Developing and Testing the Efficacy of AI-Chatbot-Based
2026년 8월 25일 업데이트: 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.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
68
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Fei-Hsiu FH Hsiao, PhD
- 전화번호: +886918153569
- 이메일: hsiaofei@ntu.edu.tw
연구 장소
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Taipei
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Taipei, Taipei, 대만, 10051
- National Taiwan University
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연락하다:
- Fei-Hsiu Hsiao, PhD
- 전화번호: +886918153569
- 이메일: hsiaofei@ntu.edu.tw
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Patient Health Questionnaire-9, PHQ-9
기간: 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
기간: 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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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Emotion Regulation Questionnaire
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Fei-Hsiu FH Hsiao, PhD, National Taiwan University
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2027년 8월 1일
기본 완료 (추정된)
기본 완료
2032년 7월 31일
연구 완료 (추정된)
연구 완료
2032년 7월 31일
연구 등록 날짜
최초 제출
최초 제출
2026년 8월 12일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 8월 25일
처음 게시됨 (실제)
처음 게시됨
2026년 8월 27일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 8월 27일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 25일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 202604050RINE
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Patient Privacy
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .