- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07719062
AI Chatbot for Prostate Radiation Therapy Patient Education
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: AI Chatbot Educational Intervention
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.
|
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change in PROMIS Self-Efficacy for Managing Symptoms Score
Tijdsspanne: 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.
|
Baseline before chatbot interaction to immediately after chatbot interaction during the same study session
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 26-198
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .