Clinical trial NCT05344950: Connecting Audio and Radio Sensing Systems to Improve Care at Home
Official title: Development and Pilot Testing of AURA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Bladder Cancer
Ovarian Cancer
Cervical Cancer
Uterine Cancer
Keywords: ostomy (colostomy, urostomy, and ileostomy)
symptom
self-management
caregiving
family research
telehealth
self-efficacy
quality of life
post-treatment care transition
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: U.S. National Science Foundation
name: National Library of Medicine (NLM)
First posted: 2022-04-25
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects receive treatment and their caregivers partners.

Brief 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.

Detailed 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.

Eligibility 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).

Primary outcomes:
measure: Satisfaction with the AURA system
timeFrame: 1-month followup survey
measure: Perceived ease of use of the PRISMS program
timeFrame: 1-month followup survey
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: San Antonio
country: United States
facility: UT Health San Antonio MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Shahriar Nirjon, PhD
role: PRINCIPAL_INVESTIGATOR
References: