UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062716 |
|---|---|
| Receipt number | R000071809 |
| Scientific Title | Peer Supporter-Modeled Generative AI Chatbot for Psychological Support in Patients With Breast Cancer: Single-Arm Feasibility Study |
| Date of disclosure of the study information | 2026/08/28 |
| Last modified on | 2026/08/27 22:08:39 |
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Basic information
Public title
Feasibility Study of a Generative AI Chatbot for Psychological Support in Patients With Breast Cancer
Acronym
Breast Cancer AI Chatbot Study
Scientific Title
Peer Supporter-Modeled Generative AI Chatbot for Psychological Support in Patients With Breast Cancer: Single-Arm Feasibility Study
Scientific Title:Acronym
Peer-BC AI Study
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to prospectively evaluate the feasibility and acceptability of our peer supporter-modeled generative AI chatbot for providing round-the-clock psychological support to patients with primary breast cancer, focusing on system operation and safety, usage patterns and patient needs, satisfaction and acceptability, and the feasibility of longitudinal QOL assessment. We also explored differences across treatment phases to inform the design of a future randomized controlled trial.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome was patient satisfaction after approximately 12 weeks of chatbot use, measured with a two-item study-developed questionnaire: overall satisfaction (4-point scale, 4=very good to 1=very poor) and willingness to recommend the chatbot to family or acquaintances (4-point scale, 4=definitely to 1=definitely not). The sum of the two items formed the satisfaction score (range, 2-8; higher indicates greater satisfaction).
Key secondary outcomes
Secondary outcomes included exploratory assessment of patient needs, QOL, and chatbot acceptability and usage. Patient needs were assessed with a study-developed questionnaire characterizing counseling needs and the current state of psychological support.
QOL was assessed with the Japanese version of the EORTC QLQ-C30 (version 3). QOL was assessed at enrollment (baseline) and at approximately 3, 6, 9, and 12 weeks, allowing evaluation of both the QOL trajectory and the response rate at each time point. Although a peer-support intervention in patients undergoing adjuvant chemotherapy reported QOL improvement or maintenance from baseline to treatment end, its effect on the QOL trajectory during treatment is not well characterized; we therefore evaluated longitudinal QOL change as an exploratory outcome. As this pilot was designed to inform a future RCT, response rate at each time point was also assessed, to evaluate the feasibility of periodic data collection via Google Forms.
A post-use questionnaire assessed perceived burden or discomfort during use and intention to continue, as indicators of acceptability. Chatbot usage was characterized by using the number of sessions, active days, number of user messages, and total character count.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligibility required age>=18 years at consent and the ability to operate a smartphone or internet-connected device.
Key exclusion criteria
Patients with a psychiatric or cognitive impairment precluding QOL assessment, or enrolled in another interventional trial were excluded.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tadahiko |
| Middle name | |
| Last name | Shien |
Organization
Okayama University Hospital
Division name
Department of Breast and Endocrine Surgery
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
086-223-7151
tshien@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Nakamoto |
Organization
Okayama University Hospital
Division name
Department of Breast and Endocrine Surgery
Zip code
700-8558
Address
2-5-1, Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
086-223-7151
Homepage URL
p92c9f20@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Okayama University Hospital
Address
2-5-1, Shikata-cho, Kita-ku, Okayama 700-8558, Japan
Tel
086-235-6938
mae6605@adm.okayama-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
Satisfaction data were obtained from 11 of 20 patients (55%), with a median score of 6 {IQR, 0.5} (range, 4-8). Overall, 70.9% of user messages (611/862) were sent outside standard clinic hours, with usage peaking in the evening. Active days (i.e., days with >=1 chatbot message) (p=0.026) and number of user messages (p=0.015) were significantly correlated with satisfaction. QLQ-C30 Global QOL changed significantly over time (p=0.030), with limited between-group and interaction effects.
Results date posted
| 2026 | Year | 08 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients with primary breast cancer are prospectively enrolled and use a generative AI chatbot modeled on a breast cancer peer supporter for approximately 12 weeks. System operation and safety, chatbot usage, patient needs, satisfaction, and acceptability are assessed. QOL is evaluated using the EORTC QLQ-C30 at enrollment and approximately 3, 6, 9, and 12 weeks after enrollment. Differences across the neoadjuvant chemotherapy, adjuvant chemotherapy, and surgery groups are also explored.
Management information
Registered date
| 2026 | Year | 08 | Month | 27 | Day |
Last modified on
| 2026 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071809
