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Brief Title: Connecting Audio and Radio Sensing Systems to Improve Care at Home

Development and Pilot Testing of AURA

INTRODUCTION

  • Org Study ID: LCCC2123
  • Secondary ID: N/A
  • NTC ID: NCT05344950
  • Sponsor: UNC Lineberger Comprehensive Cancer Center

BRIEF SUMMARY

This is a proof-of-concept pilot randomized clinical trial to test the usability and feasibility of the innovative Audio + Radio (AURA) system to enhance personalized supportive care for cancer patients and caregivers during post-ostomy care transition.

DETAILED DESCRIPTION

In this proof-of-concept study, our multidisciplinary team will conduct a pilot randomized clinical trial to test the feasibility of the innovative AUdio + RAdio (AURA) system to enhance personalized supportive care for cancer patients and caregivers during post-treatment care transition. We will randomly 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 user 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. We 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, we 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.

  • Overall Status
    Recruiting
  • Start Date
    March 21, 2022
  • Phase
    Not Applicable
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Recruitment Rate

Primary Outcome 1 - Timeframe: from study launching to ending, about 1 year

Primary Outcome 2 - Measure: Enrollment rate

Primary Outcome 2 - Timeframe: after T1 (baseline survey)

Primary Outcome 3 - Measure: Retention rate

Primary Outcome 3 - Timeframe: after T2 (1-month followup survey)

Primary Outcome 4 - Measure: Satisfaction with the AURA system

Primary Outcome 4 - Timeframe: after T2 (1-month followup survey)

Primary Outcome 5 - Measure: Perceived ease of use of the PRISMS program

Primary Outcome 5 - Timeframe: after T2 (1-month followup survey)

CONDITION

  • Colorectal Cancer
  • Bladder Cancer
  • Ovarian Cancer
  • Cervical Cancer
  • Uterine Cancer

ELIGIBILITY

Inclusion Criteria
Phase I: We 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: We 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).

Gender: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Lixin Song, PhD

Role: Principal Investigator

Affiliation: University of North Carolina, Chapel Hill

Overall Contact

Name: Lixin Song, PhD

Phone: 919-966-3119

Email: kshieh12@email.unc.edu

LOCATION

Facility Status Contact
Facility: University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United States
Status: Recruiting Contact: Contact
Lixin Song, PhD
919-966-3612
lsong@unc.edu