Connecting Audio and Radio Sensing Systems to Improve Care at Home

Last updated: September 3, 2024
Sponsor: UNC Lineberger Comprehensive Cancer Center
Overall Status: Completed

Phase

N/A

Condition

Colorectal Cancer

Ovarian Cancer

Cervical Cancer

Treatment

Audio + Radio (AURA)

Clinical Study ID

NCT05344950
LCCC2123
  • Ages 18-99
  • All Genders

Study Summary

This study aims to assess the usability of the innovative Audio + Radio (AURA) system in enhancing personalized supportive care for cancer patients and caregivers during the post-ostomy care transition by collecting information on patient's daily activities and answers to survey questionnaire, and enabling access to this information through a voice assistant device.

Eligibility Criteria

Inclusion

Inclusion Criteria

Phase I: The investigators will only be recruiting patients for this phase

Patients must:

  • have been surgically treated for colorectal or bladder cancer with curative intent;

  • have had an ostomy with curative intent for at least 90 days;

  • be able to read and speak English;

  • be 18 years or older;

Phase II: The investigators will be recruiting patients and caregivers as a dyad for this phase

  • Patients must:

  • have been surgically treated for colorectal or bladder cancer with curative intent;

  • be within one month of hospital discharge of a newly created ostomy with curative intent;

  • be able to read and speak English;

  • be 18 years or older;

  • have a caregiver who is willing to participate in the study;

  • Caregivers must:

  • be 18 years or older;

  • be able to read and speak English;

  • be identified as the primary caregiver by the patient;

  • have not themselves been diagnosed with cancer or received cancer treatment during the study (to ensure that patients and caregivers focus their efforts on care of the patient).

Exclusion Criteria

Patients and their caregivers will be excluded if they:

  • are unable to read, speak, or understand English;

  • have more than one type of ostomy;

  • have other cancer diagnosis (excluding non-melanomatous skin cancer); or

  • have cognitive impairment (assessed by the Short Portable Mental Status Questionnaire).

Study Design

Total Participants: 13
Treatment Group(s): 1
Primary Treatment: Audio + Radio (AURA)
Phase:
Study Start date:
March 21, 2022
Estimated Completion Date:
July 31, 2024

Study Description

The investigators will assign up to 30 cancer patients with newly created ostomies for cancer treatment with curative intent and their primary caregivers to the AURA or usual care groups (up to 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. Additionally, the system enables user's access to this information through a voice assistant device. 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. 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.

Connect with a study center

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • UT Health San Antonio MD Anderson Cancer Center

    San Antonio, Texas 78229
    United States

    Site Not Available

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