Reducing Chemotherapy Toxicity in Older Adults

减少老年人的化疗毒性

基本信息

批准号：
9319634
负责人：
Supriya G. Mohile
金额：
$ 49.54万
依托单位：
UNIVERSITY OF ROCHESTER
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-09-09 至 2019-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9319634
关键词：
Address Admission activity Advanced Malignant Neoplasm Age Aging Area Assessment tool Cancer Center Cancer Patient Caring Characteristics Chemotherapy-Oncologic Procedure Clinical Oncology Collaborations Common Terminology Criteria for Adverse Events Community Clinical Oncology Program Data Decision Making Disseminated Malignant Neoplasm Dose Elderly Enrollment Geriatric Assessment Goals Health Health Status Hospitalization Impaired cognition Intervention Joints Knowledge Malignant Neoplasms Measures Medical Mental Depression Morbidity - disease rate Nursing Homes Oncologist Outcome Patients Pattern Performance Status Phase Physicians Population Positioning Attribute Prevention Principal Investigator Quality of Care Quality of life Randomized Recruitment Activity Research Research Priority Risk Role Site Solid Neoplasm Toxic effect Toxicity due to chemotherapy Translational Research Universities adverse outcome aged anticancer research arm base cancer therapy chemotherapy clinical care disability falls improved improved outcome mortality older patient oncology oncology program prevent primary outcome public health relevance secondary outcome symposium tool treatment as usual

项目摘要

DESCRIPTION (provided by applicant): Project Summary: 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 treatment complications, and there is no standard approach for reducing chemotherapy toxicity. Several studies, including a Cancer and Aging Research Group (CARG) study in 500 patients, have demonstrated that 50% of older patients have severe toxicity from chemotherapy within 3 months of treatment initiation and that measures within a geriatric assessment (GA), a validated approach to assessing health status in older persons, can predict severe chemotherapy toxicities. Although geriatric assessment has great potential to improve adverse outcomes of older adults with cancer, the majority of oncologists have not adopted GA, largely because of lack of knowledge on how to best incorporate GA into clinical care. The overall hypothesis of this proposed research is that providing oncologists with information from geriatric assessment with and targeted interventions guided by GA for older patients can reduce the risk of chemotherapy toxicity. The principal investigator, a geriatric oncologist, and the research team assembled through CARG are well positioned to successfully complete this high-impact research. The study will be conducted in 2 phases. In Phase 1, patients aged 70 and over (n=240) with metastatic solid tumor malignancies who are planning to receive first-line chemotherapy at University of Rochester Community Clinical Oncology Program (CCOP) sites will be recruited over the course of 1 year. "Usual-care" practices including physician characteristics, prescribing patterns, patient and physician decision-making for chemotherapy initiation, and chemotherapy toxicity will be captured. In Phase 2, we will conduct a 2-armed cluster randomized study utilizing CCOP sites. Prior to chemotherapy initiation, patients aged 70 and over (n=688) with metastatic solid tumor malignancies will complete a GA. The oncologists at sites randomized to Arm 1 will receive a summary of GA results plus targeted interventions to consider for implementation. In Arm 2, oncologists will only receive information from GA regarding severe depression or cognitive impairment. 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 comparisons of survival, the number of interventions implemented in both groups, and decision-making for chemotherapy. An exploratory aim will evaluate whether or not GA plus targeted interventions can slow functional and physical decline in older patients with advanced cancer. With regard to expected outcomes, this proposal will fill vital gaps in knowledge regarding whether GA can improve outcomes of older cancer patients and the mechanisms of how GA can improve quality of life (decisions, GA-driven interventions). These data will have a positive impact by providing a pragmatic mechanism for incorporating GA into routine clinical oncology care to improve outcomes of older adults with metastatic cancer.

描述（由申请人提供）：项目概要：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加。老年癌症患者出现治疗并发症的风险增加，并且没有减少化疗毒性的标准方法。多项研究，包括一项针对 500 名患者进行的癌症与衰老研究小组 (CARG) 研究，表明 50% 的老年患者在治疗开始后 3 个月内出现严重的化疗毒性，并且在老年评估 (GA) 内进行测量，该评估是经过验证的老年患者评估 (GA) 的结果。评估老年人健康状况的方法可以预测严重的化疗毒性。尽管老年评估在改善患有癌症的老年人的不良结局方面具有巨大潜力，但大多数肿瘤学家尚未采用 GA，很大程度上是因为缺乏如何最好地将 GA 纳入临床护理的知识。这项拟议研究的总体假设是，为肿瘤学家提供老年评估信息以及 GA 指导的针对老年患者的有针对性的干预措施可以降低化疗毒性的风险。首席研究员、一位老年肿瘤学家和 CARG 组建的研究团队完全有能力成功完成这项高影响力的研究。该研究将分两个阶段进行。在第一阶段，将在一年的时间内招募计划在罗彻斯特大学社区临床肿瘤计划（CCOP）站点接受一线化疗的70岁及以上（n = 240）患有转移性实体瘤恶性肿瘤的患者。将捕获“常规护理”实践，包括医生特征、处方模式、患者和医生对化疗开始的决策以及化疗毒性。在第二阶段，我们将利用 CCOP 站点进行 2 臂整群随机研究。在开始化疗之前，70 岁及以上患有转移性实体瘤恶性肿瘤的患者 (n=688) 将完成 GA。随机分配到第 1 组的地点的肿瘤学家将收到 GA 结果摘要以及需要考虑实施的有针对性的干预措施。在第 2 组中，肿瘤科医生只会从 GA 收到有关严重抑郁或认知障碍的信息。主要结果是比较化疗开始后 3 个月出现严重化疗毒性的患者比例。次要结果将包括生存率比较、两组实施的干预措施数量以及化疗决策。一项探索性目标将评估 GA 加上有针对性的干预措施是否可以减缓患有晚期癌症的老年患者的功能和身体衰退。关于预期结果，该提案将填补关于 GA 是否可以改善老年癌症患者的结果以及 GA 如何改善生活质量的机制（决策、GA 驱动的干预措施）方面的重要知识空白。这些数据将产生积极影响，提供一种实用机制，将 GA 纳入常规临床肿瘤护理，以改善患有转移性癌症的老年人的治疗结果。