Connecting Audio and Radio Sensing Systems to Improve Care at Home

Recruiting

• Conditions: Ovarian Cancer; Colorectal Cancer; Uterine Cancer; Cervical Cancer; Bladder Cancer
• Interventions: Behavioral: Audio + Radio (AURA)

• Registration Number: NCT05344950
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief 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.

Detailed 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 Timeline

• Study Start: 2022-03-21
• Study First Submitted: 2022-04-19
• Study First Submitted QC: 2022-04-19
• Study First Posted: 2022-04-25
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-05
• Primary Completion: 2025-04-30
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AURA	Audio + Radio (AURA)	In addition to usual care, participants assigned to this arm will have access to our Audio + Radio (AURA) system.

Primary Outcome Measures

Name	Time	Method
Satisfaction with the AURA system	1-month followup survey	Satisfaction with the AURA system will be assessed by the 9-item Participant Satisfaction Scale measuring the level of program satisfaction ranging from 1=not satisfied to 5=extremely satisfied. Higher total score indicates greater program satisfaction.
Perceived ease of use of the PRISMS program	1-month followup survey	Perceived ease of use of the AURA system will be assessed by the 23-item Usability Scale measuring the ease of use in three aspects: general, content, and navigation. The scales range from 1=strongly disagree to 5=strongly agree. Higher total score indicates greater ease of use.

Trial Locations

Locations (2)

UT Health San Antonio MD Anderson Cancer Center; 🇺🇸 San Antonio, Texas, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States