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Developing and Testing the Efficacy of AI-Chatbot-Based

25 agosto 2026 aggiornato da: National Taiwan University Clinical Trial Center, National Taiwan University Hospital

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

this study aims to develop the Calm-Mind-Recovery-Journey AI-Chatbot delivering BMS-MC therapy for breast cancer survivors and examine its feasibility, acceptability, safety, and preliminary effects of holistic well-being and depressive levels, and coping skills (mindfulness status, self-compassion, emotional regulations), and breast cancer-specific QOL. The experiences of participants using AI-Chatbot will be explored.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

For the first and the second years, Phase I using retrieval-augmented generation (RAG), developing a rule-based "CalmRecoveryJourney" AI-Chatbot step to step guided BMS-MC, feedback system, 24-hour emotional support with human-loop escalation. Phase II Pilot evaluation using a mixed-methods design including the quantitative (a randomized waitlist-controlled trial, RCT) and qualitative methods (in-depth interview) in the 68 breast cancer survivors who completed active cancer treatments and will be recruited from breast cancer organizations, and social media. For the third year, a large-scale single-arm intervention with three repeated measurements (baseline, post-intervention, and follow-up) will be conducted across four geographic regions in Taiwan (North, Central, South, and East). A total of 200 breast cancer survivors from four regions will be recruited. The outcome measures include self-report questionnaires (WHO Well-Being Index and Patient Health Questionnaire-9, PHQ-9, Emotion Regulation Questionnaire, Five Facet Mindfulness Questionnaire, self-compassion scale, EORTC QLQ-BR45, wearable EEG online data and survivors' learning process data from the AI-Chabot system including adherence and engagement with AI-Chatbot. Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3). With intentional-to-treat GEE analysis and thematic qualitative analysis will be conducted.

Tipo di studio

Interventistico

Iscrizione (Stimato)

68

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Taipei
      • Taipei, Taipei, Taiwan, 10051
        • National Taiwan University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: experimental group
AIAI-Chatbot CalmMindRecoveryJourney delivering BMS-MC therapy
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).
Comparatore attivo: waitlist control group
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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient Health Questionnaire-9, PHQ-9
Lasso di tempo: Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3)

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)
WHO Well-Being Index
Lasso di tempo: Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3).

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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Emotion Regulation Questionnaire
Lasso di tempo: Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3)

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)
Five Facet Mindfulness Questionnaire
Lasso di tempo: Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3).

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).
self-compassion scale
Lasso di tempo: Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3).

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).
EORTC QLQ-BR45
Lasso di tempo: Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3)

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)
wearable EEG power in alpha band
Lasso di tempo: Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3)
wearable EEG power in alpha band
Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Fei-Hsiu FH Hsiao, PhD, National Taiwan University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

  • 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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2027

Completamento primario (Stimato)

31 luglio 2032

Completamento dello studio (Stimato)

31 luglio 2032

Date di iscrizione allo studio

Primo inviato

12 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

25 agosto 2026

Primo Inserito (Effettivo)

27 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 202604050RINE

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Patient Privacy

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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