NCT07550686

Brief Summary

This study aims to evaluate whether a generative artificial intelligence (AI)-based educational video is more effective than a conventional video in improving patient understanding and reducing anxiety before radiation therapy. In this prospective, randomized controlled study, participants will be assigned in a 1:1 ratio to either an AI-based avatar video group or a conventional video group consisting of PowerPoint slides with voice narration. Both videos will be standardized to have similar duration (approximately 5 minutes), identical key messages, and the same summary points. After providing informed consent, participants will complete questionnaires before and after watching the assigned video, as well as during the first week of treatment. Outcomes will include anxiety levels, knowledge comprehension, and satisfaction with the educational video. A total of 136 patients scheduled to undergo radiation therapy will be enrolled from two institutions. The findings of this study are expected to provide evidence on the effectiveness of AI-based educational tools in enhancing patient education and reducing pre-treatment anxiety.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Dec 2025Nov 2027

Study Start

First participant enrolled

December 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2027

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

April 10, 2026

Last Update Submit

April 23, 2026

Conditions

Keywords

Educational VideoPatient EducationRadiotherapy

Outcome Measures

Primary Outcomes (1)

  • Anxiety score (APAIS)

    Anxiety will be measured using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) (total score range: 6-30; higher scores indicate greater anxiety). Change from baseline will be analyzed using a linear mixed model.

    T1(Immediately after the intervention /during the pre-treatment consultation visit)

Secondary Outcomes (4)

  • Anxiety level (K-HADS-A)

    T1(Immediately after the intervention (during the pre-treatment consultation visit)

  • Anxiety level (APAIS, K-HADS-A)

    T2(During the first week of treatment)

  • Knowledge score

    T1(Immediately after the intervention /during the pre-treatment consultation visit) and T2(during the first week of treatment)

  • Satisfaction score

    T1(Immediately after the intervention /during the pre-treatment consultation visit) and T2(during the first week of treatment)

Study Arms (2)

AI-based Avatar Video

EXPERIMENTAL

Description: Participants will watch a generative AI-based educational video delivered through an avatar format. The video explains radiotherapy procedures, expected side effects, and self-care information. Duration is approximately 5 minutes. Intervention Type: Other Intervention Name: AI-based educational video Intervention Description: A standardized educational video generated using artificial intelligence avatar technology, designed to improve patient understanding and reduce anxiety prior to radiotherapy.

Other: AI-based educational video

PPT + Voice Narration Video

ACTIVE COMPARATOR

Description: Participants will watch a conventional educational video consisting of PowerPoint slides with voice narration. Content, duration (\~5 minutes), and key messages are equivalent to the experimental arm. Intervention Type: Other Intervention Name: Conventional educational video (PPT + narration) Intervention Description: A traditional educational video using slide-based presentation with voice narration covering radiotherapy-related information.

Other: Conventional educational video (PPT + narration)

Interventions

5-minute educational video using PowerPoint slides with voice narration covering identical content as the AI-based video, including radiotherapy procedures, side effects, and self-care information.

Also known as: Slide-based narrated video
PPT + Voice Narration Video

Standardized 5-minute educational video delivered via AI-generated avatar to explain radiotherapy procedures, expected side effects, and self-care information. Designed to improve patient understanding and reduce anxiety.

Also known as: Generative AI avatar video
AI-based Avatar Video

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 20 years
  • Patients scheduled for radiotherapy
  • Ability to watch video and comprehend audio, as assessed by the investigator
  • ECOG performance status 0-1

You may not qualify if:

  • Patients unable to complete questionnaires due to cognitive impairment or psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yongin Severance Hospital

Yongin-si, 365, South Korea

RECRUITING

Study Officials

  • Hwakyung Byun, MD,PhD

    ongin Severance Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

HwaKyung Byun, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study in which participants and investigators are aware of the assigned intervention due to the nature of the educational video formats.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants are randomly assigned in a 1:1 ratio to receive either a generative AI-based avatar educational video or a conventional PowerPoint-based video with voice narration.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 10, 2026

First Posted

April 24, 2026

Study Start

December 1, 2025

Primary Completion (Estimated)

May 28, 2027

Study Completion (Estimated)

November 28, 2027

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations