Patient Education, Radiotherapy
Conditions
Keywords
Educational Video, Patient Education, Radiotherapy
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.
Detailed description
This study is a prospective, randomized, parallel-group trial designed to evaluate the effectiveness of a generative artificial intelligence (AI)-based educational video compared with a conventional video in patients undergoing radiation therapy. Participants will be randomly assigned in a 1:1 ratio to one of two groups: (A) an AI-based avatar video group or (B) a conventional video group consisting of PowerPoint slides with voice narration. Both videos will be standardized to ensure comparable duration (approximately 5 minutes), identical core content, and equivalent summary points to minimize variability in information delivery. After providing informed consent, participants will be asked to complete structured questionnaires at three time points: before viewing the video (baseline), immediately after viewing the video, and during the first week of radiation therapy. The assessments will include measures of anxiety, knowledge comprehension, and satisfaction with the educational material. Baseline assessments will be used as reference values for evaluating changes over time. The primary objective is to compare post-intervention anxiety levels between the two groups. Secondary objectives include comparisons of knowledge comprehension, satisfaction with the educational video, and changes in anxiety over time. Statistical analyses will be performed based on the intention-to-treat principle. Descriptive statistics will be used to summarize baseline characteristics. Changes in outcomes over time and between groups will be analyzed using appropriate statistical models for repeated measures. Missing data will not be imputed; analyses will be conducted using available data for each outcome measure. This study will be conducted at two institutions and aims to provide evidence on whether AI-based educational tools can improve patient understanding and reduce anxiety in the clinical setting.
Interventions
OTHERAI-based educational 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.
OTHERConventional educational video (PPT + narration)
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.
Sponsors
Yonsei University
Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 20 years * Patients scheduled for radiotherapy * Ability to watch video and comprehend audio, as assessed by the investigator * ECOG performance status 0-1
Exclusion criteria
* Patients unable to complete questionnaires due to cognitive impairment or psychiatric disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety score (APAIS) | T1(Immediately after the intervention /during the pre-treatment consultation visit) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety level (K-HADS-A) | T1(Immediately after the intervention (during the pre-treatment consultation visit) | Anxiety will be measured using the Korean version of the Hospital Anxiety and Depression Scale - Anxiety subscale (K-HADS-A) (score range: 0-21; higher scores indicate greater anxiety). Change from baseline will be analyzed using a linear mixed model. |
| Anxiety level (APAIS, K-HADS-A) | T2(During the first week of treatment) | Anxiety will be measured using both APAIS an d K-HADS-A during the first week of treatment. Baseline scores assessed Anxiety will be measured using the Amsterdam Preoperative Anxiety and Information Scale (APAIS) (6-30; higher = greater anxiety) and the Korean version of the Hospital Anxiety and Depression Scale - Anxiety subscale (K-HADS-A) (0-21; higher = greater anxiety). Change from baseline will be analyzed using a linear mixed model. |
| Knowledge score | T1(Immediately after the intervention /during the pre-treatment consultation visit) and T2(during the first week of treatment) | Knowledge will be assessed using a structured questionnaire (score range: 0-10; higher scores indicate better knowledge). Change from baseline will be analyzed using a linear mixed model. |
| Satisfaction score | T1(Immediately after the intervention /during the pre-treatment consultation visit) and T2(during the first week of treatment) | Participant satisfaction with the educational intervention will be assessed Satisfaction will be assessed using a standardized questionnaire (score range: 0-10; higher scores indicate greater satisfaction). Change over time will be analyzed using a linear mixed model. |
Countries
South Korea
Contacts
CONTACTHwaKyung Byun, MD, PhD
PRINCIPAL_INVESTIGATORHwakyung Byun, MD,PhD
ongin Severance Hospital
Outcome results
None listed