SarcomaNCT07505732
Information-providing Chatbot
A study testing ASCC (sarcoma-specific AI chatbot) and Routine Clinical Care in people with Sarcoma, run by The Hong Kong Polytechnic University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- ASCC (sarcoma-specific AI chatbot) and Routine Clinical Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2027to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- (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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Development and Evaluation of a Co-designed, AI-based Information-providing Chatbot for Sarcoma Patients: A Pilot Randomised Controlled 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.
- Conditions
- Sarcoma
- Being tested
- ASCC (sarcoma-specific AI chatbot), Routine Clinical Care
- Keywords
- sarcoma, health information, artificial intelligence, ChatGPT, chatbot, unmeet needs, cancer
- Medical subject headings
- Sarcoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Routine Clinical CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ASCC | Experimental | An AI-based sarcoma chatbot building on ChatGPT (ASCC) using a co-design approach. Receives: Other: ASCC (sarcoma-specific AI chatbot) |
| Control | Other | The standard information from doctor-patient consultations and hospital Receives: Other: Routine Clinical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening rate
Calculated by dividing the number of sarcoma patients screened by the research team by the number of sarcoma patients.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: immediately after intervention (T1)
Secondary outcomes (4)
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.
Measured: Baseline and immediately after intervention (T1)
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.
Measured: Baseline and immediately after intervention (T1)
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.
Measured: Baseline and immediately after intervention (T1)
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.
Measured: immediately after intervention (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start1 Apr 2027 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, Queen Elizabeth Hospital, Hong Kong
- Responsible party
- Principal investigator, LIU Qi Charlotte, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505732
- Sponsor's protocol ID
- ASCC Intervention
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Evaluation of a Co-designed, AI-based Information-providing Chatbot for Sarcoma Patients: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07505732
- Acronym / sponsor ID
- ASCC Intervention
- Conditions
- Sarcoma
- Keywords
- sarcoma, health information, artificial intelligence, ChatGPT, chatbot, unmeet needs, cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, Queen Elizabeth Hospital, Hong Kong
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASCC | Experimental | Other: ASCC (sarcoma-specific AI chatbot)An AI-based sarcoma chatbot building on ChatGPT (ASCC) using a co-design approach. |
| Control | Other | Other: Routine Clinical CareThe standard information from doctor-patient consultations and hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (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
Key exclusion criteria (4 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASCC (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). | Other | ASCC |
| Routine Clinical CareParticipants 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. | Other | Control |
Primary outcome
Screening rate
Time frame: During 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 rate
Time frame: During the enrollment period of this project.
Calculated by dividing the number of participants who are eligible by the number who are screened.
Consent rate
Time frame: During 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 rate
Time frame: During 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 rate
Time frame: Baseline and immediately after intervention (T1)
Calculated by dividing the number of participants who complete the intervention by those who are randomised
Retention rate
Time frame: Baseline 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 rate
Time frame: Baseline 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 data
Time frame: Baseline 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 events
Time frame: immediately after intervention (T1)
Adverse events are defined as unfavourable and unintended events that are not present, or appear to have worsened during the study.
4 secondary outcomes
Information satisfaction
Time frame: Baseline and immediately after intervention (T1)
Anxiety and stress
Time frame: Baseline and immediately after intervention (T1)
Self-efficacy
Time frame: Baseline and immediately after intervention (T1)
System Usability Scale
Time frame: immediately after intervention (T1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing ASCC (sarcoma-specific AI chatbot) and Routine Clinical Care in people with Sarcoma, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qi LIU, PhD (85255741349, charlotte-qi.liu@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Screening rate (time frame: During the enrollment period of this project.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.