Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

20. juli 2026 oppdatert av: 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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

100

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
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.
Aktiv komparator: 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.
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Information recall
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Chatbot usability
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Unscheduled contact
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Three months after inclusion
- Number of times the interactive avatar has been visited (integer number, higher is better)
Three months after inclusion
Avatar exposure
Tidsramme: Three months after inclusion
- Average duration of visit to the interactive avatar (seconds, minimum=0, maximum 1200s, higher is better)
Three months after inclusion

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. mars 2027

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

15. juli 2026

Først innsendt som oppfylte QC-kriteriene

20. juli 2026

Først lagt ut (Faktiske)

21. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 15021
  • NL-2026-0063 (Annet stipend/finansieringsnummer: Gilead Sciences Benelux B.V.)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Pseudonymized data as described in the outcome measures

IPD-delingstidsramme

At completion of the study

Tilgangskriterier for IPD-deling

Through the Principal Investigator

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere