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NCT Number: NCT07804030

AI-Assisted Patient Support in mHSPC

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.

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Key information

Conditions

Metastatic Prostate Cancer Anxiety Disorders Behavior Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Health Behavior Male Urogenital Diseases Mental Disorders Neoplasms Neoplasms by Site Patient Satisfaction Prostatic Diseases Prostatic Neoplasms Treatment Adherence and Compliance Urogenital Diseases Urogenital Neoplasms

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Fujian Cancer Hospital, Fuzhou, Fujian, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Same Platform without AI Agent

Behavioral

The basic platform supports study registration, assessments, and usage tracking but does not provide AI agent function during the first 2 weeks.

AI Agent-Assisted Patient-Centered Support

Behavioral

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.

Delayed AI Agent-Assisted Patient-Centered Support

Behavioral

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.

Standard-of-care medical treatment

Drug

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.

Primary outcomes

  1. Between-Group Difference in Change from Baseline in GAD-7 Total Score at 2 Weeks

    Time frame: 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.

Secondary outcomes

  1. Between-Group Difference in Disease Knowledge Test Total Score at 2 Weeks

    Time frame: 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.

  2. Between-Group Difference in Change from Baseline in the Brief Illness Perception Questionnaire (B-IPQ) Total Score at 2 Weeks

    Time frame: 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.

  3. Between-Group Difference in Change from Baseline in the Insomnia Severity Index (ISI) Total Score at 2 Weeks

    Time frame: 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.

  4. Between-Group Difference in Change from Baseline in the Patient Satisfaction Questionnaire-18 (PSQ-18) Score at 2 Weeks

    Time frame: 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.

Other outcomes

  1. Between-Group Difference in Change from Baseline in GAD-7 Total Score at 4 Weeks

    Time frame: 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.

  2. Accuracy of LLM-Generated Answers to Participant Questions

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bo Dai, MD

CONTACT

[email protected]

+86-21 64175590

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Acronym: LUMINOUS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 4, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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