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
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Guanhua Jiang, master degree
- Phone Number: 086+15083397959
- Email: 1226650459@qq.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
Intervention / Treatment |
|---|---|
|
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. |
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
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
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
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY-2026-158
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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