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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Guanhua Jiang, master degree
- Telefonní číslo: 086+15083397959
- E-mail: 1226650459@qq.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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 |
|
Žádný zásah: 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
EORTC-QLQ-C30
Časové okno: From enrollment through 6 months after the intervention
|
From enrollment through 6 months after the intervention
|
|
EORTC-QLQ-BR23
Časové okno: From enrollment through 6 months after the intervention
|
From enrollment through 6 months after the intervention
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Self-Rating Anxiety Scale, SAS
Časové okno: From enrollment through 6 months after the intervention
|
From enrollment through 6 months after the intervention
|
|
Self-Rating Depression Scale, SDS
Časové okno: From enrollment through 6 months after the intervention
|
From enrollment through 6 months after the intervention
|
|
General Self-Efficacy Scale, GSES
Časové okno: From enrollment through 6 months after the intervention
|
From enrollment through 6 months after the intervention
|
|
Self-Health Management Ability Scale, SHMAS
Časové okno: From enrollment through 6 months after the intervention
|
From enrollment through 6 months after the intervention
|
|
eHealth Literacy Scale, eHEALS
Časové okno: From enrollment through 6 months after the intervention
|
From enrollment through 6 months after the intervention
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- KY-2026-158
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