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Key takeaways for knowledge expansion of early-career scientists conducting Transdisciplinary Research in Energetics and Cancer (TREC): a report from the TREC Training Workshop 2022. 开展 "能量与癌症跨学科研究"(TREC)的早期职业科学家的知识拓展要点:"能量与癌症跨学科研究 "2022 年培训研讨会报告。
Pub Date : 2023-05-04 DOI: 10.1093/jncimonographs/lgad005
Che-Pei Kung, Meghan B Skiba, Erika J Crosby, Jessica Gorzelitz, Mary A Kennedy, Bethany A Kerr, Yun Rose Li, Sarah Nash, Melanie Potiaumpai, Amber S Kleckner, Dara L James, Michael F Coleman, Ciaran M Fairman, Gloria C Galván, David O Garcia, Max J Gordon, Mathilde His, Lyndsey M Hornbuckle, So-Youn Kim, Tae-Hyung Kim, Amanika Kumar, Mélanie Mahé, Karen K McDonnell, Jade Moore, Sangphil Oh, Xinghui Sun, Melinda L Irwin

The overall goal of the annual Transdisciplinary Research in Energetics and Cancer (TREC) Training Workshop is to provide transdisciplinary training for scientists in energetics and cancer and clinical care. The 2022 Workshop included 27 early-to-mid career investigators (trainees) pursuing diverse TREC research areas in basic, clinical, and population sciences. The 2022 trainees participated in a gallery walk, an interactive qualitative program evaluation method, to summarize key takeaways related to program objectives. Writing groups were formed and collaborated on this summary of the 5 key takeaways from the TREC Workshop. The 2022 TREC Workshop provided a targeted and unique networking opportunity that facilitated meaningful collaborative work addressing research and clinical needs in energetics and cancer. This report summarizes the 2022 TREC Workshop's key takeaways and future directions for innovative transdisciplinary energetics and cancer research.

年度跨学科能量学与癌症研究(TREC)培训讲习班的总体目标是为能量学与癌症和临床护理领域的科学家提供跨学科培训。2022 年讲习班包括 27 名职业生涯早期到中期的研究人员(学员),他们从事基础、临床和人口科学等不同 TREC 研究领域的工作。2022 研修班学员参加了 "画廊漫步 "活动,这是一种互动式定性项目评估方法,旨在总结与项目目标相关的主要收获。学员们组成了写作小组,共同总结了 TREC 研习班的 5 项主要收获。2022 TREC 研讨会提供了一个有针对性的独特交流机会,促进了有意义的合作工作,满足了能量学和癌症方面的研究和临床需求。本报告总结了2022 TREC研讨会的主要收获以及跨学科能量学和癌症创新研究的未来方向。
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引用次数: 0
Linking social and built environmental factors to leisure-time physical activity in rural cancer survivors. 将社会和建筑环境因素与农村癌症幸存者的闲暇体育活动联系起来。
Pub Date : 2023-05-04 DOI: 10.1093/jncimonographs/lgad004
Courtney J Stevens, Yue Liao, Minxing Chen, Natalia I Heredia, Hannah Arem, Jasmine Sukumar, Lenat Joffe, Kathryn H Schmitz, Scherezade K Mama

Background: This study explored associations between social and built environmental factors and leisure-time physical activity (LTPA) in rural cancer survivors (RCS) and whether these associations differed by exercise stage of change (SOC).

Method: RCS (n = 219) completed questionnaires assessing LTPA, SOC, and social (social status, connectedness, support) and environmental (home environment, neighborhood environment) factors. Linear regression models examined associations between social and built environmental factors and LTPA and tested for moderation by SOC.

Results: Half (50.7%) of RCS were physically active, and 49.3% were not active. Social factors positively associated with LTPA included subjective social status in the community (B = 89.0, P = .014) and in the United States (B = 181.3, P < .001), social connectedness (B = 122.3, P = .024), and social support for physical activity from family (B = 41.9, P < .001) and friends (B = 44.3, P < .001). Environmental factors positively associated with LTPA included the home environment (B = 111.2, P < .001), perceived environmental support for PA (B = 355.4, P = .004), and neighborhood attributes, including bicycling infrastructure (B = 191.3, P = .003), proximity to recreation facilities (B = 140.1, P = .021), traffic safety (B = 184.5, P = .025), and aesthetics (B = 342.6, P < .001). SOC statistically significantly moderated the association between social status in the United States and LTPA (B = 160.3, P = .031).

Conclusions: Social and built environmental factors were consistently linked with LTPA and provide context for multilevel interventions promoting LTPA in RCS.

背景:本研究探讨了农村癌症幸存者(RCS)的社会和建筑环境因素与闲暇时间体力活动(LTPA)之间的关系,以及这些关系是否因运动变化阶段(SOC)而有所不同:本研究探讨了农村癌症幸存者(RCS)的社会和建筑环境因素与闲暇时间体育活动(LTPA)之间的关系,以及这些关系是否因运动变化阶段(SOC)而有所不同:方法:农村癌症幸存者(n = 219)填写调查问卷,评估闲暇时间体育锻炼(LTPA)、SOC、社会因素(社会地位、联系、支持)和环境因素(家庭环境、邻里环境)。线性回归模型检验了社会因素和建筑环境因素与LTPA之间的关联,并检验了SOC的调节作用:结果:半数(50.7%)的社区居民参加体育锻炼,49.3%的居民不参加体育锻炼。与长期体育锻炼积极相关的社会因素包括在社区(B = 89.0,P = .014)和美国(B = 181.3,P 结论:社会和建筑环境因素与长期体育锻炼积极相关:社会和建筑环境因素与长跑运动持续相关,并为多层次的干预措施提供了背景,促进了 RCS 中的长跑运动。
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引用次数: 0
Correction to: Enhancing Health Equity Through Cancer Health Economics Research. 修正为:通过癌症健康经济学研究增强健康公平。
Pub Date : 2022-12-15 DOI: 10.1093/jncimonographs/lgac018
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引用次数: 0
Integrating Geriatric Assessment Measures into National Cancer Institute Clinical Trials. 将老年评估措施纳入国家癌症研究所临床试验。
Pub Date : 2022-12-15 DOI: 10.1093/jncimonographs/lgac021
Allison Magnuson, Noam Van der Walde, June M McKoy, Tanya M Wildes, Melisa L Wong, Jennifer Le-Rademacher, Richard F Little, Heidi D Klepin
To improve the care of older adults with cancer, the traditional approach to clinical trial design needs to be reconsidered. Older adults are underrepresented in clinical trials with limited or no information on geriatric-specific factors, such as cognition or comorbidities. To address this knowledge gap and increase relevance of therapeutic clinical trial results to the real-life population, integration of aspects relevant to older adults is needed in oncology clinical trials. Geriatric assessment (GA) is a multidimensional tool comprising validated measures assessing specific health domains that are more frequently affected in older adults, including aspects related to physical function, comorbidity, medication use (polypharmacy), cognitive and psychological status, social support, and nutritional status. There are several mechanisms for incorporating either the full GA or specific GA measures into oncology therapeutic clinical trials to contribute to the overarching goal of the trial. Mechanisms include utilizing GA measures to better characterize the trial population, define trial eligibility, allocate treatment receipt within the context of the trial, develop predictive models for treatment outcomes, guide supportive care strategies, personalize care delivery, and assess longitudinal changes in GA domains. The objective of this manuscript is to review how GA measures can contribute to the overall goal of a clinical trial, to provide a framework to guide the selection and integration of GA measures into clinical trial design, and ultimately enable accrual of older adults to clinical trials by facilitating the design of trials tailored to older adults treated in clinical practice.
为了改善老年癌症患者的护理,需要重新考虑传统的临床试验设计方法。老年人在临床试验中的代表性不足,关于老年特异性因素(如认知或合并症)的信息有限或没有。为了解决这一知识差距并增加治疗性临床试验结果与现实生活人群的相关性,肿瘤临床试验需要整合与老年人相关的方面。老年评估(GA)是一种多维工具,包括评估老年人更经常受到影响的特定健康领域的有效措施,包括与身体功能、合并症、药物使用(多种药物)、认知和心理状况、社会支持和营养状况有关的方面。有几种机制可以将全部GA或特定GA措施纳入肿瘤治疗性临床试验,以促进试验的总体目标。机制包括利用遗传测量来更好地描述试验人群,确定试验资格,在试验背景下分配治疗接收,开发治疗结果预测模型,指导支持性护理策略,个性化护理提供,以及评估遗传域的纵向变化。本文的目的是回顾遗传指标如何有助于临床试验的总体目标,提供一个框架来指导遗传指标的选择和整合到临床试验设计中,并最终通过促进为临床实践中治疗的老年人量身定制的试验设计,使老年人参与临床试验。
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引用次数: 5
Preface: Engaging Older Adults in Cancer Clinical Trials Conducted in the National Cancer Institute Clinical Trials Network: Opportunities to Enhance Accrual. 前言:让老年人参与国家癌症研究所临床试验网络进行的癌症临床试验:提高应计收益的机会。
Pub Date : 2022-12-15 DOI: 10.1093/jncimonographs/lgac020
Diane St Germain, Supriya G Mohile
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引用次数: 3
Infrastructure to Support Accrual of Older Adults to National Cancer Institute Clinical Trials. 支持老年人参与国家癌症研究所临床试验的基础设施。
Pub Date : 2022-12-15 DOI: 10.1093/jncimonographs/lgac025
Gretchen Kimmick, Mina S Sedrak, Grant Williams, Nadine J McCleary, Ashley E Rosko, Jeffrey L Berenberg, Rachel A Freedman, Mary Lou Smith, Amina Ahmed, Hyman B Muss, Selina Chow, William Dale

As part of ongoing efforts to meaningfully improve recruitment, enrollment, and accrual of older adults into cancer clinical trials, the National Cancer Institute (NCI) sponsored a workshop with experts across the country entitled Engaging Older Adults in the NCI Clinical Trials Network: Challenges and Opportunities. Three working groups, including Study Design, Infrastructure, and Stakeholders, were formed, who worked together to offer synergistic improvements in the system. Here, we summarize the workshop discussions of the Infrastructure Working Group, whose goal was to address infrastructural challenges, identify underlying resources, and offer solutions to facilitate accrual of older adults into cancer clinical trials. Based on preconference work and workshop discussions, four key recommendations to strengthen NCI infrastructure were proposed: 1) further centralize resources and expertise; 2) provide training for clinical research staff; (3) develop common data elements; and 4) evaluate what works and does not work. These recommendations provide a strategy to improve the infrastructure to enroll more older adults in cancer clinical trials.

美国国家癌症研究所(NCI)一直在努力有意义地改善癌症临床试验中老年人的招募、注册和应计工作,作为这项努力的一部分,该研究所与全国各地的专家共同主办了一次题为 "让老年人参与 NCI 临床试验网络 "的研讨会:挑战与机遇 "的研讨会。会议成立了三个工作小组,包括研究设计、基础设施和利益相关者,他们共同协作,对系统进行了协同改进。在此,我们总结了基础设施工作组的研讨会讨论情况,该工作组的目标是应对基础设施方面的挑战、确定基础资源并提供解决方案,以促进老年人参与癌症临床试验。在会前工作和研讨会讨论的基础上,提出了加强国家癌症研究所基础设施的四项主要建议:1) 进一步集中资源和专业知识;2) 为临床研究人员提供培训;3) 开发通用数据元素;以及 4) 评估哪些有效,哪些无效。这些建议为改善基础设施,让更多老年人参与癌症临床试验提供了策略。
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引用次数: 0
Trial Design Considerations to Increase Older Adult Accrual to National Cancer Institute Clinical Trials. 增加国家癌症研究所临床试验老年人应计数的试验设计考虑。
Pub Date : 2022-12-15 DOI: 10.1093/jncimonographs/lgac023
Jennifer Le-Rademacher, Supriya Mohile, Joseph Unger, Matthew F Hudson, Jared Foster, Stuart Lichtman, Jane Perlmutter, Efrat Dotan, Martine Extermann, Kevin Dodd, William Tew, Heidi Klepin, Tanya M Wildes, Mina S Sedrak, Aminah Jatoi, Richard F Little

Although adults aged 65 years or older make up a strong majority of cancer patients, their underrepresentation in cancer clinical trials leads to the lack of representative data to guide evidence-based therapeutic decisions in this patient population. The Trial Design Working Group, convened as part of the workshop titled, Engaging Older Adults in the National Cancer Institute Clinical Trials Network: Challenges and Opportunities, recommended study designs and design elements that could improve accrual of older adults in National Cancer Institute-funded clinical trials. These include trials that are specifically designed to enroll older adults, trials that include a cohort of older patients (parallel cohort, stratified cohort, or embedded cohort), and trials with pragmatic design elements to facilitate enrollment of older adults. This manuscript provides brief descriptions of the recommended designs, examples of successful trials, and considerations for implementation of these designs. As with any clinical trial, the scientific questions and trial objectives should drive the study design, the selection of endpoints and intervention, and eligibility criteria. When designing trials that include older adults, the heterogeneity of fitness levels is an important consideration as fitness can influence accrual rates and outcomes. Appropriately incorporating geriatric assessments can help identify the optimal subset of older patients for inclusion and minimize selection bias. Incorporating pragmatic design elements to reduce the burden on trial participants as well as on accruing sites and retaining essential elements to ensure that the main goal of the trial can be accomplished can enhance enrollment without compromising the integrity of trials.

尽管65岁及以上的成年人占癌症患者的绝大多数,但他们在癌症临床试验中的代表性不足,导致缺乏具有代表性的数据来指导该患者群体的循证治疗决策。试验设计工作组,作为研讨会的一部分,召集老年人参与国家癌症研究所临床试验网络:挑战和机遇,推荐了研究设计和设计元素,可以提高老年人在国家癌症研究所资助的临床试验中的累积。这些试验包括专门设计入组老年人的试验,包括老年患者队列的试验(平行队列、分层队列或嵌入队列),以及具有实用设计元素以促进老年人入组的试验。这份手稿提供了推荐设计的简要描述,成功试验的例子,并考虑到这些设计的实施。与任何临床试验一样,科学问题和试验目标应该驱动研究设计、终点和干预措施的选择以及资格标准。当设计包括老年人的试验时,健康水平的异质性是一个重要的考虑因素,因为健康可以影响应计率和结果。适当地纳入老年评估有助于确定纳入的老年患者的最佳子集,并最大限度地减少选择偏差。结合实用的设计元素,以减少试验参与者的负担,并保留必要的元素,以确保试验的主要目标能够实现,可以在不损害试验完整性的情况下增加入组人数。
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引用次数: 3
Update on Enrollment of Older Adults Onto National Cancer Institute National Clinical Trials Network Trials. 老年人加入国家癌症研究所国家临床试验网络试验的最新进展。
Pub Date : 2022-12-15 DOI: 10.1093/jncimonographs/lgac017
Grace E Mishkin, Andrea M Denicoff, Ana F Best, Richard F Little

Background: Older adults are a large and growing proportion of cancer cases in the United States, but concerns persist about whether older adults are adequately represented in the cancer clinical trials that test new options for treatment and cancer care.

Methods: This paper describes adult patient enrollments by age group to the National Cancer Institute's National Clinical Trials Network (NCTN) from 2016 to 2021, compares patient enrollment by age with the estimated incident cancer population across cancer types, and explores possible associations between patient age and patient race, ethnicity, and sex.

Results: This analysis found that patients aged 18 to 69 years were overrepresented in NCTN trials, whereas patients aged 70 years and older were underrepresented compared with the estimated incident cancer population. Underrepresentation of older patients was seen across cancer types. Older patients who enrolled to NCTN trials were more likely to be non-Hispanic White than the estimated incident cancer population.

Conclusions: Compared with earlier analyses, NCTN trials are enrolling greater proportions of older adults, primarily driven by higher enrollment among patients aged 65 to 74 years. There is still significant room for improvement, however, especially among patients aged 75 years and older. Additionally, patient demographics should not be viewed in isolation: older Hispanic patients, for instance, were particularly underrepresented among patients enrolled to NCTN trials. The intersection between trial enrollment and age, race, and ethnicity warrants further study so that more targeted enrollment enhancement efforts can be developed that enhance trial diversity across demographic groups.

背景:在美国,老年人在癌症病例中所占的比例很大,而且还在不断增长,但人们一直担心,在测试新的治疗和癌症护理方案的癌症临床试验中,老年人是否得到了充分的代表。方法:本文描述了2016年至2021年美国国家癌症研究所国家临床试验网络(NCTN)按年龄组入组的成年患者,比较了按年龄入组的患者与各种癌症类型的估计发病率癌症人群,并探讨了患者年龄与患者种族、民族和性别之间可能存在的关联。结果:该分析发现,在NCTN试验中,18至69岁的患者被过度代表,而与估计的癌症发病率相比,70岁及以上的患者被低估。在各种癌症类型中,老年患者的代表性都不足。参加NCTN试验的老年患者更有可能是非西班牙裔白人,而不是估计的癌症发病率。结论:与早期分析相比,NCTN试验纳入了更大比例的老年人,主要是由于65至74岁患者的入组率较高。然而,仍有很大的改进空间,特别是在75岁及以上的患者中。此外,不应孤立地看待患者人口统计数据:例如,在参加NCTN试验的患者中,老年西班牙裔患者的代表性尤其不足。试验入组与年龄、种族和民族之间的交叉关系值得进一步研究,以便制定更有针对性的入组促进措施,增强试验在人口统计学群体中的多样性。
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引用次数: 2
Through the Lens of Patient Partners: Challenges in Accrual of Older Adults to NCI Clinical Trials. 通过患者合作伙伴的镜头:老年人对NCI临床试验的挑战。
Pub Date : 2022-12-15 DOI: 10.1093/jncimonographs/lgac022
Karlynn BrintzenhofeSzoc, Beverly Canin, Esmeralda Casas-Silva, Andrea Denicoff, Christa Braun-Inglis, Izumi Okado, Alexis Bakos

The workshop "Engaging Older Adults in Cancer Clinical Trials Conducted in the NCI Clinical Trials Network: Challenges and Opportunities" included a Patient Stakeholder Workgroup that explored the needs and concerns of older adults with cancer regarding clinical trials. To accomplish this, the workgroup conducted patient focus groups in which participants were interviewed, recorded conversations were analyzed and coded, and salient themes were identified. The focus groups identified general barriers to accrual such as complex consent forms, general communication, restrictive eligibility, nonreferrals, patient costs, cultural insensitivity, limited accessibility in community settings, and transportation issues. They also identified the influence of knowledgeable information presenters, improved care, family or caregiver support, and the desire to help others as drivers or reasons to participate in clinical trials. The workshop concluded that multi-level interventions could be used to increase the accrual of older adults to National Cancer Institute clinical trials as well as others.

研讨会“让老年人参与NCI临床试验网络进行的癌症临床试验:挑战和机遇”包括一个患者利益相关者工作组,该工作组探讨了老年癌症患者对临床试验的需求和关注。为了实现这一目标,工作组开展了患者焦点小组,对参与者进行了访谈,对记录的对话进行了分析和编码,并确定了突出的主题。焦点小组确定了累积的一般障碍,如复杂的同意书、一般沟通、限制性资格、非转诊、患者费用、文化不敏感、社区环境中有限的可及性和交通问题。他们还确定了知识渊博的信息展示者的影响,改善的护理,家庭或护理人员的支持,以及帮助他人的愿望是参与临床试验的驱动因素或原因。研讨会的结论是,多层次的干预可以用来增加老年人在国家癌症研究所临床试验以及其他方面的累积。
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引用次数: 0
Enrolling Older Adults Onto National Cancer Institute-Funded Clinical Trials in Community Oncology Clinics: Barriers and Solutions. 在社区肿瘤诊所招募老年人参加国家癌症研究所资助的临床试验:障碍和解决方案。
Pub Date : 2022-12-15 DOI: 10.1093/jncimonographs/lgac019
Judith O Hopkins, Christa Braun-Inglis, Sofia Guidice, Meg Wells, Kiran Moorthi, Jeffrey Berenberg, Diane St Germain, Supriya Mohile, Matthew F Hudson

In April 2021, the National Cancer Institute (NCI) Division of Cancer Prevention collaborated with the NCI Division of Cancer Treatment and Diagnosis to produce a virtual workshop that developed recommendations for enhancing NCI-sponsored clinical trial accrual of older adults. Prior to the workshop, a multidisciplinary group of stakeholders (eg, community oncologists, advanced practice practitioners, clinic and research staff, and patient advocates) gathered information related to accrual of older adults to clinical trials from the literature. Subsequently, a survey was conducted to detail NCI Community Oncology Research Program members' perspective on accrual barriers for this population; 305 individuals responded to the survey. Barriers to clinical trial accruals included comorbidity-attributed trial ineligibility, transportation and time issues, concern that the proposed regimen is too toxic for older adults, patient or family caregiver declined participation, and lack of trials relevant to older patients. Identified solutions included broadening clinical trial inclusion criteria, increasing the number of clinical trials specifically designed for older adults, simplifying consent forms, improving recruitment materials for older adults and their families, and facilitating transportation vouchers. At the workshop, participants, including stakeholders, used prior literature and survey results to develop recommendations, including interventions to address clinician bias, implement geriatric assessment, and promote clinician and staff engagement as mechanisms to improve accrual of older adults to clinical trials.

2021年4月,美国国家癌症研究所(NCI)癌症预防部与NCI癌症治疗和诊断部合作,举办了一个虚拟研讨会,为加强NCI赞助的老年人临床试验积累提出了建议。在研讨会之前,一个由利益相关者组成的多学科小组(例如,社区肿瘤学家、高级执业医师、临床和研究人员以及患者倡导者)从文献中收集了与老年人临床试验相关的信息。随后,进行了一项调查,详细介绍了NCI社区肿瘤研究计划成员对该人群累积障碍的看法;305人参与了调查。临床试验累积的障碍包括合并症导致的试验不合格、运输和时间问题、对拟议方案对老年人毒性过大的担忧、患者或家庭照顾者拒绝参与,以及缺乏与老年患者相关的试验。确定的解决办法包括扩大临床试验纳入标准,增加专门为老年人设计的临床试验数量,简化同意表格,改进老年人及其家庭的招募材料,以及便利交通券。在研讨会上,包括利益相关者在内的参与者利用先前的文献和调查结果制定建议,包括解决临床医生偏见的干预措施,实施老年评估,促进临床医生和工作人员的参与,作为改善老年人临床试验的机制。
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引用次数: 2
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Journal of the National Cancer Institute. Monographs
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