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AI-Assisted Patient Support in mHSPC (LUMINOUS)

1. september 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

160

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Legemiddel: 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.
Aktiv komparator: 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.
Legemiddel: 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.
Atferdsmessig: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Between-Group Difference in Change from Baseline in GAD-7 Total Score at 2 Weeks
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Between-Group Difference in Disease Knowledge Test Total Score at 2 Weeks
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Between-Group Difference in Change from Baseline in GAD-7 Total Score at 4 Weeks
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Fudan University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. februar 2027

Studiet fullført (Antatt)

1. mars 2027

Datoer for studieregistrering

Først innsendt

1. september 2026

Først innsendt som oppfylte QC-kriteriene

1. september 2026

Først lagt ut (Faktiske)

4. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PCaAICom-01

Plan for individuelle deltakerdata (IPD)

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NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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