NCT07719062

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Aug 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

July 22, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

July 17, 2026

Last Update Submit

July 17, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in PROMIS Self-Efficacy for Managing Symptoms Score

    Baseline before chatbot interaction to immediately after chatbot interaction during the same study session

Study Arms (1)

AI Chatbot Educational Intervention

EXPERIMENTAL

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.

Other: AI Educational Chatbot

Interventions

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.

AI Chatbot Educational Intervention

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Radiation Oncology

Study Record Dates

First Submitted

July 17, 2026

First Posted

July 22, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

July 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share