CancerELISANCT07715981
Easy-to-use, Live, Interactive Support Avatar
A study testing AI-generated education: AI generated video's and a life-like, interactive avatar in people with Cancer, run by Dr. Mark Mulder at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- AI-generated education: AI generated video's and a life-like, interactive avatar
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 5 Oct 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Has participated in this study for a previous line of anti-cancer treatment education.
- Significant cognitive impairment.
- Uncorrected visual or hearing impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus University Medical Centre
Rotterdam, 3015 GD
Mark Mulder, MD, PhD, +31-107041733, m.mulder.3@erasmusmc.nl
About this study
Official title: 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.
Read more
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.
- Conditions
- Cancer
- Being tested
- AI-generated education: AI generated video's and a life-like, interactive avatar, No Interventions
- Keywords
- Education, Treatment, Side effects, Artificial Intelligence, Avatar, Video
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-generated education: AI generated video's and a life-like, interactive avatarBehavioural
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 InterventionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | 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. Receives: Behavioral: AI-generated education: AI generated video's and a life-like, interactive avatar |
| Control group | Active comparator | 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. Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Information recall
The score on the Netherlands Patient Information Recall Questionnaire (NPIRQ) (numerical value 0-100; minimum 0; maximum 100; higher is better)
Measured: 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)
Measured: 1 month after educational consultation with an oncology nurse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start5 Oct 2026
- Primary completion1 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, single-center, randomized controlled non-inferiority trial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Mark Mulder
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Mark Mulder, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715981
- Sponsor's protocol ID
- 15021
- Other IDs
- NL-2026-0063
- Acronym
- ELISA
- Status last verified
- Oct 2026
- First submitted
- 15 Jul 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymized data as described in the outcome measures
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 39317034Nguyen 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ELISA: Easy-to-use, Live, Interactive Support Avatar
- ClinicalTrials.gov ID
- NCT07715981
- Acronym / sponsor ID
- ELISA / 15021
- Conditions
- Cancer
- Keywords
- Education, Treatment, Side effects, Artificial Intelligence, Avatar, Video
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dr. Mark MulderUniversity, hospital or other
- Study start
- 5 Oct 2026 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, single-center, randomized controlled non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Behavioral: AI-generated education: AI generated video's and a life-like, interactive avatarParticipants 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. |
| Control group | Active comparator | Other: No InterventionsParticipants in the control group will receive information about their cancer treatment in the traditional manner, through an educational session provided by an oncology nurse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- Has participated in this study for a previous line of anti-cancer treatment education.
- Significant cognitive impairment.
- Uncorrected visual or hearing impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-generated education: AI generated video's and a life-like, interactive avatarWith 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. | Behavioural | Study group |
| No InterventionsStandard 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. | Other | Control group |
Primary outcome
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)
1 secondary outcome
Chatbot usability
Time frame: 1 month after educational consultation with an oncology nurse
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 39317034Oldhoff-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.
- Background: PubMed 30264632Nguyen 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.
- Individual participant dataSharing planned: Yes. Pseudonymized data as described in the outcome measures
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-generated education: AI generated video's and a life-like, interactive avatar in people with Cancer, run by Dr. Mark Mulder at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Mulder Medical-oncologist, MD, PhD (+31-10-7040704, interne.oncology@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Information recall (time frame: 2 days after consultation with an oncology nurse). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07715981, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.