AI-Assisted Patient Support in mHSPC (LUMINOUS)
2026年9月1日 更新者：Bo Dai、Fudan University
Effects of Large LangUage Model-Based AI Agent-Assisted Patient-Centered Support on ANxiety, Illness PerceptiOn, and Sleep QUality in Patients With Newly Diagnosed Metastatic Hormone-Sensitive Prostate Cancer: A Multicenter, Open-Label, Randomized Controlled Trial
The purpose of this multicenter, open-label, randomized controlled trial is to evaluate whether patient-centered support delivered through a large language model (LLM)-based artificial intelligence (AI) agent reduces anxiety in patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC).
Participants access the AI agent through a WeChat Mini Program-based platform.
The study will also assess the effects of this intervention on illness perception, sleep quality, and patient satisfaction.
Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group.
Participants in the intervention group will have access to the AI agent-enabled patient support platform throughout the 4-week study period.
Participants in the control group will use the same platform without access to the AI agent during the first 2 weeks and will then receive access to the AI agent for the subsequent 2 weeks.
Both groups will receive standard-of-care medical treatment throughout the study.
The primary objective is to compare changes from baseline in anxiety at 2 weeks between the two groups.
Anxiety will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale.
Secondary outcomes include illness perception, sleep quality, and patient satisfaction.
Exploratory outcomes include the change from baseline in the GAD-7 total score at 4 weeks and the accuracy of responses generated by the AI agent to participants' questions.
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (估计的)
160
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Bo Dai, MD
- 电话号码：+86-21 64175590
- 邮箱：bodai1978@126.com
学习地点
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Fujian
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Fuzhou、Fujian、中国、350011
- Fujian Cancer Hospital
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接触：
- Shushang Chen, MD
- 电话号码：+86 15859198855
- 邮箱：121257401@qq.com
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Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200032
- Fudan University Shanghai Cancer Center
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接触：
- Dai Bo, MD
- 电话号码：+86-21 64175590
- 邮箱：bodai1978@126.com
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Yunnan
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Kunming、Yunnan、中国
- Yunnan Cancer Hospital
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接触：
- Yong Yang
- 电话号码：+86-0871 68185656
- 邮箱：yongy1974@163.com
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Zhejiang
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Wenzhou、Zhejiang、中国、325000
- The First Affiliated Hospital of Wenzhou Medical University
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接触：
- Wei Chen, MD
- 电话号码：+86 15000238255
- 邮箱：2818777033@qq.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Newly diagnosed prostate adenocarcinoma confirmed by histopathology or cytopathology;
- Metastatic disease confirmed by imaging or pathology;
- Diagnosis of metastatic prostate cancer within 2 weeks before enrollment;
- Aged 18-80 years;
- A GAD-7 score of 5 or higher at screening;
- Adequate cognitive ability to understand and participate in the study;
- Adequate language comprehension and ability to complete the study questionnaires independently;
- Access to a smartphone and an internet connection required to use the study platform;
- Provision of written informed consent.
Exclusion Criteria:
- An acute or unstable psychiatric disorder, such as severe depressive or anxiety disorder, or severe insomnia requiring urgent specialist care;
- History of or current cognitive impairment, such as intellectual disability or Alzheimer's disease;
- A requirement for emergency surgery within 72 hours after enrollment;
- Planned prostate cancer-directed radiotherapy, surgery, or chemotherapy during the study period;
- Current participation in another interventional clinical trial;
- A request from the participant's family to withhold the diagnosis or disease-related information from the participant.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Immediate AI Agent Access
Participants will receive immediate access to the AI Agent for 4 weeks after randomization, in addition to standard-of-care medical treatment.
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Participants access the AI agent through a WeChat Mini Program.
It provides clinician-reviewed educational materials on prostate cancer and disease management.
A large language model-based AI agent provides real-time, multi-turn, personalized responses to participants' questions.
Retrieval-augmented generation based on a curated clinical knowledge base is used to improve the accuracy and clinical relevance of the responses.
The AI agent will not replace physician assessment, diagnosis, or treatment decision-making.
Participants will continue to receive standard-of-care medical treatment for mHSPC throughout the study.
Treatment may include androgen deprivation therapy (ADT) in combination with an androgen receptor pathway inhibitor (ARPi), and bone-protective agents may also be administered, as determined by the treating physician according to clinical guidelines and individual patient needs.
However, radiotherapy, surgery, or chemotherapy in any form is not permitted during the study period.
Non-antineoplastic medications taken prior to enrollment may be continued during the study.
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有源比较器：Delayed AI Agent Access
Participants will use the same platform without access to the AI agent during the first 2 weeks after randomization, in addition to standard-of-care medical treatment.
After completing the 2-week assessments, participants will receive access to the AI agent for the remaining 2 weeks.
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Participants will continue to receive standard-of-care medical treatment for mHSPC throughout the study.
Treatment may include androgen deprivation therapy (ADT) in combination with an androgen receptor pathway inhibitor (ARPi), and bone-protective agents may also be administered, as determined by the treating physician according to clinical guidelines and individual patient needs.
However, radiotherapy, surgery, or chemotherapy in any form is not permitted during the study period.
Non-antineoplastic medications taken prior to enrollment may be continued during the study.
The basic platform supports study registration, assessments, and usage tracking but does not provide AI agent function during the first 2 weeks.
Participants will receive access of AI agent after completing the 2-week assessments.
The AI agent is accessible through a WeChat Mini Program.
It provides clinician-reviewed educational materials on prostate cancer and disease management.
A large language model-based AI agent provides real-time, multi-turn, personalized responses to participants' questions.
Retrieval-augmented generation based on a curated clinical knowledge base is used to improve the accuracy and clinical relevance of the responses.
The AI agent will not replace physician assessment, diagnosis, or treatment decision-making.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Between-Group Difference in Change from Baseline in GAD-7 Total Score at 2 Weeks
大体时间：At baseline and 2 weeks after randomization.
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The Generalized Anxiety Disorder-7 (GAD-7) scale assesses anxiety symptoms using 7 items, each scored from 0 to 3. The total score ranges from 0 to 21, with higher scores indicating greater anxiety severity.
Change from baseline is calculated as the score at 2 weeks minus the baseline score, with a negative change indicating improvement.
The mean change from baseline will be compared between the two groups.
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At baseline and 2 weeks after randomization.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Between-Group Difference in Disease Knowledge Test Total Score at 2 Weeks
大体时间：At 2 weeks after randomization.
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The study-specific Disease Knowledge Test consists of 10 objective questions on mHSPC.
Each correct answer is scored as 1, and each incorrect or unknown answer is scored as 0. The total score ranges from 0 to 10, with higher scores indicating greater disease knowledge.
The mean total score at 2 weeks will be compared between the two groups.
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At 2 weeks after randomization.
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Between-Group Difference in Change from Baseline in the Brief Illness Perception Questionnaire (B-IPQ) Total Score at 2 Weeks
大体时间：At baseline and 2 weeks after randomization.
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The Brief Illness Perception Questionnaire (B-IPQ) assesses cognitive and emotional representations of illness.
Eight scored items are rated from 0 to 10.
After appropriate reverse scoring, the total score ranges from 0 to 80, with higher scores indicating a more threatening perception of the illness.
Change from baseline is calculated as the score at 2 weeks minus the baseline score, with negative values indicating improvement.
The mean change from baseline will be compared between the two groups.
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At baseline and 2 weeks after randomization.
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Between-Group Difference in Change from Baseline in the Insomnia Severity Index (ISI) Total Score at 2 Weeks
大体时间：At baseline and 2 weeks after randomization.
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The Insomnia Severity Index (ISI) assesses insomnia severity using 7 items, each scored from 0 to 4. The total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.
Change from baseline is calculated as the score at 2 weeks minus the baseline score, with negative values indicating improvement.
The mean change from baseline will be compared between the two groups.
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At baseline and 2 weeks after randomization.
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Between-Group Difference in Change from Baseline in the Patient Satisfaction Questionnaire-18 (PSQ-18) Score at 2 Weeks
大体时间：At baseline and 2 weeks after randomization.
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The Patient Satisfaction Questionnaire-18 (PSQ-18) consists of 18 items assessing satisfaction with medical care across seven domains.
Each item is scored from 1 to 5.
After appropriate reverse scoring, the item scores are summed to produce a total score ranging from 18 to 90, with higher scores indicating greater patient satisfaction.
Change from baseline is calculated as the score at 2 weeks minus the baseline score, with positive values indicating improvement.
The mean change from baseline will be compared between the two groups.
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At baseline and 2 weeks after randomization.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Between-Group Difference in Change from Baseline in GAD-7 Total Score at 4 Weeks
大体时间：At baseline and 4 weeks after randomization.
|
The Generalized Anxiety Disorder-7 (GAD-7) scale assesses anxiety symptoms using 7 items, each scored from 0 to 3. The total score ranges from 0 to 21, with higher scores indicating greater anxiety severity.
Change from baseline is calculated as the score at 4 weeks minus the baseline score, with a negative change indicating improvement.
The mean change from baseline will be compared between the two groups.
This exploratory comparison reflects the effects of the two access strategies.
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At baseline and 4 weeks after randomization.
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Accuracy of LLM-Generated Answers to Participant Questions
大体时间：During the 4-week study period.
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Participant questions and the corresponding answers generated by the LLM-based AI agent will be collected.
Each answer will be independently reviewed for accuracy by two urologic oncology physicians.
In cases of disagreement, a third urologic oncology expert will make the final determination.
Accuracy will be calculated as the proportion of evaluable answers classified as accurate.
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During the 4-week study period.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2027年2月1日
研究完成 (估计的)
2027年3月1日
研究注册日期
首次提交
2026年9月1日
首先提交符合 QC 标准的
2026年9月1日
首次发布 (实际的)
2026年9月4日
研究记录更新
最后更新发布 (实际的)
2026年9月4日
上次提交的符合 QC 标准的更新
2026年9月1日
最后验证
2026年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.