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

Development and Pilot Testing of AURA

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer; Colorectal Cancer; Ovarian Cancer; Bladder Cancer; Uterine Cancer
• Intervention / Treatment: Behavioral: Audio + Radio (AURA)

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. The investigators 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 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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karl Shieh, MHS; Phone Number: 919-966-3119; Email: kshieh12@email.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina at Chapel Hill
      • Contact: Shahriar Nirjon, PhD; Phone Number: 919-966-3612; Email: nirjon@cs.unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AURA; In addition to usual care, participants assigned to this arm will have access to our Audio + Radio (AURA) system.	Behavioral: Audio + Radio (AURA); Participants will receive personalized self-care information and guidance based on their symptoms and signs of complications (e.g., skin infection, fatigue) from interacting with our voice assistant device, connected to a system that integrating the PRO (e.g., fatigue) and objective data from passive RF sensing to provide continuous monitoring of patients' symptoms and complications after they are discharged home. AURA will triage patient care based on the monitoring data that indicate the severity of their symptoms and complications. Patients and caregivers will self-monitor and manage at home for mild and moderate symptoms but be referred to professionals (e.g., wound and stoma nurse) when the patient experiences severe symptoms or significantly worsened symptoms.
No Intervention: Usual Care; Participants assigned to this arm will receive the standard of care that is provided to all patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment rate	Enrollment rate will be assessed by the percentage of potentially eligible participants who have completed the baseline survey.	after T1 (baseline survey)
Recruitment Rate	Recruitment rate will be assessed by the percentage of potentially eligible participants who have consented to participate in the study	from study launching to ending, about 1 year
Retention rate	Retention rate will be assessed by the percentage of enrolled participants who have completed the 30-day followup survey at the end of the study period.	after T2 (1-month followup survey)
Satisfaction with the AURA system	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.	after T2 (1-month followup survey)
Perceived ease of use of the PRISMS program	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.	after T2 (1-month followup survey)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Quality of Life (QOL)	Quality of Life (QoL) will be assessed using the Functional Assessment of Cancer Therapy General Scale (FACT-G) v.4, a 27-item measure yielding total score and scores for physical, social/family, emotional, and functional well-being of demonstrated reliability, validity, and sensitivity to change. FACT-G consists of 4 subscales: physical well-being (PWB), functional well-being (FWB), emotional well-being (EWB) and social well-being (SWB). Scores on the four subscales are summed to produce a total score ranging from 0 to 108 with higher scores indicating better quality of life. Change in the FACT-G scores from T1 (baseline survey) to T2 (2-month followup survey) will be calculated.	T1 (baseline survey) and T2 (1-month followup survey)

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: National Library of Medicine (NLM); U.S. National Science Foundation
• Investigators: Principal Investigator: Shahriar Nirjon, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: quality of life; self-management; caregiving; self-efficacy; telehealth; symptom; family research; ostomy (colostomy, urostomy, and ileostomy); post-treatment care transition
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Neoplasms
• Other Study ID Numbers: LCCC2123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot study with very small sample size and specific inclusion criteria. Sharing data with others may increase the risk to patient confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No