Bladder Cancer, Cervical Cancer, Colorectal Cancer, Ovarian Cancer, Uterine Cancer
Conditions
Keywords
ostomy (colostomy, urostomy, and ileostomy), symptom, self-management, caregiving, family research, telehealth, self-efficacy, quality of life, post-treatment care transition
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.
Interventions
BEHAVIORALAudio + Radio (AURA)
Participants will receive personalized self-care information based on their symptoms and signs of complications (e.g., fatigue) from interacting with our voice assistant device, connected to a system that integrating the patient-reported outcome and objective data from passive RF sensing to provide continuous monitoring of patients' symptoms and complications after they are discharged home.
Sponsors
U.S. National Science Foundation
National Library of Medicine (NLM)
UNC Lineberger Comprehensive Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with the AURA system | 1-month followup survey | 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. |
| Perceived ease of use of the PRISMS program | 1-month followup survey | 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. |
Countries
United States
Outcome results
None listed