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AI-Assisted Patient Support in mHSPC (LUMINOUS)

2026년 9월 1일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

160

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
    • Fujian
      • Fuzhou, Fujian, 중국, 350011
        • Fujian Cancer Hospital
        • 연락하다:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, 중국, 200032
        • Fudan University Shanghai Cancer Center
        • 연락하다:
    • Yunnan
      • Kunming, Yunnan, 중국
        • Yunnan Cancer Hospital
        • 연락하다:
    • Zhejiang
      • Wenzhou, Zhejiang, 중국, 325000
        • The First Affiliated Hospital of Wenzhou Medical University
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. Newly diagnosed prostate adenocarcinoma confirmed by histopathology or cytopathology;
  2. Metastatic disease confirmed by imaging or pathology;
  3. Diagnosis of metastatic prostate cancer within 2 weeks before enrollment;
  4. Aged 18-80 years;
  5. A GAD-7 score of 5 or higher at screening;
  6. Adequate cognitive ability to understand and participate in the study;
  7. Adequate language comprehension and ability to complete the study questionnaires independently;
  8. Access to a smartphone and an internet connection required to use the study platform;
  9. Provision of written informed consent.

Exclusion Criteria:

  1. An acute or unstable psychiatric disorder, such as severe depressive or anxiety disorder, or severe insomnia requiring urgent specialist care;
  2. History of or current cognitive impairment, such as intellectual disability or Alzheimer's disease;
  3. A requirement for emergency surgery within 72 hours after enrollment;
  4. Planned prostate cancer-directed radiotherapy, surgery, or chemotherapy during the study period;
  5. Current participation in another interventional clinical trial;
  6. A request from the participant's family to withhold the diagnosis or disease-related information from the participant.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
행동: AI Agent-Assisted Patient-Centered Support
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.
의약품: Standard-of-Care Medical Treatment
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.
활성 비교기: 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.
의약품: Standard-of-Care Medical Treatment
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.
행동: The Same Platform without AI Agent
The basic platform supports study registration, assessments, and usage tracking but does not provide AI agent function during the first 2 weeks.
행동: Delayed AI Agent-Assisted Patient-Centered Support
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Between-Group Difference in Change from Baseline in GAD-7 Total Score at 2 Weeks
기간: At baseline and 2 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 2 weeks minus the baseline score, with a negative change indicating improvement. The mean change from baseline will be compared between the two groups.
At baseline and 2 weeks after randomization.

2차 결과 측정

결과 측정
측정값 설명
기간
Between-Group Difference in Disease Knowledge Test Total Score at 2 Weeks
기간: At 2 weeks after randomization.
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.
At 2 weeks after randomization.
Between-Group Difference in Change from Baseline in the Brief Illness Perception Questionnaire (B-IPQ) Total Score at 2 Weeks
기간: At baseline and 2 weeks after randomization.
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.
At baseline and 2 weeks after randomization.
Between-Group Difference in Change from Baseline in the Insomnia Severity Index (ISI) Total Score at 2 Weeks
기간: At baseline and 2 weeks after randomization.
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.
At baseline and 2 weeks after randomization.
Between-Group Difference in Change from Baseline in the Patient Satisfaction Questionnaire-18 (PSQ-18) Score at 2 Weeks
기간: At baseline and 2 weeks after randomization.
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.
At baseline and 2 weeks after randomization.

기타 결과 측정

결과 측정
측정값 설명
기간
Between-Group Difference in Change from Baseline in GAD-7 Total Score at 4 Weeks
기간: 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.
At baseline and 4 weeks after randomization.
Accuracy of LLM-Generated Answers to Participant Questions
기간: During the 4-week study period.
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.
During the 4-week study period.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Fudan University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2027년 2월 1일

연구 완료 (추정된)

2027년 3월 1일

연구 등록 날짜

최초 제출

2026년 9월 1일

QC 기준을 충족하는 최초 제출

2026년 9월 1일

처음 게시됨 (실제)

2026년 9월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 1일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • PCaAICom-01

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다