AI-Assisted Patient Support in mHSPC
ConditionMetastatic Prostate Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-80
SponsorFudan University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
The Same Platform without AI Agent
BehavioralThe 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
BehavioralParticipants 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
BehavioralParticipants 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
DrugParticipants 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Immediate AI Agent AccessExperimental treatment 2 interventions
Group B: Delayed AI Agent AccessActive comparator 3 interventions
Trial outcomes
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.
Time frame
At baseline and 2 weeks after randomization.Secondary outcomes
1
Between-Group Difference in Disease Knowledge Test Total Score at 2 Weeks
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.
Time frame
At 2 weeks after randomization.2
Between-Group Difference in Change from Baseline in the Brief Illness Perception Questionnaire (B-IPQ) Total Score at 2 Weeks
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.
Time frame
At baseline and 2 weeks after randomization.3
Between-Group Difference in Change from Baseline in the Insomnia Severity Index (ISI) Total Score at 2 Weeks
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.
Time frame
At baseline and 2 weeks after randomization.4
Between-Group Difference in Change from Baseline in the Patient Satisfaction Questionnaire-18 (PSQ-18) Score at 2 Weeks
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.
Time frame
At baseline and 2 weeks after randomization.Other outcomes
1
Between-Group Difference in Change from Baseline in GAD-7 Total Score at 4 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 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.
Time frame
At baseline and 4 weeks after randomization.2
Accuracy of LLM-Generated Answers to Participant Questions
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.
Time frame
During the 4-week study period.Sponsors and contacts
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Source ClinicalTrials.gov
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