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NCT Number: NCT07634978

Development and Application of an AI Chatbot for Perioperative Health Education in Thyroid Cancer Patients

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).

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Key information

Conditions

Thyroid Cancer Endocrine Gland Neoplasms Endocrine System Diseases Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Location status: Recruiting

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Routine Perioperative Health Education

Behavioral

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 Education

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Patient Activation and Self-Management Engagement

    Time frame: On the morning of hospital discharge

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

jiayan Cao

CONTACT

[email protected]

86+23340123-3130

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study title

Development and Application of an Artificial Intelligence Chatbot for Perioperative Health Education Among Thyroid Cancer Patients: A Quasi-Experimental Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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