Symptoms and SignsNCT07396142
BaiXiaoAi AI Companion for Cancer Patient Follow-up
An observational study of Symptoms and Signs and Artificial Intelligence, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptoms and Signs, Artificial Intelligence, Artificial Intelligence Mobile Application
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 14 Jan 2026to 30 Nov 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Symptoms and Signs, Artificial Intelligence, Artificial Intelligence Mobile Application, Needs Assessment
- Being tested
- No Intervention: Observational Cohort
- Keywords
- WeChat-based AI companion, Tumor patients,, Cancer patients, Patient satisfaction, Symptom management, Emotional support, Clinical needs assessment
- Medical subject headings
- Signs and Symptoms, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Total Study Population | This is an observational study with no predefined study groups Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start14 Jan 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptoms and SignsStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NING_LI, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Shuhang Wang, Study director, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396142
- Sponsor's protocol ID
- NCCH0047
- Status last verified
- Jan 2026
- First submitted
- 1 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of BaiXiaoAi Companion AI in the Diagnosis, Treatment, and Follow-up Management of Oncology Patients: A Single-Center, Prospective, Exploratory Study
- ClinicalTrials.gov ID
- NCT07396142
- Acronym / sponsor ID
- NCCH0047
- Conditions
- Symptoms and Signs, Artificial Intelligence, Artificial Intelligence Mobile Application, Needs Assessment
- Keywords
- WeChat-based AI companion, Tumor patients,, Cancer patients, Patient satisfaction, Symptom management, Emotional support, Clinical needs assessment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 14 Jan 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 9 Feb 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total Study Population | – | Other: No Intervention: Observational CohortThis is an observational study with no predefined study groups |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| No Intervention: Observational CohortThis 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. | Other | Total Study Population |
Primary outcome
Accuracy and safety of AI-assisted patient communication
Time frame: Up to 12 months
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.
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 Feb 2026.
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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.
Shuhang Wang study director
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Questions about this trial
What is this clinical trial studying?
An observational study of Symptoms and Signs and Artificial Intelligence, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
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 4 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: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 Dandan Cui, MD (+86 0316-5916013, cuidan@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy and safety of AI-assisted patient communication (time frame: Up to 12 months). 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 Feb 2026.