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Information-providing Chatbot

The Development and Evaluation of a Co-designed, AI-based Information-providing Chatbot for Sarcoma Patients: A Pilot Randomised Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07505732
Enrollment
78
Registered
2026-04-01
Start date
2027-04-01
Completion date
2028-07-31
Last updated
2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma

Keywords

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

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.

Interventions

OTHERASCC (sarcoma-specific AI chatbot)

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).

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.

Sponsors

The Hong Kong Polytechnic University
Lead SponsorOTHER
Queen Mary Hospital, Hong Kong
CollaboratorOTHER
Prince of Wales Hospital, Shatin, Hong Kong
CollaboratorOTHER
Queen Elizabeth Hospital, Hong Kong
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* (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

Exclusion criteria

* (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

Design outcomes

Primary

MeasureTime frameDescription
Screening rateDuring the enrollment period of this project.Calculated by dividing the number of sarcoma patients screened by the research team by the number of sarcoma patients.
Eligibility rateDuring the enrollment period of this project.Calculated by dividing the number of participants who are eligible by the number who are screened.
Consent rateDuring the enrollment period of this project.Calculated by dividing the number of participants who were randomized into intervention and control groups by those provide consent.
Randomization rateDuring the enrollment period of this project.Calculated by dividing the number of participants who consent to join the study by the number who are eligible.
Attendance rateBaseline and immediately after intervention (T1)Calculated by dividing the number of participants who complete the intervention by those who are randomised
Retention rateBaseline and immediately after intervention (T1)Calculated by dividing the number of participants who remain in the study by those who are randomized. This will be calculated by groups.
Completion rateBaseline and immediately after intervention (T1)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.
Proportion of missing dataBaseline and immediately after intervention (T1)Calculated as the percentage of missing values in the dataset. Unknown or blank values will be considered missing values.
Adverse eventsimmediately after intervention (T1)Adverse events are defined as unfavourable and unintended events that are not present, or appear to have worsened during the study.

Secondary

MeasureTime frameDescription
Information satisfactionBaseline and immediately after intervention (T1)The EORTC QLQ-INFO25 will be used to evaluate participants' satisfaction with the information received. A four-point Likert scale is used to score 25 items ('nothing' = 1 to 'a lot' = 4), with higher scores indicating greater information satisfaction.
Anxiety and stressBaseline and immediately after intervention (T1)The Depression Anxiety Stress Scale-21 (DASS-21) will be used to assess anxiety and stress.(36) 21 items are scored using a four-point Likert scale, with higher score indicating more severe symptoms.
Self-efficacyBaseline and immediately after intervention (T1)Self-efficacy will be assessed using the Strategies Used by People to Promote Health (SUPPH) with good reliability and validity. This 28-item likert scale measure self-care self-efficacy, with higher scores indicating more positive perceptions of self-efficacy.
System Usability Scaleimmediately after intervention (T1)System Usability Scale (SUS) will be used to measure the usability of digital health solutions by 10 items rated on a 5-point Likert scale from 0-100. The chatbot will be considered highly usable if the mean score exceeds 68.

Contacts

CONTACTQi LIU, PhD
charlotte-qi.liu@polyu.edu.hk85255741349

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026