Image

Connecting Audio and Radio Sensing Systems to Improve Care at Home

Recruiting
18 - 99 years of age
Both
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

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 details

Colorectal Cancer, Bladder Cancer, Ovarian Cancer, Cervical Cancer, Uterine Cancer

NCT05344950

UNC Lineberger Comprehensive Cancer Center

9 June 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.