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CDK4/6 InhibitorsNCT07409298

Impact of an Artificial Intelligence-Based Management Model on Psychological and Behavioral Outcomes in Breast Cancer Patients Undergoing Home CDK4/6 Inhibitor Therapy

A study testing The "Zhiliao Doctor" AI management platform and Tailored Active Follow-up Strategy in people with CDK4/6 Inhibitors and Depression Anxiety Disorder, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This version uses full terminology and flows well for a research proposal or paper. Primary Objective: To compare the intervention effects of an "AI-based management model," a "customized active follow-up model," and a "conventional patient education and follow-up model" on anxiety and depression in patients. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
The "Zhiliao Doctor" AI management platform and Tailored Active Follow-up Strategy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteChina
Study dates
5 Jul 2025to 30 May 2026
Phase
Interventional
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 300000

Other trials in China

About this study

Official title: Impact of an Artificial Intelligence-Based Management Model on Psychological and Behavioral Outcomes in Breast Cancer Patients Undergoing Home CDK4/6 Inhibitor Therapy: A Multicenter Randomized Controlled Trial

This version uses full terminology and flows well for a research proposal or paper.

Primary Objective: To compare the intervention effects of an "AI-based management model," a "customized active follow-up model," and a "conventional patient education and follow-up model" on anxiety and depression in patients.

Secondary Objectives: To evaluate the impact of these models on patients' quality of life (QoL), patient-reported adverse events, medication adherence, serological markers, progression-free survival (PFS), and overall survival (OS).

Being tested
The "Zhiliao Doctor" AI management platform, Tailored Active Follow-up Strategy
Keywords
AI-based Management Model, Customized Follow-up Mode, Psychological Intervention
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The "Zhiliao Doctor" AI management platformDevice

    Participants in Group A will receive standard clinical care supplemented by the 'Zhiliao Doctor' AI management platform. This 24/7 intelligent platform provides emotional companionship, medication reminders, and adverse reaction assessment based on CTCAE standards to enhance self-management and quality of life.

  • Tailored Active Follow-up StrategyBehavioural

    Participants receive tailored active follow-up, including personalized phone calls and SMS messages, managed by a professional follow-up center.

Study groups in NCT07409298
Study groupRoleWhat they receive
Group A: AI-integrated Care ModeExperimentalOn the basis of routine follow-up, the 'Zhiliao Doctor' AI management platform is utilized to provide intelligent services, including emotional companionship, medication reminders, and adverse reaction assessment and guidance.
Receives: Device: The "Zhiliao Doctor" AI management platform
Group B: Tailored Active Follow-up StrategyExperimentalReceiving personalized active follow-up services, such as phone calls and text messages, provided by the follow-up center.
Receives: Behavioral: Tailored Active Follow-up Strategy
Group C: Standard Patient Education and Follow-upNo interventionPatients receive routine medical advice and patient education.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Depression

    Depression is evaluated using the Self-rating Depression Scale (SDS). The SDS consists of 20 items, with each item scored on a 4-point scale ranging from 1 to 4. The raw total score is calculated by summing the scores of all items and is then converted into a standard score. The cutoff value for the standard score is set at 50. Higher scores indicate a greater severity of depression.

    Measured: 24weeks

  2. anxiety

    Anxiety is evaluated using the Self-rating Anxiety Scale (SAS). The scale consists of 20 items, with each item scored on a 4-point scale ranging from 1 to 4. The raw total score is obtained by summing the scores of all individual items and is subsequently converted into a standard score. The threshold for the standard score is 50. Higher scores reflect a greater severity of anxiety.

    Measured: 24weeks

Secondary outcomes (5)

  1. Quality of Life (QoL)

    The EORTC QLQ-C30 consists of five functional scales (physical, role, cognitive, emotional, and social), a global QoL scale, three symptom scales (fatigue, nausea and vomiting, and pain), single items assessing common symptoms (dyspnoea, loss of appetite, insomnia, constipation, and diarrhoea), and a single item assessing the perceived financial impact. After linear transformation, all scales and single-item measures range in score from 0 to 100. A higher score for a functional scale and the global QoL scale represents a higher level of functioning and a higher level of HRQoL. Conversely, a higher score for a symptom scale or item and the financial impact item indicates a higher level of symptom burden or financial impact.

    Measured: 24weeks

  2. PRO-CTCAE

    The PRO-CTCAE is a validated library of patient-reported items designed to measure 78 distinct symptomatic adverse events (AEs). For each AE, up to three separate attribute items assess the frequency, severity, and interference with daily activities over the past 7 days. Scores for each attribute can be reported individually or integrated into a single composite score ranging from 0 to 3 for each symptom using established algorithms. Higher individual or composite scores indicate greater symptom severity. Relevant PRO-CTCAE items are typically selected for a specific clinical trial based on prior evidence and/or the mechanism of action, and then compiled into a survey. In this trial, investigators selected 10 PRO-CTCAE symptoms based on CDK4/6 inhibitor-related side effects reported in the literature. The selected symptoms include: decreased appetite, nausea, constipation, diarrhea, dizziness, pain, insomnia, fatigue, dejection, and sadness.

    Measured: 24weeks

  3. Medication Adherence

    This study utilizes the Proportion of Days Covered (PDC) as a quantitative indicator of medication adherence. The formula is as follows: PDC = Number of days covered by medication during the observation period/Total number of days in the observation period× 100%.In this study, "high adherence" is defined as a PDC≥80%.

    Measured: 24weeks

  4. Overall Survival(OS)

    Measured: 2years

  5. Progression-Free Survival (PFS)

    Measured: 2years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2026
  2. Study start5 Jul 2025
  3. Primary completion24 May 2026 (estimated)
  4. Study completion30 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07409298
Sponsor's protocol ID
E20251024
Status last verified
Feb 2026
First submitted
20 Jan 2026
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Individual participant data (IPD) will not be shared primarily because the study involves highly sensitive psychological assessments (e.g., SAS and SDS scores) and detailed interaction logs with the "Zhiliao Doctor" AI platform; such unstructured data pose significant de-identification challenges and potential privacy risks. Additionally, the current institutional review board (IRB) approval and the informed consent forms signed by participants do not include provisions for the public sharing of individual-level raw data. Furthermore, as a multicenter study involving serological markers, data sharing is strictly limited by inter-institutional agreements, intellectual property protections, and national regulatory requirements for the management of human genetic resource data.

Questions about this trial

What is this clinical trial studying?

A study testing The "Zhiliao Doctor" AI management platform and Tailored Active Follow-up Strategy in people with CDK4/6 Inhibitors and Depression Anxiety Disorder, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

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 9 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depression (time frame: 24weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07409298.

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 13 Feb 2026.

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