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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in PROMIS Self-Efficacy for Managing Symptoms Score
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 26-198
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。