ClinicalTrials.Veeva

Menu

Connecting Audio and Radio Sensing Systems to Improve Care at Home (AURA)

UNC Lineberger Comprehensive Cancer Center logo

UNC Lineberger Comprehensive Cancer Center

Status

Completed

Conditions

Uterine Cancer
Bladder Cancer
Ovarian Cancer
Cervical Cancer
Colorectal Cancer

Treatments

Behavioral: Audio + Radio (AURA)

Study type

Observational

Funder types

Other
Other U.S. Federal agency
NIH

Identifiers

NCT05344950
LCCC2123

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

13 participants in 1 patient group

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

Trial contacts and locations

2

Loading...

Central trial contact

Karl Shieh, MHS

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems