Developing and Testing the Efficacy of AI-Chatbot-Based
Developing and Testing the Efficacy of AI-Chatbot-Based Delivering Body-Mind- Spirit Integrated With Mindfulness Compassion Therapy in Improving Holistic Well-being and Depression for Breast Cancer Survivors: A Large-scale Multi-sites Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Fei-Hsiu FH Hsiao, PhD
- Número de teléfono: +886918153569
- Correo electrónico: hsiaofei@ntu.edu.tw
Ubicaciones de estudio
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Taipei
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Taipei, Taipei, Taiwán, 10051
- National Taiwan University
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Contacto:
- Fei-Hsiu Hsiao, PhD
- Número de teléfono: +886918153569
- Correo electrónico: hsiaofei@ntu.edu.tw
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Diagnosis of breast cancer completing the active cancer treatments (surgery, chemotherapy, radiotherapy) Aged at least 20 Owned a smartphone (Android or iOS) with Line access Ability to communicate with the AI chatbot Willingness to participate in the research and interact with the AI-chatbot during the intervention.
Exclusion Criteria:
Diagnosis of another type of cancer Current receipt of psychotherapy Another online psychosocial or mental health intervention The presence of cognitive impairment or severe mental health conditions
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: experimental group
AIAI-Chatbot CalmMindRecoveryJourney delivering BMS-MC therapy
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CalmRecoveryJourney is a rule-based AI-Chatbot implemented through Line platform which guides survivors step by step complete 6-week Modules: BMS empowerment strategies, Structured Mindfulness skills and Compassion-based skills.
The modules for each session contents will be developed based on our previous intervention studies on BMS-MC for breast cancer survivors, lung cancer survivors and their caregivers (Hsiao et al., 2012; Hsiao et al., 2016; Hsiao et al., 2022; Hsiao et al., 2025a; Hsiao et al.,2025b), and update literature review.
BMS-MC consists of BMS empowerment strategies and mindfulness/compassion to enhance breast cancer survivors' holistic well-being and emotional regulation skills (mindfulness, self-compassion).
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Comparador activo: waitlist control group
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CalmRecoveryJourney is a rule-based AI-Chatbot implemented through Line platform which guides survivors step by step complete 6-week Modules: BMS empowerment strategies, Structured Mindfulness skills and Compassion-based skills.
The modules for each session contents will be developed based on our previous intervention studies on BMS-MC for breast cancer survivors, lung cancer survivors and their caregivers (Hsiao et al., 2012; Hsiao et al., 2016; Hsiao et al., 2022; Hsiao et al., 2025a; Hsiao et al.,2025b), and update literature review.
BMS-MC consists of BMS empowerment strategies and mindfulness/compassion to enhance breast cancer survivors' holistic well-being and emotional regulation skills (mindfulness, self-compassion).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Patient Health Questionnaire-9, PHQ-9
Periodo de tiempo: Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3)
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Unabbreviated Scale Title: Patient Health Questionnaire-9 Minimum and Maximum Values: 0 to 27 Outcome Direction: Higher scores indicate a worse outcome (greater severity of depressive symptoms). |
Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3)
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WHO Well-Being Index
Periodo de tiempo: Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3).
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Unabbreviated Scale Title: World Health Organization-Five Well-Being Index Minimum and Maximum Values: 0 to 25 (often converted to a percentage score from 0 to 100 by multiplying the raw score by 4) Outcome Direction: Higher scores indicate a better outcome (higher level of well-being). |
Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Emotion Regulation Questionnaire
Periodo de tiempo: Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3)
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Unabbreviated Scale Title: Emotion Regulation Questionnaire Minimum and Maximum Values: Cognitive Reappraisal Subscale: 6 to 42 Expressive Suppression Subscale: 4 to 28 Outcome Direction: Higher scores indicate greater endorsement/use of that specific emotion regulation strategy. Whether higher scores mean a better or worse outcome depends on context, though Cognitive Reappraisal is generally considered adaptive (better outcome) and Expressive Suppression is often associated with maladaptive outcomes (worse outcome). |
Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3)
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Five Facet Mindfulness Questionnaire
Periodo de tiempo: Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3).
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Unabbreviated Scale Title: Five Facet Mindfulness Questionnaire (15-item short form) Minimum and Maximum Values: 15 to 75 total score (or 3 to 15 for each of the 5 individual subscales) Outcome Direction: Higher scores indicate a better outcome (higher overall level of mindfulness). |
Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3).
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self-compassion scale
Periodo de tiempo: Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3).
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Unabbreviated Scale Title: Self-Compassion Scale (or Self-Compassion Scale - Short Form) Minimum and Maximum Values: 1 to 5 mean score (calculated by averaging item scores) Outcome Direction: Higher scores indicate a better outcome (higher level of self-compassion). |
Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3).
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EORTC QLQ-BR45
Periodo de tiempo: Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3)
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Unabbreviated Scale Title: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer Module (45 items) Minimum and Maximum Values: Raw scores are transformed linearly into a standardized score ranging from 0 to 100 for all subscales. Outcome Direction: Functional Scales / Single Items: Higher scores indicate a better outcome (a higher/better level of functioning). Symptom Scales / Single Items: Higher scores indicate a worse outcome (a higher level of symptoms or problems). |
Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3)
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wearable EEG power in alpha band
Periodo de tiempo: Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3)
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wearable EEG power in alpha band
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Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Fei-Hsiu FH Hsiao, PhD, National Taiwan University
Publicaciones y enlaces útiles
Publicaciones Generales
- Abd-Alrazaq, A. A., Rababeh, A., Alajlani, M., Bewick, B. M., & Househ, M. (2020). Effectiveness and safety of using chatbots to improve mental health: Systematic review and meta-analysis. Journal of Medical Internet Research, 22(7), e16021. https://doi.org/10.2196/16021 Boie, S. D., Glastetter, E., Lux, M. P., Balzer, F., von Kalle, C., Lenz, C., & Müller, U. (2025). Evaluating a chatbot as a companion for patients with breast cancer: Collaborative pilot study. JMIR Cancer, 11, e68426. Brown, T., Cruickshank, S., & Noblet, M. (2021). Specialist breast care nurses for support of women with breast cancer. The Cochrane Database of Systematic Reviews, 2(2), CD005634. https://doi.org/10.1002/14651858.CD005634.pub3 Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77-101. https://doi.org/10.1191/1478088706qp063oa Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. Dec 1983;24(4):385. Bornemann B, Singer T. Taking time to feel our body: steady increases in heartbeat perception accuracy and decreases in alexithymia over 9 months of contemplative mental training. Psychophysiology. Mar 2017;54(3):469-482. Chakraborty, C., Pal, S., Bhattacharya, M., Dash, S., & Lee, S.-S. (2023). Overview of chatbots with special emphasis on artificial intelligence-enabled ChatGPT in medical science. Frontiers in Artificial Intelligence, 6. Conţ, M., Ciupe, A., Orza, B., Cohuţ, I., & Niţu, G. (2022). Career counseling chatbot using Microsoft bot frameworks. In I. Kallel, H. Kammoun, & L. Hsairi (Eds.), 2022 IEEE Global Engineering Education Conference (EDUCON) (pp. 1387-1392). IEEE. Duan, W., Klibert, J., Schotanus-Dijkstra, M., Llorens, S., van den Heuvel, M., Mayer, C. H., Tomasulo, D., Liao, Y., & van Zyl, L. E. (2022). Editorial: Positive psychological interventions: How, when and why they work: Beyond WEIRD contexts. Frontiers in Psychology, 13, 1021539. https://doi.org/10.3389/fpsyg
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Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 202604050RINE
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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