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AI 'Zhiliao Doctor' aims to ease anxiety in breast cancer patients on CDK4/6 inhibitors

NCT ID NCT07409298

Symptom relief Sponsor: Tianjin Medical University Cancer Institute and Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests whether an AI-based management platform, called 'Zhiliao Doctor,' can reduce anxiety and depression in 300 breast cancer patients taking CDK4/6 inhibitors at home. Participants are randomly assigned to standard care, the AI platform, or personalized follow-up calls. The study measures changes in mood, quality of life, and medication adherence over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Zhiliao Doctor AI management platform (device) and tailored active follow-up (behavioral intervention)
What this could lead to
If successful, this could show that AI-based support helps breast cancer patients feel less anxious and depressed while managing their treatment at home.
What could go wrong
This is a relatively small, early-stage trial focused on psychological outcomes, not survival. The AI platform may not significantly improve mental health, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Females aged ≥ 18 years, regardless of menopausal status. * Diagnosis of HR+/HER2- breast cancer. * Currently receiving or scheduled to receive CDK4/6 inhibitor therapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * No history of severe psychiatric disorders (e.g., bipolar disorder, schizophrenia). * Baseline psychological state sufficient to understand and participate in psychological interventions. * Currently engaged in a rehabilitation plan, including exercise therapy and physical therapy. * Willingness to provide written informed consent. * Capability to perform online operations via smartphone or computer. Exclusion Criteria: * Severe complications (e.g., heart disease, severe hepatic or renal dysfunction) that render the patient unable to tolerate CDK4/6i therapy. * History of severe psychiatric illness (e.g., severe depression, bipolar disorder, or schizophrenia) that precludes self-assessment. * Other malignant tumors within the past 5 years (excluding specific cured carcinomas). * Pregnant or breastfeeding women. * Positive baseline pregnancy test for women of childbearing potential. * Inability to adapt to or intolerance of the AI virtual doctor's intervention formats. * Any other condition that the investigator deems unsuitable for participation in the study.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer mixed anxiety and depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer CDK4/6 inhibitors Depression anxiety disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 300000, China

More trials for these conditions

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