AI-Assisted Patient Support in mHSPC (LUMINOUS)

September 1, 2026 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: 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.
Drug: 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.
Active Comparator: 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.
Drug: 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.
Behavioral: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At baseline and 2 weeks after randomization.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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.
At baseline and 2 weeks after randomization.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At baseline and 4 weeks after randomization.
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.
During the 4-week study period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PCaAICom-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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