Reducing Chemotherapy Toxicity in Older Adults

减少老年人的化疗毒性

• 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
• 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

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）：项目摘要：超过60％的癌症发生在老年人中，随着人口年龄的增长，老年癌症患者的数量预计将增加。老年癌症患者的治疗并发症风险增加，并且没有降低化学疗法毒性的标准方法。几项研究，包括500名患者的癌症和衰老研究小组（CARG）研究，表明50％的老年患者在治疗开始后的3个月内因化学疗法而患有严重的毒性，并且在老年评估（GA）内采取的措施是评估老年人健康状况的经过验证的方法，可以预测严重的化学疗法毒性。尽管老年评估具有改善癌症老年人不良后果的巨大潜力，但大多数肿瘤学家尚未采用GA，这主要是因为如何最好地将GA纳入临床护理中。这项拟议的研究的总体假设是，通过GA为老年患者指导的肿瘤学家提供老年评估的信息，可以降低化学疗法毒性的风险。首席研究员，一名老年肿瘤学家和通过CARG组装的研究团队在成功完成这项高影响力的研究方面有好处。该研究将分为两个阶段。在第1阶段，年龄在70岁及以上的患者（n = 240）患有实体肿瘤恶性肿瘤，他们计划在罗切斯特大学社区临床肿瘤学计划（CCOP）部位接受一线化学疗法。将捕获“通常的护理”实践，包括医师特征，处方模式，用于化学疗法开始的患者和医师决策以及化学疗法毒性。在第2阶段，我们将使用CCOP位点进行2臂群集随机研究。在开始化疗之前，具有转移性实体瘤恶性肿瘤的70岁及以上（n = 688）的患者将完成GA。随机分配到ARM 1的站点的肿瘤学家将收到GA结果的摘要以及针对实施的有针对性干预措施。在ARM 2中，肿瘤学家只会从GA中收到有关严重抑郁或认知障碍的信息。主要结果将是比较化学疗法开始后3个月患有严重化学疗法毒性的患者的比例。次要结果将包括生存的比较，两组中实施的干预措施的数量以及化学疗法的决策。探索目的将评估GA加上有针对性的干预措施是否会减慢晚期癌症患者的功能和身体下降。关于预期的结果，该提案将填补有关GA是否可以改善老年癌症患者预后以及GA如何改善生活质量的机制的重要差距（决策，GA驱动的干预措施）。这些数据将通过提供务实的机制来产生积极的影响，以将GA纳入常规临床肿瘤学护理中，以改善转移性癌症老年人的预后。