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NCT Number: NCT07715981

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AI-generated education: AI generated video's and a life-like, interactive avatar

Behavioral

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.

No interventions

Other

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 outcomes

  1. 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)

Secondary outcomes

  1. 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)

Other outcomes

  1. 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)
  2. 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)
  3. 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)
  4. Videos watched

    Time frame: Three months after inclusion

    • Number of times the AI-generated videos have been watched (integer number, higher is better)
  5. 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%)
  6. Avatar use

    Time frame: Three months after inclusion

    • Number of times the interactive avatar has been visited (integer number, higher is better)
  7. Avatar exposure

    Time frame: Three months after inclusion

    • Average duration of visit to the interactive avatar (seconds, minimum=0, maximum 1200s, higher is better)

Study contacts

Contact information is provided by the study sponsor or research team.

Mark Mulder Medical-oncologist, MD, PhD

CONTACT

[email protected]

+31-10-7040704

Sponsors and collaborators

Lead sponsor

Dr. Mark Mulder

Other

Registry information

Official study title

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

Acronym: ELISA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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