Geriatric Assessment - Driven Interventions for Older Cancer Patients

描述(申请人提供)：超过60%的癌症发生在老年人，随着人口老龄化，老年癌症患者的数量预计会增加。老年癌症患者化疗并发症的风险增加，而且没有标准的方法来确定风险和实施干预措施来减少毒性。多项研究，包括癌症和老龄化研究小组(CARG)对500名患者的研究表明，46%的老年晚期癌症患者在开始治疗后3个月内因化疗而出现严重毒性，综合老年评估(GA)是一种评估老年人健康状况的有效方法，可以预测严重的化疗毒性。然而，对于如何将GA的信息转化为有可能预防或减少老年癌症患者的不良后果(例如，毒性、功能下降和生活质量降低)的有针对性的干预措施，还没有达成共识。 这项建议的首要目标是确定可以改善老年癌症患者预后的老年评估(GA)驱动的干预措施，创建一种实施这些干预措施的算法，并在随机先导研究中测试该算法。这项拟议研究的总体假设是，对老年患者实施遗传算法指导的干预措施的算法可以降低化疗毒性的风险，并保持或提高生活质量。首席研究员、一名老年肿瘤学家以及老年医生、肿瘤学家和老年肿瘤学家组成的研究团队通过CAG和U13会议系列资助“老年肿瘤学研究改善临床护理”聚集在一起，能够成功完成这项高影响的研究。在具体目标1中，我们将采用修改后的Delphi共识建立过程，与在第二届U13老年肿瘤学会议上召集的专家一起修订和最终确定针对癌症患者的GA驱动干预的算法。在具体目标2中，我们将进行一项随机试点研究(n=80)，以收集初步数据，以确定这种GA驱动的干预算法是否可以改善老年癌症患者的预后。正在开始新的化疗方案的70岁及以上晚期癌症患者将被随机分配到常规护理或拜访老年肿瘤团队，后者将在算法的指导下实施GA驱动的干预措施。主要结果将是比较化疗开始后3个月出现严重化疗毒性的患者的比例。次要结果将包括两组实施的干预措施数量的比较，以及生活质量、功能能力和体能表现的比较。由PI领导的CAPG研究团队将把这项建议的结果纳入罗切斯特大学社区临床肿瘤学计划(CCOP)内计划的R01，该计划将测试实施GA驱动的干预措施是否可以减少毒性并保持接受化疗的老年癌症患者的生活质量。 公共卫生相关性：超过60%的癌症发生在老年人中，预计老年癌症患者的数量将随着人口老龄化而增长。老年人化疗毒性的风险增加，老年评估变量可以识别那些有风险的老年人；然而，没有标准的算法用于老年评估驱动的干预措施，以防止老年癌症患者的不良后果。这项研究提案将使用一种创新的建立共识的方法来为老年评估(GA)驱动的干预创建一种算法，该算法可以改善患有癌症的老年人的结果，并将在随机试点研究中收集初步数据，以指导R01资助的最终临床试验的设计。

DESCRIPTION (provided by applicant): Over 60% of cancers occur in older persons, and the number of older cancer patients is expected to grow as the population ages. Older cancer patients are at increased risk of chemotherapy treatment complications, and there is no standard approach to identifying risk and implementing interventions to reduce toxicity. Several studies, including a Cancer and Aging Research Group (CARG) study in 500 patients, have demonstrated that 46% of older patients with advanced cancer have severe toxicity from chemotherapy within 3 months of treatment initiation and that comprehensive geriatric assessment (GA), a validated approach to assessing health status in older persons, can predict severe chemotherapy toxicities. No consensus exists, however, on how to translate information from the GA into targeted interventions that have potential to prevent or reduce adverse outcomes (e.g., toxicity, functional decline, and lower quality of life) for older cancer patients. The overarching goal of this proposal is to identify geriatric assessment (GA)-driven interventions that could improve outcomes of older adults with cancer, to create an algorithm to implement these interventions, and to test the algorithm in a randomized pilot study. The overall hypothesis of this proposed research is that an algorithm that implements interventions guided by GA for older patients can reduce the risk of chemotherapy toxicity and maintain or improve quality of life. The principal investigator, a geriatric oncologist, and the research team of geriatricians, oncologists, and geriatric oncologists assembled through CARG and a funded U13 conference series grant, "Geriatric Oncology Research to Improve Clinical Care" are well positioned to successfully complete this high-impact research. In specific aim 1, we will employ a modified Delphi consensus-building process with experts convened at the second U13 geriatric oncology conference to revise and finalize an algorithm for GA-driven interventions for cancer patients. In specific aim 2, we will conduct a randomized pilot study (n=80) to gather preliminary data on whether this algorithm for GA-driven interventions can improve outcomes of older cancer patients. Patients aged 70 and over with advanced cancer who are embarking on a new chemotherapy regimen will be randomized to usual care or a visit with a geriatric oncology team who will implement GA-driven interventions guided by the algorithm. The primary outcome will be a comparison of the proportion of patients who have severe chemotherapy toxicity at 3 months after chemotherapy initiation. Secondary outcomes will include a comparison of the number of interventions implemented in both groups and comparisons of quality of life, functional abilities, and physical performance. The CARG research team, led by the PI, will incorporate the results of this proposal in a planned R01 within the University of Rochester's Community Clinical Oncology Program (CCOP) that will test whether implementation of GA-driven interventions can reduce toxicity and maintain quality of life of older cancer patients receiving chemotherapy. PUBLIC HEALTH RELEVANCE: Over 60% of cancers occur in older persons, and the number of older cancer patients is expected to grow with the aging of the population. Older adults are at increased risk of chemotherapy toxicity and geriatric assessment variables can identify those older adults at risk; however, there is no standard algorithm for geriatric assessment driven interventions to prevent adverse outcomes in older cancer patients. This research proposal will use an innovative consensus-building approach to create an algorithm for geriatric assessment (GA)-driven interventions that could improve outcomes of older adults with cancer and will gather preliminary data in a randomized pilot study to guide the design of a definitive R01-funded clinical trial.