Breast Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAIAI-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).
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-9, PHQ-9 | 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). |
| WHO Well-Being Index | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Emotion Regulation Questionnaire | 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). |
| Five Facet Mindfulness Questionnaire | 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). |
| self-compassion scale | 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). |
| EORTC QLQ-BR45 | 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). |
| 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) | wearable EEG power in alpha band |
Countries
Taiwan
Contacts
CONTACTFei-Hsiu FH Hsiao, PhD
PRINCIPAL_INVESTIGATORFei-Hsiu FH Hsiao, PhD
National Taiwan University
Outcome results
None listed