NCT07396142

Brief Summary

This is a prospective, single-center, exploratory study designed to evaluate the accuracy, user engagement, and user experience of the BaiXiaoAi Companion AI. Upon signing the informed consent form and enrollment, a dedicated "Doctor-Nurse-Patient-AI" WeChat group will be established for each participant. Within the group, the BaiXiaoAi AI will provide timely responses based on patient communications and proactively push information regarding disease management and patient education.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jan 2026

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Jan 2026Nov 2027

Study Start

First participant enrolled

January 14, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

February 9, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

February 1, 2026

Last Update Submit

February 1, 2026

Conditions

Symptoms and SignsArtificial IntelligenceArtificial Intelligence Mobile ApplicationNeeds Assessment

Keywords

WeChat-based AI companionTumor patients,Cancer patientsPatient satisfactionSymptom managementEmotional supportClinical needs assessment

Outcome Measures

Primary Outcomes (1)

  • Accuracy and safety of AI-assisted patient communication

    The accuracy and safety of the AI-assisted communication tool will be assessed by monitoring the occurrence and severity of AI-related safety events during the study period. Safety events include misinformation, misunderstanding, inappropriate emotional responses, or potential risks related to medical decision-making attributable to the AI tool. Events are classified into four levels (Grade 0-3), where Grade 0 indicates no issue and Grade 3 indicates a serious error with potential medical risk.

    Up to 12 months

Study Arms (1)

Total Study Population

This is an observational study with no predefined study groups

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational CohortOTHER

This is an observational study. No experimental intervention (including drugs, devices, etc.) will be administered to the participants. The investigators will only collect clinical data and follow-up outcomes of the participants according to the study protocol.

Total Study Population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients diagnosed with malignant neoplasms who are undergoing cancer treatment or follow-up at a single study center, as well as their primary caregivers. Participants are enrolled after providing informed consent and are followed prospectively for observational data collection related to communication needs and usage patterns during routine care.

You may qualify if:

  • Adults aged 18 years or older;
  • Patients with a confirmed diagnosis of malignant neoplasms who are currently undergoing treatment or in follow-up, or their primary caregivers;
  • Able to read and communicate in Chinese and independently use WeChat;
  • Willing and able to provide informed consent.

You may not qualify if:

  • Presence of severe psychiatric disorders (e.g., schizophrenia, bipolar disorder) or cognitive impairment (MMSE score \< 24);
  • Inability to use WeChat or communicate in Chinese;
  • Considered by the investigators to be unsuitable for participation due to psychological or physical conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Signs and SymptomsPatient Satisfaction

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Shuhang Wang

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    STUDY DIRECTOR

Central Study Contacts

Dandan Cui, MD

CONTACT

+86 0316-5916013cuidan@cicams.ac.cn

Shuhang Wang, PhD

CONTACT

13581809307wangshuhang@cicams.ac.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Office of Clinical Trial Center, CancerIHCAMS

Study Record Dates

First Submitted

February 1, 2026

First Posted

February 9, 2026

Study Start

January 14, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

February 9, 2026

Record last verified: 2026-01