Easy-to-use, Live, Interactive Support Avatar (ELISA)

July 20, 2026 updated by: Dr. Mark Mulder

ELISA: Easy-to-use, Live, Interactive Support Avatar

Patients starting new cancer treatment must absorb complex information (treatment schedule, medication, side effects, safety instructions), often while coping with a new diagnosis or progression. Recall averages around 60%, with lower rates after bad-news consultations, so information often needs repeating before treatment starts, adding to nurse workload.

Dutch cancer incidence is projected to rise from 118,000 (2019) to ~156,000 diagnoses/year by 2032, with ~1.4 million cancer survivors by then, compounding existing staff shortages. Existing digital tools (websites, videos) offer only static, non-personalized information, whereas LLM-based systems allow natural-language, personalized interaction.

ELISA pairs AI-generated educational videos with an interactive avatar restricted to physician-approved content, referring patients to their care team otherwise. This trial tests whether ELISA plus shortened nurse-led education yields non-inferior recall versus standard education, alongside patient experience measures.

Objective(s) The primary objective of this study is to determine whether AI-supported education consisting of AI-generated videos and an interactive, life-like avatar, in addition to shortened nurse-led education, is non-inferior to standard nurse-led education alone with respect to patients' recall of treatment information when starting a new line of anti-cancer treatment. The secondary objective is to assess patients' experience with and usage of the AI-supported patient education.

Study type A prospective, single-center, randomized controlled non-inferiority trial Study population Adult patients, 18 years or older, who have an indication to start a new line of anti-cancer therapy at Erasmus MC Medical Oncology Methods Eligible patients, after giving eConsent, are randomized 1:1 to the control or study group. The study group gets access to ELISA. Both groups will receive an educational session with an oncology nurse. Two days after the educational session both groups receive a digital version of the Netherlands Patient Information Recall Questionnaire (NPIRQ) to test information retention. The study group will receive an additional online Chatbot Usability Questionnaire (CUQ) one month after getting access to ELISA.

Burden and risks The additional burden for participants in participating in this study is minimal and consists of watching an informational video of less than 10 minutes and completing brief questionnaires, which will take no more than 40 minutes in total. The AI-generated educational videos are static and its content is based on the existing informational brochures for oncologic treatments, which are thoroughly reviewed by oncologists and nurses. The interactive, life-like avatar is based on a large language model (LLM). As with all LLM's, there is a small chance it may occasionally hallucinate, giving inaccurate information. To minimize this risks, information to answer participants' questions is limited to information from the existing informational brochures for oncologic treatments. The interactive, life-like avatar cannot independently generate or retrieve new information beyond the scope of this information. Furthermore, the interactive life-like avatar is explicitly prompted to not answer questions beyond the information provided, to never give medical advice and to not ask for personal information.

Recruitment and consent Eligible patients are identified and informed by their oncologists during routine clinic visits. Eligible patients, after giving eConsent are randomized 1:1 to the control or study group.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18 years or older;
  • Indication to start a new line of anti-cancer treatment at Erasmus MC Medical Oncology;
  • Proficient in the Dutch language;
  • Has access to the internet;
  • Is capable using a digital device such as a computer, smartphone, or tablet;
  • Able and willing to provide informed consent.

Exclusion Criteria:

  • Has participated in this study for a previous line of anti-cancer treatment education.
  • Significant cognitive impairment.
  • Uncorrected visual or hearing impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study group
Participants in the study group will receive information through an AI-generated educational video and will have access to an interactive avatar that allows them to ask questions about their treatment. In addition, they will also receive a shortened educational consultation provided by an oncology nurse.
Behavioral: AI-generated education: AI generated video's and a life-like, interactive avatar
With the ELISA project, an AI-supported educational approach has been developed for patients starting a new line of cancer treatment. It combines AI-generated educational videos for specific oncological treatments - covering the treatment schedule, medication use, possible adverse effects, and safety instructions - with an accompanying interactive, life-like avatar that allows patients to ask additional questions in their own words about their treatment, medication, expected adverse effects, or how and when to contact a healthcare professional. All information used by the AI has been reviewed and approved by qualified physicians; to limit the risk of inaccurate or out-of-scope responses, the avatar answers only within this approved information and otherwise advises patients to contact their care team. It remains available at any time across different digital devices.
Active Comparator: Control group
Participants in the control group will receive information about their cancer treatment in the traditional manner, through an educational session provided by an oncology nurse.
Other: No Interventions
Standard of care: participants in the control group will receive information about their cancer treatment in the traditional manner, through an educational session provided by an oncology nurse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Information recall
Time Frame: 2 days after consultation with an oncology nurse
The score on the Netherlands Patient Information Recall Questionnaire (NPIRQ) (numerical value 0-100; minimum 0; maximum 100; higher is better)
2 days after consultation with an oncology nurse

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chatbot usability
Time Frame: 1 month after educational consultation with an oncology nurse
- Score on the Chatbot Usability Questionnaire (CUQ) (score 0-100; minimum = 0; maximum = 100; higher is better)
1 month after educational consultation with an oncology nurse

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unscheduled contact
Time Frame: Three months after inclusion
- Number of times patient had contact with physician or nurse outside scheduled appointments (integer number, lower is better)
Three months after inclusion
Emergency room visits
Time Frame: Three months after inclusion
- Any emergency room visits due to treatment toxicity of any grade during the first three months of the treatment (integer number, lower is better)
Three months after inclusion
Hospitalisations
Time Frame: Three months after inclusion
- Any hospitalizations due to treatment toxicity of any grade during the first three months (integer number, lower is better)
Three months after inclusion
Videos watched
Time Frame: Three months after inclusion
- Number of times the AI-generated videos have been watched (integer number, higher is better)
Three months after inclusion
Video exposure
Time Frame: Three months after inclusion
- Fraction of total duration of the AI-generated videos that has been watched (%, higher is better, minimum 0%, maximum 100%)
Three months after inclusion
Avatar use
Time Frame: Three months after inclusion
- Number of times the interactive avatar has been visited (integer number, higher is better)
Three months after inclusion
Avatar exposure
Time Frame: Three months after inclusion
- Average duration of visit to the interactive avatar (seconds, minimum=0, maximum 1200s, higher is better)
Three months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Mark Mulder

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

July 15, 2026

First Submitted That Met QC Criteria

July 20, 2026

First Posted (Actual)

July 21, 2026

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15021
  • NL-2026-0063 (Other Grant/Funding Number: Gilead Sciences Benelux B.V.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pseudonymized data as described in the outcome measures

IPD Sharing Time Frame

At completion of the study

IPD Sharing Access Criteria

Through the Principal Investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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