Cognitive BurdenNCT06026098
Evaluation of Impact of AI Assistance on Workload Associated w Preparation of Rare Tumor Case Repts
A study testing Artificial Intelligence in people with Cognitive Burden and Cognitive Symptom, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
The goal of this study is to explore cognitive burden perceptions among physicians in relation to case report writing. Furthermore, this study evaluates the use of artificial intelligence (AI) assistance as a tool to reduce cognitive burden among providers preparing and submitting case reports. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Burden, Cognitive Symptom
- What is being tested?
- Artificial Intelligence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. The subject is a physician, medical student, or postdoctoral student.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514
Shivani Sud, 984-987-1072, shivani.sud@unchealth.unc.edu
Victoria Xu, 984-974-8744, victoria_xu@med.unc.edu
About this study
Official title: A Prospective Evaluation of Impact of AI Assistance on Workload Associated With Preparation of Rare Tumor Case Reports
The goal of this study is to explore cognitive burden perceptions among physicians in relation to case report writing. Furthermore, this study evaluates the use of artificial intelligence (AI) assistance as a tool to reduce cognitive burden among providers preparing and submitting case reports. If an AI-tool is helpful in this setting, it may potentially help increase reporting of rare medical events and thereby improve the evidence base for care of these patient populations. This study will occur at a single time point which is expected to last approximately 2 hours. This session will include reviewing two rare tumor cases and then writing a clinical vignette with and without AI assistance.
- Conditions
- Cognitive Burden, Cognitive Symptom
- Being tested
- Artificial Intelligence
- Keywords
- artificial intelligence, case report
- Medical subject headings
- Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial IntelligenceBehavioural
Participants will use the Artificial Intelligence assistance tool for case reports.
| Study group | Role | What they receive |
|---|---|---|
| Case Report with Artificial Intelligence | Experimental | Medical students, resident physicians, or attending physicians report rare cases with using Artificial Intelligence. Receives: Behavioral: Artificial Intelligence |
| Case Report without Artificial Intelligence | No intervention | Medical students, resident physicians, or attending physicians report rare cases without using Artificial Intelligence. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Cognitive workload (CWL)
Subjective Cognitive workload (CWL) will be measured while interviews using The National Aeronautics and Space Administration task load (NASA TLX) index is a tool for measuring and conducting a subjective mental workload (MWL) assessment.
The NASA-TLX is a subjective measure of CWL and is used across many disciplines. The NASA-TLX considers six dimensions-Mental, Physical, and Temporal Demands, Frustration, Effort, and Performance. NASA-TLX scores ≥55 have been associated with reduced performance in numerous settings. NASA-TLX is considered to be the most used subjective measure of CWL. The validated two-stage process with participants performing 15 separate pair-wise comparisons between 6 dimensions of NASA-TLX will be used. A workload score will be marked from low and high for each dimension.
Score values from 0 -100. The Interpretation Score of NASA TLX for Low 0-9, Medium 10-29, Somewhat high 30-49, High 50-79, and Very high 80-100
Measured: Baseline to 2 hours
Perceived cognitive load
The perceived cognitive load will be measured using System Usability Scale (SUS).
SUS is a validated post-test questionnaire that measures user satisfaction. Further, studies confirm that SUS is predictive of the impacts of changes to the user interface on usability when multiple changes to a single product were made over a large number of iterations.
SUS is composed of 10 questions- five positive and five negative statements, each having a five-point scale that ranges from strongly disagree to strongly agree. SUS provides a score (range, 0-100) based on the participant's rating of 10 statements regarding usability with higher scores indicating greater satisfaction with usability.
Measured: Baseline to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study startOct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive BurdenStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shivani Sud, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026098
- Sponsor's protocol ID
- 23-1262
- Status last verified
- Sep 2026
- First submitted
- 29 Aug 2023
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of Impact of AI Assistance on Workload Associated With Preparation of Rare Tumor Case Reports
- ClinicalTrials.gov ID
- NCT06026098
- Acronym / sponsor ID
- 23-1262
- Conditions
- Cognitive Burden, Cognitive Symptom
- Keywords
- artificial intelligence, case report
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Sep 2023 (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.
The goal of this study is to explore cognitive burden perceptions among physicians in relation to case report writing. Furthermore, this study evaluates the use of artificial intelligence (AI) assistance as a tool to reduce cognitive burden among providers preparing and submitting case reports. If an AI-tool is helpful in this setting, it may potentially help increase reporting of rare medical events and thereby improve the evidence base for care of these patient populations. This study will occur at a single time point which is expected to last approximately 2 hours. This session will include reviewing two rare tumor cases and then writing a clinical vignette with and without AI assistance.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Report with Artificial Intelligence | Experimental | Behavioral: Artificial IntelligenceMedical students, resident physicians, or attending physicians report rare cases with using Artificial Intelligence. |
| Case Report without Artificial Intelligence | No intervention | –Medical students, resident physicians, or attending physicians report rare cases without using Artificial Intelligence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. The subject is a physician, medical student, or postdoctoral student.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Artificial IntelligenceParticipants will use the Artificial Intelligence assistance tool for case reports. | Behavioural | Case Report with Artificial Intelligence |
Primary outcome
Subjective Cognitive workload (CWL)
Time frame: Baseline to 2 hours
Subjective Cognitive workload (CWL) will be measured while interviews using The National Aeronautics and Space Administration task load (NASA TLX) index is a tool for measuring and conducting a subjective mental workload (MWL) assessment. The NASA-TLX is a subjective measure of CWL and is used across many disciplines. The NASA-TLX considers six dimensions-Mental, Physical, and Temporal Demands, Frustration, Effort, and Performance. NASA-TLX scores ≥55 have been associated with reduced performance in numerous settings. NASA-TLX is considered to be the most used subjective measure of CWL. The validated two-stage process with participants performing 15 separate pair-wise comparisons between 6 dimensions of NASA-TLX will be used. A workload score will be marked from low and high for each dimension. Score values from 0 -100. The Interpretation Score of NASA TLX for Low 0-9, Medium 10-29, Somewhat high 30-49, High 50-79, and Very high 80-100
Perceived cognitive load
Time frame: Baseline to 2 hours
The perceived cognitive load will be measured using System Usability Scale (SUS). SUS is a validated post-test questionnaire that measures user satisfaction. Further, studies confirm that SUS is predictive of the impacts of changes to the user interface on usability when multiple changes to a single product were made over a large number of iterations. SUS is composed of 10 questions- five positive and five negative statements, each having a five-point scale that ranges from strongly disagree to strongly agree. SUS provides a score (range, 0-100) based on the participant's rating of 10 statements regarding usability with higher scores indicating greater satisfaction with usability.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Shivani Sud principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence in people with Cognitive Burden and Cognitive Symptom, run by UNC Lineberger Comprehensive Cancer Center at 1 site 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 1 inclusion and 0 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: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shivani Sud (984-987-1072, shivani.sud@unchealth.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Cognitive workload (CWL) (time frame: Baseline to 2 hours). 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 23 Sep 2026.