AI-Based Symptom Management for Post-Treatment Breast Cancer Survivors (AIMS-BC)
Artificial Intelligence-Based Multidimensional Symptom Management (AIMS) Invention to Reduce Symptom Burden and Improve Quality of Life Among Post-Treatment Breast Cancer Survivors: A Pilot Randomized Controlled Trial (AIMS-BC Trial)
This pilot randomized controlled trial will test the feasibility and acceptability of an Artificial Intelligence-based Multidimensional Symptom Management (AIMS) intervention for post-treatment breast cancer survivors. Thirty-six participants will be randomly assigned (1:1) to receive either the AIMS intervention or usual care. Outcomes include feasibility (recruitment and retention), adherence, acceptability, symptom burden, psychological distress, quality of life, and safety of the AIMS intervention.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
The AIMS platform is an AI-enabled digital intervention that provides personalized symptom management support through automated monitoring, tailored recommendations, and interactive communication.
A pilot randomized controlled trial will be conducted. Thirty-six eligible post-treatment breast cancer survivors will be recruited through community organizations. Participants will be randomized into two parallel groups. The intervention group will receive the AIMS application alongside standard survivorship care, while the control group will receive usual care only. Outcome assessments will occur at baseline (T0), four weeks (T1), and twelve weeks (T2).
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Xianliang Liu, MD, PhD
- Numer telefonu: (852) 3970 8790
- E-mail: dxliu@hkmu.edu.hk
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Female breast cancer survivors aged 18 years or older
- Experiencing at least one symptom in the past month (e.g., fatigue, pain and insomnia, a score of ≥2 on the 0-10 Numeric Rating Scale (0 = "no fatigue", 10 = "worst fatigue")
- Completed primary treatment (surgery, chemotherapy, or radiotherapy) within the last 24 months
- Able to read Chinese and use a smartphone or tablet
Exclusion Criteria:
- Unstable medical condition
- Severe psychiatric disorders or cognitive impairment
- Participation in another interventional study
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Intervention Group
Participants will install and use the AIMS application. |
The AIMS intervention is a digital self-management platform that provides personalized symptom monitoring, tailored self-management support, and interactive guidance.
Inne nazwy:
|
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Brak interwencji: Control Group
Usual care |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Recruitment rate
Ramy czasowe: From recruitment commencement until completion of recruitment.
|
Number and percentage of eligible individuals who provide informed consent and are randomized. Recruitment rate will be calculated as: number randomized ÷ number eligible × 100. |
From recruitment commencement until completion of recruitment.
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Participant retention at Week 12
Ramy czasowe: Week 12
|
Number and percentage of randomized participants who complete the Week 12 assessment. Retention will be calculated as: number completing the Week 12 assessment ÷ number randomized × 100. |
Week 12
|
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Adherence to the AIMS intervention
Ramy czasowe: Weekly during Weeks 1-12, summarized at Weeks 4 and 12.
|
Adherence will be assessed using system-generated usage data (e.g., frequency of logins) and supplemented by participant-reported usage logs. |
Weekly during Weeks 1-12, summarized at Weeks 4 and 12.
|
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Acceptability and usability of the AIMS platform
Ramy czasowe: Weeks 4 and 12.
|
Among intervention-group participants, acceptability and usability will be assessed using the study-specific AIMS feedback questionnaire. |
Weeks 4 and 12.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Traditional Chinese MD Anderson Symptom Inventory Symptom-Severity Score
Ramy czasowe: Baseline, Week 4, and Week 12.
|
The Chinese MD Anderson Symptom Inventory symptom-severity scale contains 13 symptoms rated from 0 ("not present") to 10 ("as bad as you can imagine"). The mean symptom-severity score ranges from 0 to 10, with higher scores indicating greater symptom burden. |
Baseline, Week 4, and Week 12.
|
|
Kessler Psychological Distress Scale 10-Item Total Score
Ramy czasowe: Baseline, Week 4, and Week 12.
|
Psychological distress will be measured using the 10-item Kessler Psychological Distress Scale. Total scores range from 10 to 50, with higher scores indicating greater psychological distress. |
Baseline, Week 4, and Week 12.
|
|
Hospital Anxiety and Depression Scale
Ramy czasowe: Baseline, Week 4, and Week 12.
|
Anxiety and depression will be measured using the Hospital Anxiety and Depression Scale. Separate anxiety and depression subscale scores range from 0 to 21; higher scores indicate greater symptom severity. |
Baseline, Week 4, and Week 12.
|
|
Functional Assessment of Cancer Therapy-Breast
Ramy czasowe: Baseline, Week 4, and Week 12.
|
Quality of life will be measured using the 37-item Functional Assessment of Cancer Therapy-Breast, Version 4. The total score ranges from 0 to 148, with higher scores indicating better quality of life. |
Baseline, Week 4, and Week 12.
|
|
Health-services utilization
Ramy czasowe: Baseline, Week 4, and Week 12.
|
Participant-reported use of healthcare services, including the number of relevant outpatient visits, emergency-department visits, and hospital admissions during the specified recall period. Each service category will be reported separately. |
Baseline, Week 4, and Week 12.
|
|
Adverse events associated with AIMS
Ramy czasowe: Continuously from randomization through Week 12.
|
Number and percentage of participants experiencing adverse events or negative experiences considered related to the AIMS intervention, including emotional distress, fatigue, or discomfort associated with platform use. Events will be recorded when reported and summarized by severity and relatedness. |
Continuously from randomization through Week 12.
|
Współpracownicy i badacze
Współpracownicy
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
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- HE-RD/2026/1.22
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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