Evaluating the Role of ChatGPT in Educating Patients With Early-stage Hepatocellular Carcinoma

NCT06384950 | Recruiting

• 1 other identifier: 2023-11-005A
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

Liver cancer is a leading cause of cancer-related deaths in Taiwan, with its onset linked to factors like chronic liver conditions, cirrhosis, and genetic predispositions. According to the "Barcelona Clinic Liver Cancer (BCLC)" classification, early-stage liver cancer is demarcated by stages 0 to A. Upon such diagnosis, both patients and their families often have numerous questions and concerns, ranging from treatment choices to long-term outcomes. The research proposes a GPT-3.5-based chatbot to assist these patients by providing timely, personalized information, aiming to enrich their understanding of the disease and improve communication between patients and health professionals. The research methodology employs a Randomized Controlled Trial (RCT) design, dividing participants into a control cohort receiving standard patient education routine and an experimental cohort receiving both the AI chatbot and traditional education routine. The comparative analysis of these cohorts will determine the effectiveness of the AI intervention in improving patients' health literacy and satisfaction.

Conditions

Carcinoma, Hepatocellular

Keywords

ChatGPT; Patient Education

Outcome Measures

Primary Outcomes (2)

• Health literacy score of patients

  Primarily measured using the Liver Cancer Knowledge Scale. The scale consists of 20 questions with options including correct, incorrect, and unsure, with 14 correct answers and 6 incorrect ones (questions 4, 7, 11, 15, 18, 19). Each correct answer scores 5 points, while incorrect or unsure answers score 0 points. The score range is from 0 to 100, with a total score of 100 points.

  1 weeks to 1 month

• Satisfaction score with medical care

  It mainly includes satisfaction with traditional health education and AI-based health education tools. The Likert scale assessed the score, which offers options ranging from very dissatisfied (1) to very satisfied (5).

  1 weeks to 1 month

Secondary Outcomes (1)

• Degree of patient anxiety

  1 weeks to 1 month

Study Arms (2)

GPT-3.5-based educational

EXPERIMENTAL

Patients receive additional education using a GPT-3.5-based educational robot on top of the traditional education.

Behavioral: ChatGPT

Traditional education procedures

ACTIVE COMPARATOR

Patients receive standard traditional education procedures.

Behavioral: patient education with traditional methods.

Interventions

ChatGPT BEHAVIORAL

Patients receive additional education using a GPT-3.5-based educational robot on top of the traditional education.

Also known as: Add GPT-3.5 model for patient education

GPT-3.5-based educational

patient education with traditional methods. BEHAVIORAL

Patients receive standard traditional education procedures.

Traditional education procedures

Eligibility Criteria

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

You may qualify if:

• Patients with early-stage hepatocellular carcinoma from both gastroenterology and general surgery outpatient departments were included. Early-stage hepatocellular carcinoma is defined based on the Barcelona Clinic Liver Cancer (BCLC) staging as stages 0 to A.

You may not qualify if:

• Patients under the age of 18 or those currently undergoing treatment for other cancers.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Beitou District, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The research uses a Randomized Controlled Trial (RCT) methodology, dividing patients into a control group undergoing the conventional patient education routine, and an experimental group that leverages both the chatbot and traditional education. By comparing selected outcomes between the two groups, the experiment's effectiveness will be determined.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: To compare the educational effectiveness of a chatbot integrated with health education information to traditional health education methods. This comparison encompassed aspects such as the patient's health literacy and clinical satisfaction. Based on the findings, recommendations and improvements would be proposed to promote the application and development of large language models in the medical field.

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 25, 2024
• Study Start: March 22, 2024
• Primary Completion: November 29, 2024
• Study Completion: March 21, 2025
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)