NCT07634978

Brief 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). 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress68%
Jan 2026Aug 2026

Study Start

First participant enrolled

January 1, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

June 3, 2026

Last Update Submit

June 3, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    On the morning of hospital discharge.

Secondary Outcomes (1)

  • Patient Activation and Self-Management Engagement

    On the morning of hospital discharge

Study Arms (2)

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

Interventions

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.

Control Phase: Routine Health Education

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

Intervention Phase: Coze-Based AI Chatbot

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Nurse

Study Record Dates

First Submitted

June 3, 2026

First Posted

June 9, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations