AI-Assisted Patient Support in mHSPC

ClinicalTrials.gov ID

NCT07804030

Lead Sponsor

Fudan UniversityOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

160Estimated

Last Update Posted

Sep 4, 2026Actual

Start Date

Sep 2026Estimated

Primary Completion Date

Feb 2027Estimated

Completion Date

Mar 2027Estimated

Official 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

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.

• Metastatic Prostate Cancer

• The Same Platform without AI Agent
• AI Agent-Assisted Patient-Centered Support
• Delayed AI Agent-Assisted Patient-Centered Support
• Standard-of-Care Medical Treatment

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Male

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Supportive Care

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Fudan UniversityOTHER

bodai1978@126.com+86-21 64175590

yongy1974@163.com+86-0871 68185656

2818777033@qq.com+86 15000238255

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