Thyroid CancerNCT07634978
Development and Application of an AI Chatbot for Perioperative Health Education in Thyroid Cancer Patients
A study testing Routine Perioperative Health Education and Coze-Based AI Chatbot Health Education in people with Thyroid Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the usefulness and effectiveness of a newly developed artificial intelligence (AI) chatbot for health education in thyroid cancer patients during the period around their surgery (the perioperative period). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Routine Perioperative Health Education and Coze-Based AI Chatbot Health Education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Aug 2026
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with thyroid cancer in accordance with the clinical diagnostic criteria, and confirmed by ultrasonography and histopathological examination.
- Scheduled to undergo elective surgery for thyroid cancer.
- Mentally competent to understand the study protocol, and voluntarily provided written informed consent to participate in this study.
Who cannot join
- Aged less than 18 years.
- Concurrently diagnosed with malignant tumors in other organs or severe complications/dysfunctions of other major organs.
- Patients who are anticipated to be unable to complete the study protocol due to plans for hospital/department transfer, or high risk of treatment discontinuation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
About this study
Official title: Development and Application of an Artificial Intelligence Chatbot for Perioperative Health Education Among Thyroid Cancer Patients: A Quasi-Experimental Study
The goal of this clinical trial is to evaluate the usefulness and effectiveness of a newly developed artificial intelligence (AI) chatbot for health education in thyroid cancer patients during the period around their surgery (the perioperative period). The main questions it aims to answer are:
Does the AI chatbot improve patients' readiness for discharge, quality of recovery, and active engagement in their own healthcare compared to traditional education methods?
Read more
How do patients rate the usability and friendliness of this new AI chatbot system?
Researchers will compare a group of patients who receive traditional health education (the control group) with a subsequent group of patients who use the new AI chatbot built on the "Coze" platform (the intervention group) to see if the AI chatbot leads to better recovery experiences and higher patient engagement.
Participants will be asked to:
Access and interact with the AI chatbot to receive personalized health guidance, ask questions, and get instant feedback during their hospital stay.
Complete a set of questionnaires on the morning of their hospital discharge to evaluate their recovery quality, readiness to leave the hospital, and level of engagement in their care.
Complete an extra survey regarding the usability and acceptability of the chatbot system (only for participants in the AI chatbot group).
Read the detailed description
Background and Rationale:
Thyroid cancer treatment and care involve long-term medication management and follow-up monitoring. While the application of Enhanced Recovery After Surgery (ERAS) protocols has significantly shortened the length of hospital stays, it has also reduced the time available for face-to-face clinician-patient communication. Traditional health education models often struggle to meet the continuous and diverse information needs of patients during the perioperative period. This study aims to develop a novel health education chatbot based on the "Coze" platform to provide personalized, instant, and interactive perioperative guidance for thyroid cancer patients, thereby exploring a new digital approach to patient education and supportive care.
Study Design and Timeline:
This study utilizes a non-randomized, sequentially controlled design (a before-after study) and consists of two consecutive phases:
Control Phase (Traditional Education): Patients admitted during this period will receive standard, routine perioperative health education provided by the nursing staff.
Intervention Phase (AI Chatbot Education): Following the control phase, the newly developed AI chatbot will be implemented. Patients admitted during this period will have access to the chatbot in addition to routine care.
The AI Chatbot Intervention:
The AI chatbot is designed to provide comprehensive, 24/7 interactive support. Its core function modules include pre-admission preparation, postoperative care guidance, medication management (such as thyroid hormone replacement therapy), diet and lifestyle advice, and follow-up scheduling. Patients can ask questions in natural language and receive immediate feedback tailored to their surgical stage.
Data Collection Procedure:
For both groups, clinical and survey data will be collected systematically. On the morning of hospital discharge, participants in both the control and intervention groups will be asked to complete a set of standardized questionnaires evaluating their quality of recovery, readiness for discharge, and level of patient activation. Additionally, participants in the intervention group will com
- Conditions
- Thyroid Cancer
- Being tested
- Routine Perioperative Health Education, Coze-Based AI Chatbot Health Education
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Perioperative Health EducationBehavioural
Participants in this group will receive standard, traditional perioperative health education. The intervention is delivered orally by three certified senior oncology nurses at 5 predefined clinical timeline milestones. A standardized health education protocol is followed, which comprehensively covers general information about thyroid cancer, pre-admission preparation, surgical day and postoperative care, symptom management, discharge instructions, medication adherence guidance, and transitional care. After hospital discharge, participants will receive routine follow-up support through the hospital's official mini-program platform's health consultation portal.
Coze-Based AI Chatbot Health EducationBehavioural
In addition to the routine health education received by the control group, participants in this group will interact with a novel, interactive health education chatbot developed on the "Coze" AI platform. The chatbot intervention framework consists of three core components:
User Guide \& Free Inquiry: Patients receive instructions on how to use the AI agent and can initiate unstructured, free-text inquiries in natural language based on their individual needs.
Proactive Health Education Push: The chatbot automatically pushes targeted health education modules to patients at predefined clinical milestones throughout the perioperative journey.
Interactive Precaution Explanations: The chatbot provides detailed, real-time explanations of postoperative precautions and self-care guidelines.
Furthermore, a dedicated technical and clinical maintenance team will continuously optimize the system's prompt words and interaction designs based on patient feedback and user behavioral analysis to enha
| Study group | Role | What they receive |
|---|---|---|
| Control Phase: Routine Health Education | Placebo comparator | Not described Receives: Behavioral: Routine Perioperative Health Education |
| Intervention Phase: Coze-Based AI Chatbot | Experimental | Not described Receives: Behavioral: Coze-Based AI Chatbot Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readiness for Hospital Discharge
Measured using the Readiness for Hospital Discharge Scale (RHDS). The scale consists of 23 items across four dimensions: personal status (7 items), knowledge of the disease (8 items), coping ability (3 items), and expected support (4 items). Each item is scored on a 0-10 scale. The total score ranges from 0 to 220, with higher scores indicating a higher and more sufficient readiness for hospital discharge. The overall Cronbach's alpha of the scale is 0.97.
Measured: On the morning of hospital discharge
Postoperative Quality of Recovery
Evaluated using the Chinese version of the 15-item Quality of Recovery Scale (QoR-15). It measures the patient's early postoperative recovery quality across five dimensions: physical comfort, independence, psychological support, emotional state, and pain. The total score ranges from 0 to 150, with higher scores representing a better and higher quality of recovery.
Measured: On the morning of hospital discharge
System Usability of the AI Chatbot
Measured exclusively in the intervention group using the System Usability Scale (SUS) to evaluate the overall usability and user satisfaction of the chatbot. The scale consists of 10 items covering three dimensions: effectiveness, learnability, and satisfaction. The total score ranges from 0 to 100, with higher scores indicating better system usability. A total score greater than 60 is generally considered acceptable and indicates good usability. The content validity index (CVI) of the scale is 0.822.
Measured: On the morning of hospital discharge.
Secondary outcomes (1)
Patient Activation and Self-Management Engagement
Assessed using the Patient Activation Measure (PAM) to evaluate the patients' proactive engagement and readiness for self-management. The scale encompasses 4 dimensions: knowledge, beliefs, skills, and actions. Total scores are typically converted to a standardized 0-100 scale, where higher scores reflect greater patient activation and better self-management capability. The Cronbach's alpha is 0.865.
Measured: On the morning of hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Jan 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayan Cao, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634978
- Sponsor's protocol ID
- bc20252884
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of an Artificial Intelligence Chatbot for Perioperative Health Education Among Thyroid Cancer Patients: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07634978
- Acronym / sponsor ID
- bc20252884
- Conditions
- Thyroid Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 9 Jun 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.
The goal of this clinical trial is to evaluate the usefulness and effectiveness of a newly developed artificial intelligence (AI) chatbot for health education in thyroid cancer patients during the period around their surgery (the perioperative period). The main questions it aims to answer are:
Does the AI chatbot improve patients' readiness for discharge, quality of recovery, and active engagement in their own healthcare compared to traditional education methods?
How do patients rate the usability and friendliness of this new AI chatbot system?
Researchers will compare a group of patients who receive traditional health education (the control group) with a subsequent group of patients who use the new AI chatbot built on the "Coze" platform (the intervention group) to see if the AI chatbot leads to better recovery experiences and higher patient engagement.
Participants will be asked to:
Access and interact with the AI chatbot to receive personalized health guidance, ask questions, and get instant feedback during their hospital stay.
Complete a set of questionnaires on the morning of their hospital discharge to evaluate their recovery quality, readiness to leave the hospital, and level of engagement in their care.
Complete an extra survey regarding the usability and acceptability of the chatbot system (only for participants in the AI chatbot group).
Detailed description
Background and Rationale:
Thyroid cancer treatment and care involve long-term medication management and follow-up monitoring. While the application of Enhanced Recovery After Surgery (ERAS) protocols has significantly shortened the length of hospital stays, it has also reduced the time available for face-to-face clinician-patient communication. Traditional health education models often struggle to meet the continuous and diverse information needs of patients during the perioperative period. This study aims to develop a novel health education chatbot based on the "Coze" platform to provide personalized, instant, and interactive perioperative guidance for thyroid cancer patients, thereby exploring a new digital approach to patient education and supportive care.
Study Design and Timeline:
This study utilizes a non-randomized, sequentially controlled design (a before-after study) and consists of two consecutive phases:
Control Phase (Traditional Education): Patients admitted during this period will receive standard, routine perioperative health education provided by the nursing staff.
Intervention Phase (AI Chatbot Education): Following the control phase, the newly developed AI chatbot will be implemented. Patients admitted during this period will have access to the chatbot in addition to routine care.
The AI Chatbot Intervention:
The AI chatbot is designed to provide comprehensive, 24/7 interactive support. Its core function modules include pre-admission preparation, postoperative care guidance, medication management (such as thyroid hormone replacement therapy), diet and lifestyle advice, and follow-up scheduling. Patients can ask questions in natural language and receive immediate feedback tailored to their surgical stage.
Data Collection Procedure:
For both groups, clinical and survey data will be collected systematically. On the morning of hospital discharge, participants in both the control and intervention groups will be asked to complete a set of standardized questionnaires evaluating their quality of recovery, readiness for discharge, and level of patient activation. Additionally, participants in the intervention group will com
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Phase: Routine Health Education | Placebo comparator | Behavioral: Routine Perioperative Health Education |
| Intervention Phase: Coze-Based AI Chatbot | Experimental | Behavioral: Coze-Based AI Chatbot Health Education |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed with thyroid cancer in accordance with the clinical diagnostic criteria, and confirmed by ultrasonography and histopathological examination.
- Scheduled to undergo elective surgery for thyroid cancer.
- Mentally competent to understand the study protocol, and voluntarily provided written informed consent to participate in this study.
Key exclusion criteria (3 listed)
- Aged less than 18 years.
- Concurrently diagnosed with malignant tumors in other organs or severe complications/dysfunctions of other major organs.
- Patients who are anticipated to be unable to complete the study protocol due to plans for hospital/department transfer, or high risk of treatment discontinuation.
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 |
|---|---|---|
| Routine Perioperative Health EducationParticipants in this group will receive standard, traditional perioperative health education. The intervention is delivered orally by three certified senior oncology nurses at 5 predefined clinical timeline milestones. A standardized health education protocol is followed, which comprehensively covers general information about thyroid cancer, pre-admission preparation, surgical day and postoperative care, symptom management, discharge instructions, medication adherence guidance, and transitional care. After hospital discharge, participants will receive routine follow-up support through the hospital's official mini-program platform's health consultation portal. | Behavioural | Control Phase: Routine Health Education |
| Coze-Based AI Chatbot Health EducationIn addition to the routine health education received by the control group, participants in this group will interact with a novel, interactive health education chatbot developed on the "Coze" AI platform. The chatbot intervention framework consists of three core components: User Guide \& Free Inquiry: Patients receive instructions on how to use the AI agent and can initiate unstructured, free-text inquiries in natural language based on their individual needs. Proactive Health Education Push: The chatbot automatically pushes targeted health education modules to patients at predefined clinical milestones throughout the perioperative journey. Interactive Precaution Explanations: The chatbot provides detailed, real-time explanations of postoperative precautions and self-care guidelines. Furthermore, a dedicated technical and clinical maintenance team will continuously optimize the system's prompt words and interaction designs based on patient feedback and user behavioral analysis to enha | Behavioural | Intervention Phase: Coze-Based AI Chatbot |
Primary outcome
Readiness for Hospital Discharge
Time frame: On the morning of hospital discharge
Measured using the Readiness for Hospital Discharge Scale (RHDS). The scale consists of 23 items across four dimensions: personal status (7 items), knowledge of the disease (8 items), coping ability (3 items), and expected support (4 items). Each item is scored on a 0-10 scale. The total score ranges from 0 to 220, with higher scores indicating a higher and more sufficient readiness for hospital discharge. The overall Cronbach's alpha of the scale is 0.97.
Postoperative Quality of Recovery
Time frame: On the morning of hospital discharge
Evaluated using the Chinese version of the 15-item Quality of Recovery Scale (QoR-15). It measures the patient's early postoperative recovery quality across five dimensions: physical comfort, independence, psychological support, emotional state, and pain. The total score ranges from 0 to 150, with higher scores representing a better and higher quality of recovery.
System Usability of the AI Chatbot
Time frame: On the morning of hospital discharge.
Measured exclusively in the intervention group using the System Usability Scale (SUS) to evaluate the overall usability and user satisfaction of the chatbot. The scale consists of 10 items covering three dimensions: effectiveness, learnability, and satisfaction. The total score ranges from 0 to 100, with higher scores indicating better system usability. A total score greater than 60 is generally considered acceptable and indicates good usability. The content validity index (CVI) of the scale is 0.822.
1 secondary outcome
Patient Activation and Self-Management Engagement
Time frame: On the morning of hospital discharge
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 9 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine Perioperative Health Education and Coze-Based AI Chatbot Health Education in people with Thyroid Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 jiayan Cao (86+23340123-3130, Caojiayan_1976@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readiness for Hospital Discharge (time frame: On the morning of hospital discharge). The study lists 3 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 9 Jun 2026.