Advancing Capacity to Integrate Exercise into the Care of Older Cancer Survivors: The ACES initiative to establish guidelines, feasibility and best practices for research in cancer and aging

提高将运动纳入老年癌症幸存者护理的能力：ACES 倡议为癌症和衰老研究制定指南、可行性和最佳实践

• 批准号: 10739672
• 负责人: KERRI M WINTERS-STONE
• 金额: $ 14.33万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10739672
• 关键词: Accidents; Activities of Daily Living; Adverse event; Aerobic; Aerobic Exercise; Age; Aging; American; American Society of Clinical Oncology; Cancer Science; Cancer Survivor; Caring; Cessation of life; Chemotherapy-induced peripheral neuropathy; Clinical; Clinical Oncology; Clinical Trials; Cognitive; Communities; Complex; Consensus; Data Reporting; Delphi Study; Dependence; Development; Disease; Dose; Elderly; Exclusion; Exercise; Family; Fatigue; Functional disorder; Funding; Future; Geriatrics; Guidelines; Health; Healthcare Systems; Impaired cognition; Infrastructure; Injury; Intervention; Knowledge; Life Style; Malignant Neoplasms; Medical Oncology; Modification; Oncology; Outcome; Pain; Patient Education; Patients; Pharmaceutical Preparations; Phase; Physical Function; Population; Positioning Attribute; Practice Guidelines; Protocols documentation; Publishing; Quality of life; Recommendation; Research; Research Infrastructure; Resistance; Resources; Risk; Safety; Societies; Sports Medicine; Survivors; Treatment Efficacy; United States National Institutes of Health; Update; cancer therapy; clinical practice; college; comorbidity; comparison group; cost; depressive symptoms; design; disability; efficacy trial; experience; fall injury; falls; feasibility trial; functional decline; functional improvement; functional outcomes; human old age (65+); improved; improved outcome; infrastructure development; innovation; interdisciplinary collaboration; mode of exercise; novel; older patient; oncology trial; phase 1 designs; phase 1 study; phase I trial; preservation; research in practice; resistance exercise; safety and feasibility; scale up; social; survivorship; systematic review; virtual; working group

The growing number of aging cancer survivors will pose a significant challenge for the healthcare system because of the combined effects of cancer treatment and aging on the development of comorbid disease, disability, and accidental death from injuries such as falls. Withinjust 5 years the number of older survivors in theUnited States alone is projected to reach 14 million.Exercise has the potential to improve functioning and QoL in older adults with cancer, however, and despite recent American to survivors. Research because exercise guidelines for cancer survivors from an College of Sports Medicine (ACSM) and the American Society of Clinical Oncology (ASCO) but, due the lack of clinical trials in older cancer survivors, neither position issued age-specific guidelines for older Thus, clinical practice remains bereft of guidance to include exercise in care plans for older patients. in older adults with complex health needs is challenging and they are often excluded from clinical trials teams lack the expertise, experience and resources.An NIH funded cancer, exercise and aging expert group they noted an absence of rigorously planned phase I-II feasibility trials for different exercise modalities that would subsequently inform the a priori design of phase III efficacy trials. Despite this urgent call, there have been no rigorously designed phase I studies in older cancer survivors, including those with functional limitations, to establish the feasibility and safety of any exercise modality and particularly, resistance training. The exercise research improve lack of guidelines and the paucity of clinical t rials specific t o older cancer survivors creates a significant gap that i s impeding the implementation of exercise as a low-cost, accessible, and scalable strategy to outcomes for older survivors.We are directly responding to NOT-CA-22-030 stating NCI's participation in PA-20-070 Research Infrastructure Development for Interdisciplinary Aging Studies that calls for phased R21/R33 applications for “studies that propose advance developing or scaling up a novel research infrastructure that will the science of cancer and aging requiring interdisciplinary collaborations”. Per the PA-20-070 guidelines requiring milestone-driven projects, we propose the following phased R21 to R33 projects: R21 project: Develop consensus-based guidelines for exercise in older (65+) cancer survivors by: 1) assembling a community advisory board for stakeholder input (Y1); 2) conducting a review of published trials and trials in progress (Y1), 3) conducting a Delphi study to outline an initial set of exercise recommendations (Y1); 4) convening an interdisciplinary working group of experts to develop consensus-based exercise guidelines for older cancer survivors (Y2); and, 5) finalizing a guideline-concordant R33 project protocol (Y2). R33 project: Establish the feasibility and safety of resistance training in older functionally limited cancer survivors by: 1) conducting a phase I trial that is concordant with guidelines from the R21 (Y3-5), 2) establishing appropriate comparison groups for futures studies of functional outcomes in older cancer survivors (Y5) and 3) producing a set of best practice guidelines for the conduct of clinical exercise trials in older adults (Y5).

越来越多的老年癌症幸存者将对医疗保健系统构成重大挑战 由于癌症治疗和衰老对共病发展的联合作用， 残疾和意外死亡的伤害，如福尔斯。在短短5年内， 仅美国就预计达到1400万。锻炼有可能改善身体机能， 然而，老年癌症患者的生活质量，尽管最近 美国 到 幸存者 研究 因为 癌症幸存者的锻炼指南， 运动医学学院（ACSM）和美国临床肿瘤学会（ASCO），但由于 由于缺乏对老年癌症幸存者的临床试验，两个职位都没有为老年人发布针对年龄的指导方针， 因此，临床实践仍然缺乏指导，将运动纳入老年患者的护理计划。 在有复杂健康需求的老年人中，这是一个挑战，他们经常被排除在临床试验之外。 团队缺乏专业知识、经验和资源。一位由美国国立卫生研究院资助的癌症、运动和衰老专家 他们指出，没有对不同的演习模式进行严格规划的第一阶段和第二阶段可行性试验 这将随后告知III期疗效试验的先验设计。尽管有这一紧急呼吁， 在老年癌症幸存者中没有严格设计的I期研究，包括那些功能受限的患者， 建立任何运动方式的可行性和安全性，特别是阻力训练。的 行使 研究 提高 缺乏 指南和缺乏针对老年癌症幸存者的临床试验， 差距阻碍了将锻炼作为一种低成本、可访问和可扩展的策略来实施， 我们直接回应NOT-CA-22-030，说明NCI的参与 在PA-20-070跨学科老龄化研究的研究基础设施开发中， R21/R33的应用“研究建议 提前 开发或扩大新的研究基础设施， 需要跨学科合作的癌症和衰老科学”。根据PA-20-070指南 由于需要里程碑式的项目，我们建议分阶段进行以下R21至R33项目：R21项目： 通过以下方式为老年（65岁以上）癌症幸存者制定基于共识的运动指南：1）组建社区 利益相关者意见咨询委员会（Y1）; 2）对已发表的试验和正在进行的试验进行审查（Y1）， 3)进行一项德尔菲研究，以概述一套初步的演习建议（Y1）; 4）召开一次 跨学科专家工作组为老年癌症制定基于共识的运动指南 幸存者（Y2）;以及，5）最终确定与指南一致的R33项目方案（Y2）。R33项目：建立 老年功能受限癌症幸存者阻力训练的可行性和安全性：1）进行阶段 I试验与R21（Y3-5）指南一致，2）建立适当的比较组， 老年癌症幸存者（Y 5）功能结局的未来研究; 3）制定一套最佳实践 老年人临床运动试验指南（Y 5）。