The Impact of Artificial Intelligence-Based Health Intervention (AI-HEALS), Based on Symptom Management Theory, on Quality of Life and Related Outcomes in Postoperative Breast Cancer Patients

November 8, 2026 updated by: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

The objective of this clinical trial is to determine whether the AI-HEALS artificial intelligence-based mobile health intervention, grounded in symptom management theory, can improve health outcomes for adult women who have undergone surgery for Stage I-III breast cancer and are receiving adjuvant therapy. The primary research questions it aims to address are:

Can the AI-HEALS intervention improve the quality of life for patients who have undergone breast cancer surgery? Can the AI-HEALS intervention improve patients' levels of anxiety and depression, self-efficacy, self-health management abilities, and e-health literacy?

Researchers will compare patients receiving the AI-HEALS intervention with those receiving standard of care to determine the effect of the AI-HEALS intervention on relevant health outcomes for patients who have undergone breast cancer surgery.

Participants will:

  • Intervention Group: In addition to standard care, receive a 6-month, phased AI-HEALS artificial intelligence health intervention via WeChat, including daily symptom logging, personalized health content push notifications, completion of various online questionnaires, and participation in online follow-ups;
  • Control Group: Receive standard post-surgical care for breast cancer, paper-based and general WeChat health education, and telephone follow-ups at fixed time points;
  • All participants are required to complete questionnaires assessing quality of life, psychological well-being, and other relevant factors at baseline, 3 months into the intervention, and at the end of the 6-month intervention period.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Guanhua Jiang, master degree
  • Phone Number: 086+15083397959
  • Email: 1226650459@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age ≥ 18 years; patients with clinically and pathologically diagnosed Stage I-III breast cancer who have undergone surgery and received adjuvant treatments such as chemotherapy; patients who are proficient in using a smartphone and regularly use WeChat, so they can successfully receive and participate in the WeChat-based intervention program; patients who are willing to participate in the study and sign an informed consent form before the study begins.

Exclusion Criteria:

  • If participants cannot be reached by phone or WeChat during the study, or if no family members can be contacted; if participants are taking any psychiatric medications; if participants exhibit psychiatric symptoms during the study, such as confusion, difficulty speaking, or lack of cooperation; if participants have a serious systemic disease or severe physical dysfunction; or if participants are enrolled in other clinical trials. Any other reasons deemed to make participation inappropriate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study Group

In addition to standard care, the intervention group received a 6-month AI-HEALS WeChat platform intervention based on symptom management theory, which implemented a closed-loop management process of "symptom assessment-personalized intervention-behavioral monitoring-feedback and adjustment" focused on symptom experience, symptom management behaviors, and environmental factors. Platform functionality was configured prior to the intervention; personal health records were established for patients within 24 hours of admission; and training on platform use was provided to both patients and caregivers.
Behavioral: AI-Based Health Interventions

This intervention integrates Symptom Management Theory (SMT) with WeChat-based artificial intelligence mobile health technology to establish a closed-loop management process comprising "symptom assessment-personalized intervention-behavioral monitoring-feedback and adjustment." This study employs a phased intervention strategy comprising the acute inpatient phase, the subacute home-based phase, and the long-term maintenance phase. By integrating natural language processing and reinforcement learning algorithms, the intervention content is dynamically adjusted based on patients' real-time symptom feedback and behavioral responses. Additionally, the involvement of family caregivers is incorporated throughout the entire intervention process to achieve dynamic, individualized, and continuous symptom management, distinguishing it from conventional nursing care and mobile health interventions not empowered by AI
No Intervention: Control Group

The control group received standard postoperative care for breast cancer over a 6-month period: basic care for incisions, drainage tubes, and pain management was provided during the first 1-7 days of hospitalization, along with health education delivered verbally and via printed brochures, basic psychological counseling, and discharge instructions; At 1, 3, and 6 months post-surgery, general health information was sent via WeChat, followed by 10-15-minute telephone follow-ups to assess recovery and medication adherence, answer questions, and remind patients of follow-up appointments; no personalized interventions were provided.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
EORTC-QLQ-C30
Time Frame: From enrollment through 6 months after the intervention
From enrollment through 6 months after the intervention
EORTC-QLQ-BR23
Time Frame: From enrollment through 6 months after the intervention
From enrollment through 6 months after the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Self-Rating Anxiety Scale, SAS
Time Frame: From enrollment through 6 months after the intervention
From enrollment through 6 months after the intervention
Self-Rating Depression Scale, SDS
Time Frame: From enrollment through 6 months after the intervention
From enrollment through 6 months after the intervention
General Self-Efficacy Scale, GSES
Time Frame: From enrollment through 6 months after the intervention
From enrollment through 6 months after the intervention
Self-Health Management Ability Scale, SHMAS
Time Frame: From enrollment through 6 months after the intervention
From enrollment through 6 months after the intervention
eHealth Literacy Scale, eHEALS
Time Frame: From enrollment through 6 months after the intervention
From enrollment through 6 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY-2026-158

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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