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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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).
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Xianliang Liu, MD, PhD
- Numero di telefono: (852) 3970 8790
- Email: dxliu@hkmu.edu.hk
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
Altri nomi:
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Nessun intervento: Control Group
Usual care |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Recruitment rate
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Weeks 4 and 12.
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Among intervention-group participants, acceptability and usability will be assessed using the study-specific AIMS feedback questionnaire. |
Weeks 4 and 12.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Traditional Chinese MD Anderson Symptom Inventory Symptom-Severity Score
Lasso di tempo: 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.
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Kessler Psychological Distress Scale 10-Item Total Score
Lasso di tempo: 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.
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Hospital Anxiety and Depression Scale
Lasso di tempo: 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.
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Functional Assessment of Cancer Therapy-Breast
Lasso di tempo: 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.
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Health-services utilization
Lasso di tempo: 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.
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Adverse events associated with AIMS
Lasso di tempo: 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.
|
Collaboratori e investigatori
Collaboratori
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Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HE-RD/2026/1.22
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