Information-providing Chatbot
ConditionSarcoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Hong Kong Polytechnic University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(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;
Disqualifiers
(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
Trial design
Design model
Parallel
Treatments tested in this trial
ASCC (sarcoma-specific AI chatbot)
Other interventionThe participants in the experimental group will access the ASCC via a webpage alongside standard information from health professionals for one month (15 minutes weekly).
Routine Clinical Care
Other interventionParticipants 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.
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: ASCCExperimental treatment 1 intervention
Group B: ControlOther 1 intervention
Trial outcomes
Primary outcomes
1
Screening rate
Calculated by dividing the number of sarcoma patients screened by the research team by the number of sarcoma patients.
Time frame
During the enrollment period of this project.2
Eligibility rate
Calculated by dividing the number of participants who are eligible by the number who are screened.
Time frame
During the enrollment period of this project.3
Consent rate
Calculated by dividing the number of participants who were randomized into intervention and control groups by those provide consent.
Time frame
During the enrollment period of this project.4
Randomization rate
Calculated by dividing the number of participants who consent to join the study by the number who are eligible.
Time frame
During the enrollment period of this project.Secondary outcomes
1
Information satisfaction
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.
Time frame
Baseline and immediately after intervention (T1)2
Anxiety and stress
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.
Time frame
Baseline and immediately after intervention (T1)3
Self-efficacy
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.
Time frame
Baseline and immediately after intervention (T1)4
System Usability Scale
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.
Time frame
immediately after intervention (T1)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The Hong Kong Polytechnic University
Lead sponsor
Queen Mary Hospital, Hong Kong
Collaborator
Prince of Wales Hospital, Shatin, Hong Kong
Collaborator
Queen Elizabeth Hospital, Hong Kong
Collaborator
Source ClinicalTrials.gov
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