Easy-to-use, Live, Interactive Support Avatar
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI-generated education: AI generated video's and a life-like, interactive avatar, No Interventions.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ELISA: Easy-to-use, Live, Interactive Support Avatar
Overview
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.
Interventions
- 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 - 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.
Primary outcome measures
- Information recall [Time frame: 2 days after consultation with an oncology nurse]
Secondary outcome measures (1)
- Chatbot usability [Time frame: 1 month after educational consultation with an oncology nurse]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Oldhoff-Nuijsink C, Derksen ME, Engelsma T, Peute LWP, Fransen MP. Digital tools to support informed decision making among screening invitees in a vulnerable position for population-based cancer screening: A scoping review. Int J Med Inform. 2024 Dec;192:105625. doi: 10.1016/j.ijmedinf.2024.105625. Epub 2024 Sep 18. PMID 39317034
- Nguyen MH, Smets EMA, Bol N, Bronner MB, Tytgat KMAJ, Loos EF, van Weert JCM. Fear and forget: how anxiety impacts information recall in newly diagnosed cancer patients visiting a fast-track clinic. Acta Oncol. 2019 Feb;58(2):182-188. doi: 10.1080/0284186X.2018.1512156. Epub 2018 Sep 28. PMID 30264632
Identifiers
NCT: NCT07715981 · 15021 · NL-2026-0063