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临床试验/NCT06856694
NCT06856694招募中不适用

Natural Language Processing-Based Feedback to Improve Physician Risk Communication and Informed Shared Decision Making in Men With Clinically Localized Prostate Cancer

Cedars-Sinai Medical Center2 个研究点 分布在 1 个国家目标入组 283 人开始时间: 2025年10月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
283
试验地点
2
主要终点
Decisional conflict

研究概览

简要总结

The purpose of the research is to assess the impact of a natural language processing + artificial intelligence (NLP+AI)-based risk communication feedback system to improve quality of risk communication of key tradeoffs during prostate cancer consultations among physicians and to improve patient decision making. In this cluster randomized trial, an evaluable 259 patients with newly diagnosed clinically localized prostate cancer will be cluster randomized within an evaluable 24 physicians to:

  1. a control arm, in which patients will receive standard of care treatment consultations along with AUA-endorsed educational materials on treatment risks and benefits (for patients) and on SDM (for physicians) or
  2. an experimental arm, in which patients and participating physicians will receive NLP+AI-based feedback on what was said about key tradeoffs within approximately 72 hours of the consultation to assist with decision making. Physicians will additionally be provided with grading of their risk communication for each visit based on an a priori defined framework for quality of risk communication and recommendations for improvement.

In both study arms, there will be an audio-recorded follow-up phone or video call between the physician and patient to allow for further discussion of risk and clarifying any areas of ambiguity, which will be qualitatively analyzed to see if areas of poor communication were rectified. After the follow-up phone call, patients and participating physicians will be asked to complete a very brief survey about their experience.

The study plans to test whether receiving NLP+AI-based feedback improves decisional conflict, shared decision making, and appropriateness of treatment choice over the standard of care in patients undergoing treatment consultations for prostate cancer. Study staff will also test whether providing feedback and grading of risk communication to physicians affects quality of physician risk communication, since providing feedback will promote more accountability for the quality of information provided to patients. The study will also analyze data from the control arm of the randomized controlled trial to understand variation in risk communication of key tradeoffs in relevant subgroups of tumor risk (low-, intermediate-, and high-risk), provider specialty (Urology, Radiation Oncology, Medical Oncology), and patient sociodemographics.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Physician Inclusion Criteria
  • •(1) Physicians who typically counsel prostate cancer patients (Urology, Radiation Oncology, Medical Oncology)
  • •Patient Inclusion Criteria
  • •Patients undergoing initial treatment consultation for clinically localized prostate cancer;
  • •Patients with upgraded prostate cancer on active surveillance considering conversion to definitive local therapy;
  • •Ability to read and write in English.

排除标准

  • •Under 18 years of age;
  • •Subjects with difficulty communicating or dementia;
  • •Non-English speakers, given that our NLP-based tools cannot be used with languages other than English;
  • •Patients with locally advanced or metastatic prostate cancer;
  • •Patients who have already been treated for clinically localized prostate cancer.

研究组 & 干预措施

NLP-Based Feedback Arm

Experimental

干预措施: NLP+AI Report (Other)

Standard of Care Arm

No Intervention

patients will receive standard of care treatment consultations along with AUA-endorsed educational materials on treatment risks and benefits (for patients) and on SDM (for physicians)

结局指标

主要结局

Decisional conflict

时间窗: 2-4 weeks (from diagnosis and enrollment through the completion of post feedback survey)

Decisional conflict is a patient-level outcome between intervention and control and will be measured using the validated Decisional Conflict Scale (DCS) questionnaire, where participants will list if they strongly agree, agree, neither, disagree, or strongly disagree with the provided statements

Shared decision-making

时间窗: 2-4 weeks (from diagnosis and enrollment through the completion of post feedback survey

Shared decision making will be patient-reported and measured using the validated SDMP-4 questionnaire.

Appropriateness of treatment choice

时间窗: 2-4 weeks (from diagnosis and enrollment through the completion of post feedback survey)

Appropriateness of treatment choice will be determined a priori based on previously published measures determined by treatment guidelines.

Quality of risk communication

时间窗: 6-9 months (post study analysis)

Physician level outcome-that will measure the difference in composite quality of physician risk communication between the experimental and control arms. Quality of physician risk communication will be measured using a previously published hierarchical scale that is specific to communication of cancer prognosis, life expectancy, and treatment-related side effects.

次要结局

  • Improvement of risk communication(6-9 months (post study analysis))
  • Risk Perception and Patient Satisfaction(6-9 months (post study analysis))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Timothy J. Daskivich

Staff Physician II

Cedars-Sinai Medical Center

研究点 (2)

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