Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07850700

Ambient AI Documentation in Oncology Consultations

Sponsor: National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos

View on ClinicalTrials.gov

Summary

This study tests whether an artificial intelligence (AI) system can help doctors write medical notes during cancer consultations. After a cancer patient is seen by a multidisciplinary team (a group of specialists who decide on the best treatment), they have a consultation with their oncologist to discuss the treatment plan. During this consultation, doctors must write detailed medical notes, which takes significant time and effort. In this study, an ambient AI system called VOCALI is used during oncology consultations at the National Cancer Center in Vilnius, Lithuania. Before the consultation begins, the doctor loads relevant pseudonymized clinical data from the electronic health record (such as diagnosis and treatment plan) into the system. During the consultation, VOCALI records the conversation (with the patient's consent) and combines it with the loaded clinical data to automatically generate a draft medical note in Lithuanian. Patients may ask the doctor to stop the recording at any time. The doctor then reviews the draft, makes any necessary corrections, and approves the final document. The AI does not make any medical decisions - the doctor is always responsible for the final note. What the study measures: The study has three main goals: * To assess the quality of the AI-generated notes, rated by two independent reviewers using the PDQI-10, a standardized documentation quality instrument translated into Lithuanian using forward-backward translation * To measure the time doctors spend reviewing and approving the AI-generated draft * To monitor safety - whether any AI errors could affect patient care The study also collects information on doctor workload, ease of use of the system, and patient satisfaction with the consultation. Who can participate: Adult patients (age 18 or older) attending a primary oncology consultation at the National Cancer Center in Vilnius, Lithuania, after a multidisciplinary team decision, who speak Lithuanian and provide written consent. Study details: 250 patients will be enrolled over 12 months. Each participant attends one consultation and completes a short satisfaction questionnaire (about 5 minutes). No additional visits are required. There is no comparator group - all participants receive the AI-assisted documentation. This is the first study to evaluate ambient AI documentation in the Lithuanian language and in the Lithuanian oncology setting.

Official title: Feasibility Study of Ambient Artificial Intelligence Documentation Systems for Oncology Consultations at the National Cancer Center

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

250

Start Date

2026-11-01

Completion Date

2027-12-31

Last Updated

2026-09-30

Healthy Volunteers

No

Interventions

DEVICE

Ambient AI documentation system

An ambient artificial intelligence documentation system that records the consultation audio, integrates relevant pseudonymized clinical data from the electronic health record (EHR), generates a speech transcript, and produces a draft clinical note (E025 form) for physician review and approval. The system does not make autonomous clinical decisions. The physician reviews, edits if necessary, and approves all AI-generated content before it is saved to the EHR.

Locations (1)

National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos

Vilnius, Vilnius City, Lithuania