Prostate Cancer PatientsNCT07719062
AI Chatbot for Prostate Radiation Therapy Patient Education
A study testing AI Educational Chatbot in people with Prostate Cancer Patients, run by Brigham and Women's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer Patients
- What is being tested?
- AI Educational Chatbot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Aug 2027
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Adults unable to consent independently
- Individuals who are not yet adults
- Prisoners
About this study
Official title: Clinical Evaluation of Large Language Model (LLM) Methods to Support Prostate Cancer Radiation Therapy Patient Education
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.
- Conditions
- Prostate Cancer Patients
- Being tested
- AI Educational Chatbot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI Educational ChatbotOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: AI Educational Chatbot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PROMIS Self-Efficacy for Managing Symptoms Score
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.
Measured: Baseline before chatbot interaction to immediately after chatbot interaction during the same study session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study startDec 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond Mak, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719062
- Sponsor's protocol ID
- 26-198
- Status last verified
- Jun 2026
- First submitted
- 17 Jul 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Large Language Model (LLM) Methods to Support Prostate Cancer Radiation Therapy Patient Education
- ClinicalTrials.gov ID
- NCT07719062
- Acronym / sponsor ID
- 26-198
- Conditions
- Prostate Cancer Patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AI Chatbot Educational Intervention | Experimental | Other: AI Educational ChatbotParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Adults unable to consent independently
- Individuals who are not yet adults
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI Educational ChatbotParticipants 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. | Other | AI Chatbot Educational Intervention |
Primary outcome
Change in PROMIS Self-Efficacy for Managing Symptoms Score
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing AI Educational Chatbot in people with Prostate Cancer Patients, run by Brigham and Women's Hospital.
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 5 inclusion and 3 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PROMIS Self-Efficacy for Managing Symptoms Score (time frame: Baseline before chatbot interaction to immediately after chatbot interaction during the same study session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026.