Developing and Testing the Efficacy of AI-Chatbot-Based

NCT07791368 | Not Yet Recruiting

• 1 other identifier: 202604050RINE
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Patient Health Questionnaire-9, PHQ-9

  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

  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).

Secondary Outcomes (5)

• 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)

• 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).

• 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).

• 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)

• 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)

Study Arms (2)

experimental group

EXPERIMENTAL

AIAI-Chatbot CalmMindRecoveryJourney delivering BMS-MC therapy

Behavioral: AIAI-Chatbot CalmMindRecoveryJourney delivering BMS-MC therapy

waitlist control group

ACTIVE COMPARATOR

waitlist control group

Behavioral: AIAI-Chatbot CalmMindRecoveryJourney delivering BMS-MC therapy

Interventions

AIAI-Chatbot CalmMindRecoveryJourney delivering BMS-MC therapy BEHAVIORAL

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).

experimental group; waitlist control group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: male and female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University

Taipei, Taipei, 10051, Taiwan

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fei-Hsiu FH Hsiao, PhD

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei-Hsiu FH Hsiao, PhD

CONTACT

+886918153569; hsiaofei@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): August 1, 2027
• Primary Completion (Estimated): July 31, 2032
• Study Completion (Estimated): July 31, 2032
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)