Colorectal CancerAURANCT05344950
Connecting Audio and Radio Sensing Systems to Improve Care at Home
An observational study of Colorectal Cancer and Bladder Cancer, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Colorectal Cancer, Bladder Cancer, Ovarian Cancer
- What is being tested?
- Audio + Radio (AURA)
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Mar 2022to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects receive treatment and their caregivers partners.
Who may be able to join
- 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;
Show all 18Show fewer
- 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).
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
UT Health San Antonio MD Anderson Cancer Center
San Antonio, Texas, 78229
About this study
Official title: Development and Pilot Testing of AURA
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.
Read the 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.
- Being tested
- Audio + Radio (AURA)
- Keywords
- ostomy (colostomy, urostomy, and ileostomy), symptom, self-management, caregiving, family research, telehealth, self-efficacy, quality of life, post-treatment care transition
- Medical subject headings
- Colorectal Neoplasms, Urinary Bladder Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio + Radio (AURA)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| AURA | In addition to usual care, participants assigned to this arm will have access to our Audio + Radio (AURA) system. Receives: Behavioral: Audio + Radio (AURA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1-month followup survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start21 Mar 2022
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. National Science Foundation, National Library of Medicine (NLM)
- Responsible party
- Sponsor
- Investigators
- Shahriar Nirjon, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344950
- Sponsor's protocol ID
- LCCC2123
- Acronym
- AURA
- Status last verified
- Sep 2024
- First submitted
- 19 Apr 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Testing of AURA
- ClinicalTrials.gov ID
- NCT05344950
- Acronym / sponsor ID
- AURA / LCCC2123
- Keywords
- ostomy (colostomy, urostomy, and ileostomy), symptom, self-management, caregiving, family research, telehealth, self-efficacy, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- U.S. National Science Foundation, National Library of Medicine (NLM)
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AURA | – | Behavioral: Audio + Radio (AURA)In addition to usual care, participants assigned to this arm will have access to our Audio + Radio (AURA) system. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects receive treatment and their caregivers partners.
Key inclusion criteria (18 listed)
- Phase I: The investigators will only be recruiting patients for this phase
- 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;
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | AURA |
Primary outcome
Satisfaction with the AURA system
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Clinical trials at UNC LinebergerLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahriar Nirjon, PhD principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Bladder Cancer, run by UNC Lineberger Comprehensive Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with the AURA system (time frame: 1-month followup survey). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.