AI Chatbot for Prostate Radiation Therapy Patient Education

NCT07719062 — Not applicable, Not yet recruiting, 50 participants, Brigham and Women's Hospital

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Clinical Evaluation of Large Language Model (LLM) Methods to Support Prostate Cancer Radiation Therapy Patient Education

Registry	NCT07719062
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, supportive care
Enrollment	50 (Estimated)
Sponsor	Brigham and Women's Hospital (Other)
Conditions	Prostate Cancer Patients
Interventions	AI Educational Chatbot (Other)
Dates	start 2026-12-01 (estimated), primary completion 2027-02-01 (estimated), completion 2027-08-01 (estimated), first posted 2026-07-22, last updated 2026-09-17

-Summary

This study will evaluate whether an artificial intelligence chatbot can help patients better understand radiation therapy for localized prostate cancer. Participants will be adults with prostate cancer who are planning definitive radiation therapy at Brigham and Women's Hospital.

All participants will receive standard radiation therapy education and clinician-led discussions as part of routine care. In addition, participants will interact with an educational chatbot about prostate cancer radiation therapy. The chatbot is designed to provide plain-language information about treatment logistics, preparation, possible side effects, follow-up, and when to contact the care team. The chatbot will not provide diagnosis, treatment recommendations, individualized medical advice, or replace conversations with clinicians.

Participants will complete questionnaires before and after using the chatbot. The study will measure changes in patient understanding, confidence in managing symptoms, usability of the chatbot, and safety-related concerns identified during clinician review of chatbot responses.

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+Arms and interventions

Arm	Type	Interventions	Description
AI Chatbot Educational Intervention	Experimental	Other: AI Educational Chatbot	Participants will complete baseline questionnaires, interact with the LLM-based prostate radiation education chatbot, and then complete post-intervention questionnaires. The chatbot is used in addition to standard radiation therapy education and clinician-led discussions.

AI Educational Chatbot (Other): Participants will interact with an LLM-based educational chatbot focused on prostate cancer radiation therapy. The chatbot provides plain-language information about treatment logistics, preparation, expected follow-up, possible urinary, bowel, sexual, and hormonal side effects, symptom monitoring, and when to contact the care team. The chatbot is used as an adjunct to standard radiation therapy education and clinician-led discussions. The chatbot is based on ChatGPT 5.2 deployed within a secure Mass General Brigham Azure environment and configured with physician-reviewed educational source materials and safety guardrails. It is designed to provide educational information only and does not diagnose, recommend treatment choices, provide individualized medical advice, or alter clinical management. Participant interactions will not be used to train, fine-tune, or update the underlying foundation model.

+Outcome measures

Primary outcomes

Change in PROMIS Self-Efficacy for Managing Symptoms Score [Baseline before chatbot interaction to immediately after chatbot interaction during the same study session]: Within-participant change in symptom self-efficacy will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms instrument. Scores are reported as PROMIS T-scores, with a mean of 50 and standard deviation of 10 in the reference population. Higher scores indicate greater confidence in managing symptoms, which is a better outcome. There is no fixed minimum or maximum T-score, although typical PROMIS T-scores generally range from approximately 20 to 80.

+Eligibility

Sex: Male, ages: 18 Years to any

Inclusion Criteria:

* Age 18 years or older
* Current diagnosis of prostate cancer
* Planning to receive definitive prostate cancer radiation therapy at Brigham and Women's Hospital Department of Radiation Oncology
* English-speaking
* Ability to understand and willingness to provide informed consent

Exclusion Criteria:

* Adults unable to consent independently
* Individuals who are not yet adults
* Prisoners