This clinical trial tests the audio and radio (AURA) system to improve the transition from hospital care to self-care in the home following ostomy surgery for patients with bladder and colorectal cancer and their caregivers. AURA is a software program that analyzes wireless fidelity (Wi-Fi) signals to detect human movement, classify activities, and listen and respond to participants using an Amazon Echo device. Participants will be testing the AURA system’s accuracy by interacting daily with the system and being recorded by video cameras as a basis for comparison to see if AURA has correctly identified any symptoms. The use of the AURA system by patients and their caregivers may help improve cancer symptom and complication management, as well as better quality of life when living with a newly created ostomy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05344950.
PRIMARY OBJECTIVES:
I. To test the usability of AURA. (Phase I).
II. To examine the feasibility of delivering AURA to patients and caregivers (as assessed by the recruitment, enrollment, and retention rates, and satisfaction with and perceived ease of use of AURA). (Phase II).
SECONDARY OBJECTIVE:
I. To estimate the magnitude of benefit of AURA (system, website, monitoring, and personalized self-care instruction).
OUTLINE: This is a phase I study followed by a randomized phase II study.
PHASE I: Participants use the voice assistant on the AURA system in conjunction with Amazon Echo, Fitbit synchronization, and video camera at an in-person home visit for 4 weeks. Patients also receive usual care that is available clinically. Participants receive telephone, email, and/or text message reminders to use the program.
PHASE II: Participant are randomized to 1 of 2 arms.
ARM A: Participants use the voice assistant with radiofrequency detection on the AURA system in conjunction with Amazon Echo and Fitbit synchronization at home for 30 days. Education, support, and resources, as well as personalized feedback and triage care provided through AURA prompting. Participants receive telephone, email, and/or text message reminders to use the program.
ARM B: Participants use a version of the voice assistant program that only utilizes the voice commands and web interface for education, support, and resources. for 30 days.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorShahriar Nirjon