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Behavioral Intervention

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

N/A
Recruiting
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
Caregivers must be 18 years or older
Patients must be able to read and speak English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study launching to ending, about 1 year
Awards & highlights

AURA Trial 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.Check my eligibility
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.See study design
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.

AURA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 18 years old.
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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, as a caregiver, have not been diagnosed with or treated for cancer during this study.
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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 can read and speak English.
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I am 18 years old or older.
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I have had an ostomy for healing purposes for at least 3 months.
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I had surgery for colorectal or bladder cancer aiming for a cure.

AURA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study launching to ending, about 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and from study launching to ending, about 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Enrollment rate
Perceived ease of use of the PRISMS program
Recruitment Rate
+2 more
Secondary outcome measures
Change of Quality of Life (QOL)

AURA Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AURAExperimental Treatment1 Intervention
In addition to usual care, participants assigned to this arm will have access to our Audio + Radio (AURA) system.
Group II: Usual CareActive Control1 Intervention
Participants assigned to this arm will receive the standard of care that is provided to all patients.

Find a Location

Who is running the clinical trial?

National Library of Medicine (NLM)NIH
39 Previous Clinical Trials
107,423 Total Patients Enrolled
U.S. National Science FoundationFED
34 Previous Clinical Trials
8,814 Total Patients Enrolled
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
348 Previous Clinical Trials
88,111 Total Patients Enrolled
4 Trials studying Ovarian Cancer
191 Patients Enrolled for Ovarian Cancer

Media Library

Audio + Radio (AURA) (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05344950 — N/A
Ovarian Cancer Research Study Groups: AURA, Usual Care
Ovarian 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would qualify to participate in this trial?

"This clinical trial seeks 60 individuals aged 18-99 who have recently been operated on for ovarian cancer. Other prerequisites include: having previously underwent surgery with curative intent to treat colorectal or bladder cancer;, being fluent in the English language;, and within one month of hospital discharge after ostomy creation that is intended to be curative. Furthermore, any potential participant must not possess a personal history of malignancy nor had received treatment for it during the experiment's duration (to make certain both patient and attendant would primarily focus on care). For Phase I only patients will be recruited while both parties are needed for Phase II -"

Answered by AI

Is this research open to participants aged 50 and up?

"The trial is looking for applicants aged 18 to 99, however there are 54 studies offered to pediatric patients and 1307 targeted towards seniors."

Answered by AI

Are applications for the trial still being accepted from potential participants?

"Affirmative, the records on clinicaltrials.gov make evident that this medical trial is actively seeking volunteers. The project was launched on March 21st 2022 and its most recent amendment occurred on May 24th 2022. There are a total of 60 individuals needed to be enrolled from 1 distinct site."

Answered by AI

How many individuals is the trial recruiting?

"Correct. The clinical trial's page on clinicaltrials.gov affirms that the study is recruiting participants; it was first published in March of 2022 and last updated at the end of May later that year. Sixty individuals need to be enrolled across a single site for this research project to proceed.."

Answered by AI
~0 spots leftby Apr 2024