BaiXiaoAi AI Companion for Cancer Patient Follow-up

Application of BaiXiaoAi Companion AI in the Diagnosis, Treatment, and Follow-up Management of Oncology Patients: A Single-Center, Prospective, Exploratory Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Artificial Intelligence; Symptoms and Signs; Needs Assessment; Artificial Intelligence Mobile Application
• Intervention / Treatment: Other: No Intervention: Observational Cohort

Detailed Description

This is a prospective, single-center, exploratory clinical study aiming to comprehensively assess the diagnostic accuracy, user engagement efficacy, and subjective user experience of the BaiXiaoAi Companion AI system in the context of clinical patient management.

Following the voluntary signing of the informed consent document and formal enrollment into the study cohort, each participant will be assigned to a dedicated WeChat group adopting a "Doctor-Nurse-Patient-AI" quadruple collaborative model. Within this closed communication platform, the BaiXiaoAi Companion AI is programmed to perform two core functions: first, it delivers real-time, contextually tailored responses to patients' inquiries, symptom descriptions, and daily health-related communications shared within the group; second, it proactively disseminates personalized, evidence-based content covering disease-specific management protocols, medication adherence guidance, lifestyle modification recommendations, and targeted patient education materials. These interventions are designed to facilitate seamless interaction between medical providers and patients while leveraging AI-driven tools to augment the continuity of care outside of traditional clinical settings.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Shuhang Wang, PhD; Phone Number: 13581809307; Email: wangshuhang@cicams.ac.cn
• Study Contact Backup: Name: Dandan Cui, MD; Phone Number: +86 0316-5916013; Email: cuidan@cicams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Total Study Population; This is an observational study with no predefined study groups	Other: No Intervention: Observational Cohort; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Study Director: Shuhang Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): January 14, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: February 1, 2026
• First Submitted That Met QC Criteria: February 1, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 1, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Patient satisfaction; Symptom management; Cancer patients; Emotional support; WeChat-based AI companion; Tumor patients,; Clinical needs assessment
• Additional Relevant MeSH Terms: Pathological Conditions, Signs and Symptoms; Behavior; Treatment Adherence and Compliance; Health Behavior; Signs and Symptoms; Patient Satisfaction
• Other Study ID Numbers: NCCH0047

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No