Easy-to-use, Live, Interactive Support Avatar

NCT07715981 | Not Yet Recruiting

• 2 other identifiers: 15021NL-2026-0063
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cancer

Keywords

Education; Treatment; Side effects; Artificial Intelligence; Avatar; Video

Outcome Measures

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)

  2 days after consultation with an oncology nurse

Secondary Outcomes (1)

• Chatbot usability

  1 month after educational consultation with an oncology nurse

Other Outcomes (7)

• Unscheduled contact

  Three months after inclusion

• Emergency room visits

  Three months after inclusion

• Hospitalisations

  Three months after inclusion

Study Arms (2)

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.

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.

Other: No Interventions

Interventions

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.

Control group

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.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Mark Mulder: lead

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Mark Mulder Medical-oncologist, MD, PhD

CONTACT

+31-10-7040704; interne.oncology@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Model Details: A prospective, single-center, randomized controlled non-inferiority trial

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 21, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: At completion of the study
• Access Criteria: Through the Principal Investigator