NCT07804030

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Sep 2026Mar 2027

First Submitted

Initial submission to the registry

September 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

September 4, 2026

Status Verified

September 1, 2026

Enrollment Period

5 months

First QC Date

September 1, 2026

Last Update Submit

September 1, 2026

Conditions

Metastatic Prostate Cancer

Keywords

Prostate cancerLarge Language ModelAnxietyIllness PerceptionPatient Satisfaction

Outcome Measures

Primary Outcomes (1)

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

    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 Outcomes (4)

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

    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

    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

    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

    At baseline and 2 weeks after randomization.

Other Outcomes (2)

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

    At baseline and 4 weeks after randomization.

  • Accuracy of LLM-Generated Answers to Participant Questions

    During the 4-week study period.

Study Arms (2)

Immediate AI Agent Access

EXPERIMENTAL

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 SupportDrug: Standard-of-Care Medical Treatment

Delayed AI Agent Access

ACTIVE COMPARATOR

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.

Behavioral: The Same Platform without AI AgentBehavioral: Delayed AI Agent-Assisted Patient-Centered SupportDrug: Standard-of-Care Medical Treatment

Interventions

AI Agent-Assisted Patient-Centered SupportBEHAVIORAL

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.

Immediate AI Agent Access
Delayed AI Agent-Assisted Patient-Centered SupportBEHAVIORAL

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.

Delayed AI Agent Access
Standard-of-Care Medical TreatmentDRUG

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.

Delayed AI Agent AccessImmediate AI Agent Access
The Same Platform without AI AgentBEHAVIORAL

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

Delayed AI Agent Access

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Fujian Cancer Hospital

Fuzhou, Fujian, 350011, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Yunnan Cancer Hospital

Kunming, Yunnan, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Prostatic NeoplasmsAnxiety DisordersPatient Satisfaction

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesMental DisordersTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Bo Dai, MD

CONTACT

+86-21 64175590bodai1978@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 1, 2026

First Posted

September 4, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

September 4, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)