial Summary

This study aims to assess the usability and feasibility of the innovative Audio + Radio (AURA) system in enhancing personalized supportive care for cancer patients and caregivers during the post-ostomy care transition.


Clinical Trial Description

The investigators will assign 30 cancer patients with newly created ostomies for cancer treatment with curative intent and their primary caregivers to the AURA or usual care groups (30 patient-caregiver dyads, a total of 60 individuals). AURA is defined as a system that connects audio-based voice assistant devices with radiofrequency (RF) sensing technology to gather relevant patient information automatically, interactively, and with context-awareness and to store a patient's health records that otherwise had to be measured and entered manually into an electronic system. The users of this system will be the entire care team, consisting of the patient and their family members as well as the caregivers and healthcare providers at remote sites. The investigators will conduct pre- and post-assessments of quality of life (QOL) and patient-reported outcomes (PRO, symptoms) at baseline upon enrollment and 2 months later. If results indicate that the pilot trial is feasible, the investigators will design and conduct a definitive trial to examine the efficacy of AURA, a potentially scalable intervention that can be disseminated through oncology clinics nationwide to enhance post-treatment care for cancer patients with ostomies who transition from hospital professional care to self-management at home and their caregivers. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05344950
Study type Observational
Source UNC Lineberger Comprehensive Cancer Center
Contact Karl Shieh, MHS
Phone 919-966-3119
Email kshieh12@email.unc.edu
Status Recruiting
Phase
Start date March 21, 2022
Completion date July 2025

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