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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Guanhua Jiang, master degree
- Numer telefonu: 086+15083397959
- E-mail: 1226650459@qq.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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 |
|
Brak interwencji: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
EORTC-QLQ-C30
Ramy czasowe: From enrollment through 6 months after the intervention
|
From enrollment through 6 months after the intervention
|
|
EORTC-QLQ-BR23
Ramy czasowe: From enrollment through 6 months after the intervention
|
From enrollment through 6 months after the intervention
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
|
Self-Rating Anxiety Scale, SAS
Ramy czasowe: From enrollment through 6 months after the intervention
|
From enrollment through 6 months after the intervention
|
|
Self-Rating Depression Scale, SDS
Ramy czasowe: From enrollment through 6 months after the intervention
|
From enrollment through 6 months after the intervention
|
|
General Self-Efficacy Scale, GSES
Ramy czasowe: From enrollment through 6 months after the intervention
|
From enrollment through 6 months after the intervention
|
|
Self-Health Management Ability Scale, SHMAS
Ramy czasowe: From enrollment through 6 months after the intervention
|
From enrollment through 6 months after the intervention
|
|
eHealth Literacy Scale, eHEALS
Ramy czasowe: From enrollment through 6 months after the intervention
|
From enrollment through 6 months after the intervention
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- KY-2026-158
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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