Optimizing prostate cancer care: integrating risks, benefits, and patient experiences in the new era of molecular imaging

优化前列腺癌护理：在分子成像新时代整合风险、收益和患者体验

• 批准号: 10712074
• 负责人: Michael Stuart Leapman
• 金额: $ 66.04万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-13 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10712074
• 关键词: Accounting; Affect; Aftercare; Age; Anxiety; Benefits and Risks; Biological; Cancer Etiology; Cessation of life; Characteristics; Clinical; Clinical Management; Clinical effectiveness; Complex; Data; Databases; Decision Making; Decision Modeling; Diagnostic; Diagnostic Neoplasm Staging; Dimensions; Disease; Disease Management; Disease Outcome; Disease Progression; Disseminated Malignant Neoplasm; Early Diagnosis; Effectiveness; Electronic Health Record; Evaluation; Funding; Goals; Harm Reduction; Health Care Costs; Hormones; Image; Individual; Institution; Interview; Knowledge; Lead; Life Expectancy; Long-Term Effects; Malignant neoplasm of prostate; Measures; Modeling; Motion; Outcome; Outcome Measure; Output; PSA level; Pathway interactions; Patient Outcomes Assessments; Patient Preferences; Patients; Performance; Physicians; Positron-Emission Tomography; Provider; Radiation; Refractory Disease; Risk; Risk Assessment; Role; Screening for Prostate Cancer; Source; Staging; Surrogate Endpoint; Systemic Therapy; Test Result; Testing; Time; Tracer; Treatment-related toxicity; Uncertainty; United States; United States Food and Drug Administration; Vacuum; Work; X-Ray Computed Tomography; androgen deprivation therapy; bone imaging; cancer care; cancer site; cancer type; castration resistant prostate cancer; clinical care; clinical efficacy; clinical risk; cost; cost effectiveness; data integration; diagnostic accuracy; effectiveness evaluation; experience; health related quality of life; holistic approach; imaging agent; imaging modality; improved; innovation; insight; men; models and simulation; molecular imaging; patient subsets; preference; psychologic; reduce symptoms; treatment duration

PROJECT SUMMARY/ABSTRACT A molecular imaging revolution is underway in prostate cancer. To overcome longstanding limitations in prostate cancer staging, several positron-emission tomography (PET) scans have recently been approved and rapidly integrated into clinical care based on evidence of improved diagnostic accuracy. However, the consequences of widespread PET imaging are unknown. This is because the approvals of these tests are based on improved diagnostic accuracy, a surrogate endpoint, rather than direct evidence of patient benefit. By finding small sites of cancer earlier, PET imaging could introduce a cascade of effects—both positive and negative—that could vary from patient to patient. PET imaging could lead to improved survival and fewer symptoms from metastatic cancer in a subset, but could also increase treatment toxicity, psychological burdens, and costs in others. Currently, no information is available to help guide patients or stakeholders when considering these tradeoffs. To reduce these uncertainties, our goal is to develop a decision model that considers the effects of PET imaging across multiple dimensions. To inform this model, we will generate real- world evidence from a diversity of sources. In aim one, we will conduct complementary analyses of large, nationally representative databases to evaluate the effectiveness of PET imaging, focusing on the associations between imaging initiation of systemic therapy, progression to hormone-refractory disease, and costs. In aim two, we will measure the longitudinal impact of PET imaging on patient-reported outcome measures relating to psychological effects (anxiety and uncertainty) and health-related quality of life. To gain a deeper perspective about patient experiences with testing we will also conduct longitudinal qualitative interviews among a smaller subset of patients and integrate the findings from quantitative and qualitative sources. In the third study aim we will incorporate inputs from Aims 1 and 2 to construct individual-based state-transition microsimulation models examining common scenarios for PET imaging use. The outputs from these models will include estimates of effectiveness, as well as patient characteristics that may be associated with greater or lesser degrees of benefit or harm. The results of this study will equip patients, providers, and other prostate cancer stakeholders with practical, new information about the potential short and long-term effects of PET imaging. If successful, this approach for evaluating effectiveness will be applicable to other similar molecular imaging modalities that will soon enter clinical care on the basis of surrogate endpoints of improved diagnostic accuracy, but without evidence of long-term clinical efficacy.

项目总结/文摘