ECOG-ACRIN NCORP Research Base

ECOG-ACRIN NCORP研究基地

• 批准号: 10288634
• 负责人: Peter J ODwyer
• 金额: $ 38.53万
• 依托单位: ECOG-ACRIN MEDICAL RESEARCH FOUNDATION
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-08-01 至 2025-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10288634
• 关键词: Adjuvant; Administrative Supplement; African American; Aftercare; Age; Aging; Alzheimer disease prevention; Alzheimer' s Disease; Alzheimer' s disease related dementia; Alzheimer' s disease risk; American College of Radiology Imaging Network; Amyloid beta-Protein; Androgens; Attention; Biological Process; Black race; Cancer Control Research; Cancer Patient; Cancer Survivor; Cancer Survivorship; Caring; Characteristics; Clinical Treatment; Cognitive; Community Clinical Oncology Program; Computer Models; Computer software; Data; Data Set; Decision Making; Dementia; Diagnosis; Disease; Eastern Cooperative Oncology Group; Elderly; Enrollment; Event; Executive Dysfunction; Exposure to; Face; Funding; Gleason Grade for Prostate Cancer; Goals; Grant; Growth; Health; Impaired cognition; Impairment; Individual; Infrastructure; Investments; Knowledge; Lead; Link; Longitudinal cohort; Malignant Neoplasms; Malignant neoplasm of prostate; Medicare; Medicare claim; Memory; Methodology; Mission; National Cancer Advisory Board; National Clinical Trials Network; Neurons; Outcome; Participant; Patient risk; Patients; Prostate; Prostate Cancer therapy; Public Health; Quality of life; Recommendation; Records; Regimen; Reproducibility; Research; Resources; Risk; Risk Estimate; Social Security Number; Symptoms; Techniques; Testing; Testosterone; Therapeutic; Therapeutic Trials; Therapy trial; Time; Treatment-Related Cancer; Treatment-related toxicity; United States National Institutes of Health; Work; adverse outcome; androgen deprivation therapy; base; black patient; cancer care; cancer risk; cancer therapy; chemotherapy; cognitive function; cost; cost efficient; dementia risk; disability; docetaxel; executive function; follow-up; health care service utilization; health related quality of life; human disease; improved; information processing; link protein; member; negative affect; neurotoxic; older patient; open source; primary endpoint; programs; prostate cancer survivors; randomized trial; survivorship

PROJECT SUMMARY As an NCORP Research Base, ECOG-ACRIN's (EA) goal is to improve quality of life and cancer survivorship through cancer control research that examines and intervenes on challenges associated with cancer treat- ment-related symptoms and concerns. Many systemic cancer therapies, including chemotherapy- and non- chemotherapy-based regimens such as androgen deprivation therapy (ADT) for prostate cancer, have neuro- toxic effects which could lead to impaired cognitive function and ultimately Alzheimer's disease and related de- mentias (ADRD). However, cancer therapy trials (including EA trials) are limited in their ability to assess late cognitive effects because follow-up is restrained to the time horizon needed for the primary endpoint due to cost constraints. As a result, we cannot determine a patient's risk of late ADRD, and incorporate these risks into the therapeutic decision-making. A long-term goal of the EA NCORP is to improve the care of cancer sur- vivors through identification of cancer-treatment related toxicities. The overall objective of this Administrative Supplement is to develop a sustained EA resource for the cost-efficient ascertainment of long-term ADRD out- comes in cancer survivors by linking EA trials with Medicare claims data in the absence of unique identifiers. Our central hypothesis is that probabilistic linkage methodologies will be highly accurate in linking EA trial par- ticipants to their Medicare data thereby allowing us to ascertain AD/ADRD diagnoses. To test this hypothesis, we will probabilistically link a large prostate cancer trial of chemohormonal therapy (i.e. docetaxel + ADT) to Medicare claims, identify patients who were diagnosed with AD/ADRD and estimate the risk of developing AD/ADRD up to 10 years after treatment. The rationale for the proposed work is that, by knowing the risks of AD/ADRD among cancer patients, we will characterize treatment toxicities and improve the care of these indi- viduals. We have two Specific Aims: Aim 1. Describe the demographic, clinical, and treatment characteristics of prostate cancer patients who developed ADRD after ADT-based therapy and determine how these charac- teristics influence the risk of ADRD. Aim 2. Establish a methodology that enables the efficient and accurate linkage of EA trials with Medicare data to identify trial participants diagnosed with ADRD after trial completion.. Under Aim 1, we will determine if patients treated with docetaxel + ADT have higher AD/ADRD risk compared to patients treated with ADT alone and whether this risk is increased among older patients, those with high- volume disease, higher Gleason score, patients of Black race, and patients who received adjuvant ADT. Under Aim 2, we will develop computational models and open-source reproducible software for the probabilistic link- age of EA trials with Medicare. Our results are expected to have a positive impact because they will optimize the cost-efficient long-term and post-trial survivorship follow-up of patients enrolled in federally-funded cooper- ative trials for the identification of ADRD-related adverse outcomes due to cancer treatments.

项目摘要 作为NCORP研究基础，Ecog-Acrin（EA）的目标是改善生活质量和癌症生存 通过癌症控制研究，研究并介绍了与癌症治疗相关的挑战 与MENT相关的症状和关注点。许多全身性癌症疗法，包括化学疗法和非 - 基于化学疗法的方案，例如前列腺癌的雄激素剥夺治疗（ADT），具有神经性 有毒作用可能导致认知功能受损，并最终导致阿尔茨海默氏病及其相关的疾病 Mentias（Adrd）。但是，癌症治疗试验（包括EA试验）的评估能力有限 认知效应是因为随访被限制为由于 成本限制。结果，我们无法确定患者迟到的风险，并纳入这些风险 进入治疗决策。 EA NCORP的长期目标是改善对癌症的护理 通过鉴定癌症治疗相关的毒性来体内。此行政的总体目标 补充是为了确定长期adrd of-of-of-of- 在没有唯一标识符的情况下，将EA试验与Medicare索赔数据联系起来，将EA试验与Medicare索赔数据联系起来。 我们的核心假设是，概率链接方法将在将EA试验的联系中高度准确 Ticipant掌握了其Medicare数据，从而使我们可以确定广告/ADRD诊断。为了检验这一假设， 我们将概率地将化学瘤疗法（即多西他赛 + ADT）的大型前列腺癌试验与 Medicare索赔，确定被诊断出患有AD/ADRD的患者，并估计有发展的风险 AD/ADRD治疗后10年。拟议工作的理由是，通过知道 癌症患者中的AD/ADRD，我们将表征治疗毒性并改善对这些内部的护理 viduals。我们有两个具体的目标：目标1。描述人口统计学，临床和治疗特征 在基于ADT的治疗后开发ADRD的前列腺癌患者，并确定这些特征 特性影响ADRD的风险。目标2。建立一种能够有效而准确的方法 EA试验与Medicare数据的联系，以确定试验完成后诊断为ADRD的试验参与者。 在AIM 1下，我们将确定接受多西他赛 + ADT治疗的患者是否具有更高的AD/ADRD风险 对于单独接受ADT治疗的患者以及老年患者中这种风险是否增加，患有高的患者 体积疾病，更高的Gleason评分，黑人种族患者以及接受ADT辅助的患者。在下面 AIM 2，我们将为概率链接开发计算模型和开源可再现软件 - Medicare试验的EA年龄。我们的结果预计将产生积极的影响，因为它们将优化 成本效益的长期和后审判后的幸存随访，该随访的患者参加了联邦资助的Cooper- 由于癌症治疗而导致的ADRD相关不良结果的ATIVE试验。