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Breast CancerNCT07791368

Developing and Testing the Efficacy of AI-Chatbot-Based

A study testing AIAI-Chatbot CalmMindRecoveryJourney delivering BMS-MC therapy in people with Breast Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
AIAI-Chatbot CalmMindRecoveryJourney delivering BMS-MC therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteTaiwan
Study dates
1 Aug 2027to 31 Jul 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fei-Hsiu FH Hsiao, PhD contact

+886918153569

hsiaofei@ntu.edu.tw

Taiwan1 site

  • National Taiwan University

    Taipei, Taipei, 10051

    Fei-Hsiu Hsiao, PhD, +886918153569, hsiaofei@ntu.edu.tw

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Conditions
Breast Cancer
Being tested
AIAI-Chatbot CalmMindRecoveryJourney delivering BMS-MC therapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AIAI-Chatbot CalmMindRecoveryJourney delivering BMS-MC therapyBehavioural

    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).

Study groups in NCT07791368
Study groupRoleWhat they receive
experimental groupExperimentalAIAI-Chatbot CalmMindRecoveryJourney delivering BMS-MC therapy
Receives: Behavioral: AIAI-Chatbot CalmMindRecoveryJourney delivering BMS-MC therapy
waitlist control groupActive comparatorwaitlist control group
Receives: Behavioral: AIAI-Chatbot CalmMindRecoveryJourney delivering BMS-MC therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3)

  2. 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).

    Measured: 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)

  1. Emotion Regulation Questionnaire

    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).

    Measured: Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3)

  2. Five Facet Mindfulness Questionnaire

    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).

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

  3. self-compassion scale

    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).

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

  4. EORTC QLQ-BR45

    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).

    Measured: Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3)

  5. wearable EEG power in alpha band

    wearable EEG power in alpha band

    Measured: Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2026
  2. Study start1 Aug 2027 (estimated)
  3. Primary completion31 Jul 2032 (estimated)
  4. Study completion31 Jul 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07791368
Sponsor's protocol ID
202604050RINE
Status last verified
Aug 2026
First submitted
12 Aug 2026
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Patient Privacy

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing AIAI-Chatbot CalmMindRecoveryJourney delivering BMS-MC therapy in people with Breast Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fei-Hsiu FH Hsiao, PhD (+886918153569, hsiaofei@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Health Questionnaire-9, PHQ-9 (time frame: Measurement time-points are at baseline (T1), the 6 week (the end of AI-Chatbot guide) (T2), the 12 week (self-practices period) (T3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07791368, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

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