An observational study in Colorectal Cancer, Bladder Cancer and Ovarian Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center. Completed at 2 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by UNC Lineberger Comprehensive Cancer Center · Observational
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.
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.
255 studies on the registry are indexed under Uterine Neoplasms; 64 are open to participants now.
This study's enrollment of 13 is below the median of 220 across 64 observational studies indexed under Uterine Neoplasms.
Browse Uterine Neoplasms studies →UNC Lineberger Comprehensive Cancer Center is the lead sponsor of 414 studies on the registry; 96 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 25 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects receive treatment and their caregivers partners.
Phase I: The investigators will only be recruiting patients for this phase
Patients must:
Phase II: The investigators will be recruiting patients and caregivers as a dyad for this phase
Patients must:
Caregivers must:
Exclusion Criteria
Patients and their caregivers will be excluded if they:
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 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.
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.
Time frame: 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.
Time frame: 1-month followup survey
Plan to share: No — 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.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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UNC Lineberger Comprehensive Cancer Center