Journal of the National Cancer Institute. Monographs最新文献

{"title":"Integrating Geriatric Assessment Measures into National Cancer Institute Clinical Trials.","authors":"Allison Magnuson, Noam Van der Walde, June M McKoy, Tanya M Wildes, Melisa L Wong, Jennifer Le-Rademacher, Richard F Little, Heidi D Klepin","doi":"10.1093/jncimonographs/lgac021","DOIUrl":"https://doi.org/10.1093/jncimonographs/lgac021","url":null,"abstract":"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.","PeriodicalId":73988,"journal":{"name":"Journal of the National Cancer Institute. Monographs","volume":"2022 60","pages":"142-150"},"PeriodicalIF":0.0,"publicationDate":"2022-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9949568/pdf/lgac021.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9334188","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preface: Engaging Older Adults in Cancer Clinical Trials Conducted in the National Cancer Institute Clinical Trials Network: Opportunities to Enhance Accrual.","authors":"Diane St Germain, Supriya G Mohile","doi":"10.1093/jncimonographs/lgac020","DOIUrl":"https://doi.org/10.1093/jncimonographs/lgac020","url":null,"abstract":"","PeriodicalId":73988,"journal":{"name":"Journal of the National Cancer Institute. Monographs","volume":"2022 60","pages":"107-110"},"PeriodicalIF":0.0,"publicationDate":"2022-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9949569/pdf/lgac020.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9334187","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Infrastructure to Support Accrual of Older Adults to National Cancer Institute Clinical Trials.","authors":"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","doi":"10.1093/jncimonographs/lgac025","DOIUrl":"10.1093/jncimonographs/lgac025","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":73988,"journal":{"name":"Journal of the National Cancer Institute. Monographs","volume":"2022 60","pages":"151-158"},"PeriodicalIF":0.0,"publicationDate":"2022-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9753220/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9572025","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Trial Design Considerations to Increase Older Adult Accrual to National Cancer Institute Clinical Trials.","authors":"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","doi":"10.1093/jncimonographs/lgac023","DOIUrl":"10.1093/jncimonographs/lgac023","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":73988,"journal":{"name":"Journal of the National Cancer Institute. Monographs","volume":"2022 60","pages":"135-141"},"PeriodicalIF":0.0,"publicationDate":"2022-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9949574/pdf/lgac023.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9511436","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Update on Enrollment of Older Adults Onto National Cancer Institute National Clinical Trials Network Trials.","authors":"Grace E Mishkin,&nbsp;Andrea M Denicoff,&nbsp;Ana F Best,&nbsp;Richard F Little","doi":"10.1093/jncimonographs/lgac017","DOIUrl":"https://doi.org/10.1093/jncimonographs/lgac017","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":73988,"journal":{"name":"Journal of the National Cancer Institute. Monographs","volume":"2022 60","pages":"111-116"},"PeriodicalIF":0.0,"publicationDate":"2022-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9949562/pdf/lgac017.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9319602","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Through the Lens of Patient Partners: Challenges in Accrual of Older Adults to NCI Clinical Trials.","authors":"Karlynn BrintzenhofeSzoc,&nbsp;Beverly Canin,&nbsp;Esmeralda Casas-Silva,&nbsp;Andrea Denicoff,&nbsp;Christa Braun-Inglis,&nbsp;Izumi Okado,&nbsp;Alexis Bakos","doi":"10.1093/jncimonographs/lgac022","DOIUrl":"https://doi.org/10.1093/jncimonographs/lgac022","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":73988,"journal":{"name":"Journal of the National Cancer Institute. Monographs","volume":"2022 60","pages":"125-134"},"PeriodicalIF":0.0,"publicationDate":"2022-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9949584/pdf/lgac022.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9572026","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enrolling Older Adults Onto National Cancer Institute-Funded Clinical Trials in Community Oncology Clinics: Barriers and Solutions.","authors":"Judith O Hopkins,&nbsp;Christa Braun-Inglis,&nbsp;Sofia Guidice,&nbsp;Meg Wells,&nbsp;Kiran Moorthi,&nbsp;Jeffrey Berenberg,&nbsp;Diane St Germain,&nbsp;Supriya Mohile,&nbsp;Matthew F Hudson","doi":"10.1093/jncimonographs/lgac019","DOIUrl":"https://doi.org/10.1093/jncimonographs/lgac019","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":73988,"journal":{"name":"Journal of the National Cancer Institute. Monographs","volume":"2022 60","pages":"117-124"},"PeriodicalIF":0.0,"publicationDate":"2022-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9753219/pdf/lgac019.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9521052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cancer Survivorship and Supportive Care Economics Research: Current Challenges and Next Steps.","authors":"Lauren Hersch Nicholas,&nbsp;Amy J Davidoff,&nbsp;David H Howard,&nbsp;Nancy L Keating,&nbsp;Debra P Ritzwoller,&nbsp;K Robin Yabroff,&nbsp;Cathy J Bradley","doi":"10.1093/jncimonographs/lgac004","DOIUrl":"https://doi.org/10.1093/jncimonographs/lgac004","url":null,"abstract":"<p><strong>Background: </strong>Rapid growth in the number of cancer survivors raises numerous questions about health and economic outcomes among survivors along with their families, caregivers, and employers. Health economics theory and methods can contribute to many open questions to improve survivorship.</p><p><strong>Methods: </strong>In this paper, we review key areas where more research is needed and describe strategies for improving data infrastructure, research funding, and capacity building to strengthen survivorship health economics research.</p><p><strong>Conclusions: </strong>Health economics has broadened an understanding of key supply- and demand-side factors that promote cancer survivorship. To ensure necessary research in survivorship health economics moving forward, we recommend dedicated funding, inclusion of health economics outcomes in primary data collection, and investments in secondary data sets.</p>","PeriodicalId":73988,"journal":{"name":"Journal of the National Cancer Institute. Monographs","volume":"2022 59","pages":"57-63"},"PeriodicalIF":0.0,"publicationDate":"2022-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9609250/pdf/lgac004.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9671877","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"How Data Security Concerns Can Hinder Natural Experiment Research: Background and Potential Solutions.","authors":"Michael F Pesko","doi":"10.1093/jncimonographs/lgac007","DOIUrl":"10.1093/jncimonographs/lgac007","url":null,"abstract":"<p><p>Health economists conducting cancer-related research often use geocoded data to analyze natural experiments generated by policy changes. These natural experiments can provide causal interpretation under certain conditions. Despite public health benefit of this rigorous natural experiment methodology, data providers are often reluctant to provide geocoded data because of confidentiality concerns. This paper provides an example of the value of natural experiments from e-cigarette research and shows how this research was hindered by security concerns. Although the tension between data access and security will not be resolved overnight, this paper offers 3 recommendations: 1) provide public access to aggregated data at area levels (eg, state) where possible; 2) approve projects with enough time to allow for publication in journals with lengthy peer-review times; and 3) improve communication and transparency between data providers and the research community. The Foundations for Evidence Based Policymaking Act of 2018 also presents a unique opportunity for improving the ability of researchers to use geocoded data for natural experiment research without compromising data security.</p>","PeriodicalId":73988,"journal":{"name":"Journal of the National Cancer Institute. Monographs","volume":"2022 59","pages":"89-94"},"PeriodicalIF":0.0,"publicationDate":"2022-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9255918/pdf/lgac007.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9890973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Communicating Research to Non-Researcher Audiences: A Panel Discussion From the National Cancer Institute's Future of Cancer Health Economics Research Conference.","authors":"Fumiko Chino,&nbsp;Aaron Carroll,&nbsp;Margot Sanger-Katz,&nbsp;Stacie B Dusetzina,&nbsp;S Yousuf Zafar","doi":"10.1093/jncimonographs/lgab021","DOIUrl":"https://doi.org/10.1093/jncimonographs/lgab021","url":null,"abstract":"<p><p>With rising health-care costs and increasing patient financial strain, health economics research has never been more relevant to the lay public. This manuscript summarizes the discussion from the \"Communicating Health Economics Research to Non-Researcher Audiences\" expert panel and highlights the foundations of good health/science communication, distilling your work into a newsworthy headline, and communication concerns in specific scenarios. It also provides \"dos and don'ts\" for promoting your research to the news media and a list of resources on interacting with the press for further study.</p>","PeriodicalId":73988,"journal":{"name":"Journal of the National Cancer Institute. Monographs","volume":"2022 59","pages":"64-67"},"PeriodicalIF":0.0,"publicationDate":"2022-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9255936/pdf/lgab021.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10129075","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}