Information-providing Chatbot

NCT07505732 | Not Yet Recruiting

• 1 other identifier: ASCC Intervention
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to develop and examine the feasibility and preliminary effectiveness of an AI-based sarcoma chatbot building on ChatGPT (ASCC) to address the information needs of sarcoma patients. We hypothesized: 1) the ASCC will demonstrate good usability; 2) the study will be feasible in terms of all feasibility indicators; 3) the experimental group will report improved satisfaction and self-efficacy, decreased anxiety and stress than the control groups upon completion of the intervention. The ASCC will be developed using a co-design approach. A pilot randomized controlled trial will then be conducted in the three oncology wards of collaborative hospitals. Seventy-eight sarcoma patients will be recruited and randomized to the experimental group (n=39) and the control group (n=39). The experimental group will use the ASCC available 24/7 via voice or text for disease-related questions for one month while the control group will receive usual care.

Conditions

Sarcoma

Keywords

sarcoma; health information; artificial intelligence; ChatGPT; chatbot; unmeet needs; cancer

Outcome Measures

Primary Outcomes (9)

• Screening rate

  Calculated by dividing the number of sarcoma patients screened by the research team by the number of sarcoma patients.

  During the enrollment period of this project.

• Eligibility rate

  Calculated by dividing the number of participants who are eligible by the number who are screened.

  During the enrollment period of this project.

• Consent rate

  Calculated by dividing the number of participants who were randomized into intervention and control groups by those provide consent.

  During the enrollment period of this project.

• Randomization rate

  Calculated by dividing the number of participants who consent to join the study by the number who are eligible.

  During the enrollment period of this project.

• Attendance rate

  Calculated by dividing the number of participants who complete the intervention by those who are randomised

  Baseline and immediately after intervention (T1)

• Retention rate

  Calculated by dividing the number of participants who remain in the study by those who are randomized. This will be calculated by groups.

  Baseline and immediately after intervention (T1)

• Completion rate

  Calculated by dividing the number of participants who returned questionnaires by the number of questionnaires distributed. Calculated by dividing the number of participants who remain in the study by those who are randomized. This will be calculated by groups.

  Baseline and immediately after intervention (T1)

• Proportion of missing data

  Calculated as the percentage of missing values in the dataset. Unknown or blank values will be considered missing values.

  Baseline and immediately after intervention (T1)

• Adverse events

  Adverse events are defined as unfavourable and unintended events that are not present, or appear to have worsened during the study.

  immediately after intervention (T1)

Secondary Outcomes (4)

• Information satisfaction

  Baseline and immediately after intervention (T1)

• Anxiety and stress

  Baseline and immediately after intervention (T1)

• Self-efficacy

  Baseline and immediately after intervention (T1)

• System Usability Scale

  immediately after intervention (T1)

Study Arms (2)

ASCC

EXPERIMENTAL

An AI-based sarcoma chatbot building on ChatGPT (ASCC) using a co-design approach.

Other: ASCC (sarcoma-specific AI chatbot)

Control

OTHER

The standard information from doctor-patient consultations and hospital

Other: Routine Clinical Care

Interventions

ASCC (sarcoma-specific AI chatbot) OTHER

The participants in the experimental group will access the ASCC via a webpage alongside standard information from health professionals for one month (15 minutes weekly).

ASCC

Routine Clinical Care OTHER

Participants in the control group will receive routine clinical care, including standard information from doctor-patient consultations (e.g., diagnosis, treatment, medical tests) and hospital provided sarcoma and treatment leaflet.

Control

Eligibility Criteria

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

You may qualify if:

• (1) diagnosed with soft tissue sarcoma;
• (2) receiving active treatment at any stage;
• (3) aged≥18 years;
• (4) able to speak Cantonese, Mandarin and English;
• (5) access to an electronic device enabling ASCC use

You may not qualify if:

• (1) patients with unstable physical or mental conditions;
• (2) inability to communicate logically;
• (3) using chatbots (e.g., ChatGPT, Deepseek) for sarcoma information in the last month;
• (4) mental health disorders documented by the medical system

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Queen Mary Hospital, Hong Kong: collaborator
• Prince of Wales Hospital, Shatin, Hong Kong: collaborator
• Queen Elizabeth Hospital, Hong Kong: collaborator

MeSH Terms

Conditions

Sarcoma; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Central Study Contacts

Qi LIU, PhD

CONTACT

85255741349; charlotte-qi.liu@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoc fellow

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: April 1, 2026
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: April 1, 2026

Record last verified: 2025-11