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Behavioral Intervention

AURA System for Post-Ostomy Care in Colorectal Cancer Patients (AURA Trial)

N/A
Waitlist Available
Led By Lixin Song, PhD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be able to read and speak English
Patients must be within one month of hospital discharge of a newly created ostomy with curative intent
Must not have
Patients and their caregivers will be excluded if they have other cancer diagnosis (excluding non-melanomatous skin cancer)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up t1 (baseline survey) and t2 (1-month followup survey)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new system to help cancer patients and caregivers during post-ostomy care transition.

Who is the study for?
This trial is for adult cancer patients who've had an ostomy for colorectal or bladder cancer, and their caregivers. Patients must be post-surgery by at least 90 days (Phase I) or within one month of discharge (Phase II). All participants need to read and speak English. Caregivers can't have cancer themselves.
What is being tested?
The AURA system is being tested to see if it helps with home care after an ostomy—a surgery creating an opening in the body for waste removal. The study will assess how easy the technology is to use and its effectiveness in supporting patient care.
What are the potential side effects?
Since AURA involves audio and radio systems rather than medications, traditional side effects are not expected. However, there may be privacy concerns or stress related to using new technology that will be monitored during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can read and speak English.
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I was discharged from the hospital within a month after getting an ostomy for treatment purposes.
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I am 18 years old or older.
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I had surgery for colorectal or bladder cancer aiming to cure it.
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I can read and speak English.
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I have had an ostomy for healing purposes for at least 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have no other cancer diagnosis except for non-melanoma skin cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~t1 (baseline survey) and t2 (1-month followup survey)
This trial's timeline: 3 weeks for screening, Varies for treatment, and t1 (baseline survey) and t2 (1-month followup survey) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Perceived ease of use of the PRISMS program
Satisfaction with the AURA system
Secondary study objectives
Change of Quality of Life (QOL)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AURAExperimental Treatment1 Intervention
In addition to usual care, participants assigned to this arm will have access to our Audio + Radio (AURA) system.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Audio + Radio (AURA)
2022
N/A
~20

Find a Location

Who is running the clinical trial?

U.S. National Science FoundationFED
34 Previous Clinical Trials
9,038 Total Patients Enrolled
National Library of Medicine (NLM)NIH
40 Previous Clinical Trials
107,664 Total Patients Enrolled
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
362 Previous Clinical Trials
91,973 Total Patients Enrolled

Media Library

Audio + Radio (AURA) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05344950 — N/A
Colorectal Cancer Research Study Groups: AURA
Colorectal Cancer Clinical Trial 2023: Audio + Radio (AURA) Highlights & Side Effects. Trial Name: NCT05344950 — N/A
Audio + Radio (AURA) (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05344950 — N/A
~4 spots leftby Nov 2025
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