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Not yet recruitingNCT07715981ELISAUpdated Jul 21, 2026

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An interventional study of AI-generated education: AI generated video's and a life-like, interactive avatar and No Interventions in Cancer, sponsored by Dr. Mark Mulder. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.

Sponsored by Dr. Mark Mulder · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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.

02

Conditions studied

  • Cancer

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Keywords

  • Education
  • Treatment
  • Side effects
  • Artificial Intelligence
  • Avatar
  • Video
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 100 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Dr. Mark Mulder is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Has participated in this study for a previous line of anti-cancer treatment education.
  • Significant cognitive impairment.
  • Uncorrected visual or hearing impairment.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BehavioralAI-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.

  • OtherNo 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.

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What researchers measure

Primary outcomes

  1. Information recall

    The score on the Netherlands Patient Information Recall Questionnaire (NPIRQ) (numerical value 0-100; minimum 0; maximum 100; higher is better)

    Time frame: 2 days after consultation with an oncology nurse

Secondary outcomes

  1. Chatbot usability

    \- Score on the Chatbot Usability Questionnaire (CUQ) (score 0-100; minimum = 0; maximum = 100; higher is better)

    Time frame: 1 month after educational consultation with an oncology nurse

Other outcomes

  1. Unscheduled contact

    \- Number of times patient had contact with physician or nurse outside scheduled appointments (integer number, lower is better)

    Time frame: Three months after inclusion

  2. Emergency room visits

    \- Any emergency room visits due to treatment toxicity of any grade during the first three months of the treatment (integer number, lower is better)

    Time frame: Three months after inclusion

  3. Hospitalisations

    \- Any hospitalizations due to treatment toxicity of any grade during the first three months (integer number, lower is better)

    Time frame: Three months after inclusion

  4. Videos watched

    \- Number of times the AI-generated videos have been watched (integer number, higher is better)

    Time frame: Three months after inclusion

  5. Video exposure

    \- Fraction of total duration of the AI-generated videos that has been watched (%, higher is better, minimum 0%, maximum 100%)

    Time frame: Three months after inclusion

  6. Avatar use

    \- Number of times the interactive avatar has been visited (integer number, higher is better)

    Time frame: Three months after inclusion

  7. Avatar exposure

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

    Time frame: Three months after inclusion

07

Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 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. PubMed 30264632 ↗

Individual participant data

Plan to share: Yes — Pseudonymized data as described in the outcome measures

Supporting information: Study protocol, Icf, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07715981
Lead sponsor
Dr. Mark Mulder
Responsible party
Dr. Mark Mulder (Principle Investigator, Erasmus Medical Center) — Sponsor-investigator
First posted
Jul 21, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Mar 1, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jul 21, 2026

Study contacts

Mark Mulder Medical-oncologist, MD, PhD
Contact
interne.oncology@erasmusmc.nl
+31-10-7040704

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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