Kalam F, James DL, Li YR
… +6 more, Coleman MF, Kiesel VA, Cespedes Feliciano EM, Hursting SD, Sears DD, Kleckner AS
J Natl Cancer Inst Monogr
· 2023 May · PMID 37139971
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Intermittent fasting entails restricting food intake during specific times of day, days of the week, religious practice, or surrounding clinically important events. Herein, the metabolic and circadian rhythm mechanisms u...Intermittent fasting entails restricting food intake during specific times of day, days of the week, religious practice, or surrounding clinically important events. Herein, the metabolic and circadian rhythm mechanisms underlying the proposed benefits of intermittent fasting for the cancer population are described. We summarize epidemiological, preclinical, and clinical studies in cancer published between January 2020 and August 2022 and propose avenues for future research. An outstanding concern regarding the use of intermittent fasting among cancer patients is that fasting often results in caloric restriction, which can put patients already prone to malnutrition, cachexia, or sarcopenia at risk. Although clinical trials do not yet provide sufficient data to support the general use of intermittent fasting in clinical practice, this summary may be useful for patients, caregivers, and clinicians who are exploring intermittent fasting as part of their cancer journey for clinical outcomes and symptom management.
Gilmore LA, Parry TL, Thomas GA
… +1 more, Khamoui AV
J Natl Cancer Inst Monogr
· 2023 May · PMID 37139970
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Cachexia is a life-threatening complication of cancer that occurs in up to 80% of patients with advanced cancer. Cachexia reflects the systemic consequences of cancer and prominently features unintended weight loss and s...Cachexia is a life-threatening complication of cancer that occurs in up to 80% of patients with advanced cancer. Cachexia reflects the systemic consequences of cancer and prominently features unintended weight loss and skeletal muscle wasting. Cachexia impairs cancer treatment tolerance, lowers quality of life, and contributes to cancer-related mortality. Effective treatments for cancer cachexia are lacking despite decades of research. High-throughput omics technologies are increasingly implemented in many fields including cancer cachexia to stimulate discovery of disease biology and inform therapy choice. In this paper, we present selected applications of omics technologies as tools to study skeletal muscle alterations in cancer cachexia. We discuss how comprehensive, omics-derived molecular profiles were used to discern muscle loss in cancer cachexia compared with other muscle-wasting conditions, to distinguish cancer cachexia from treatment-related muscle alterations, and to reveal severity-specific mechanisms during the progression of cancer cachexia from early toward severe disease.
Mishkin GE, Denicoff AM, Best AF
… +1 more, Little RF
J Natl Cancer Inst Monogr
· 2022 Dec · PMID 36519819
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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 opt...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.
Le-Rademacher J, Mohile S, Unger J
… +13 more, Hudson MF, Foster J, Lichtman S, Perlmutter J, Dotan E, Extermann M, Dodd K, Tew W, Klepin H, Wildes TM, Sedrak MS, Jatoi A, Little RF
J Natl Cancer Inst Monogr
· 2022 Dec · PMID 36519818
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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 decisi...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.
BrintzenhofeSzoc K, Canin B, Casas-Silva E
… +4 more, Denicoff A, Braun-Inglis C, Okado I, Bakos A
J Natl Cancer Inst Monogr
· 2022 Dec · PMID 36519817
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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 o...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.
Magnuson A, Van der Walde N, McKoy JM
… +5 more, Wildes TM, Wong ML, Le-Rademacher J, Little RF, Klepin HD
J Natl Cancer Inst Monogr
· 2022 Dec · PMID 36519816
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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 geriatri...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.
Hopkins JO, Braun-Inglis C, Guidice S
… +6 more, Wells M, Moorthi K, Berenberg J, St Germain D, Mohile S, Hudson MF
J Natl Cancer Inst Monogr
· 2022 Dec · PMID 36519815
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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 enhan...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.
Kimmick G, Sedrak MS, Williams G
… +9 more, McCleary NJ, Rosko AE, Berenberg JL, Freedman RA, Smith ML, Ahmed A, Muss HB, Chow S, Dale W
J Natl Cancer Inst Monogr
· 2022 Dec · PMID 36519814
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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 countr...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.
J Natl Cancer Inst Monogr
· 2022 Jul · PMID 35788383
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BACKGROUND: Health economics research is an integral part of the transdisciplinary research supported by the National Cancer Institute (NCI). To better understand NCI activities in this area, we conducted a portfolio ana...BACKGROUND: Health economics research is an integral part of the transdisciplinary research supported by the National Cancer Institute (NCI). To better understand NCI activities in this area, we conducted a portfolio analysis of funded NCI grants including health economics research. METHODS: We examined all competitive grants funded by NCI from fiscal years 2015 to 2020 that included economic analyses or outcomes. Grant titles, abstracts, and specific aims were independently reviewed by 2 study team members; content of included grants was then coded for analysis. RESULTS: A total 212 grants were identified from searches; 146 of these included economic analyses and were included in the portfolio analysis. These 146 grants represent approximately 0.9% of all NCI competitively funded grants awarded 2015-2020. Of these grants, 100 were R01 awards, representing approximately 2.4% of all NCI R01 grants funded 2015-2020. The most common study type was interventional randomized controlled-trial, followed by simulation or model. Screening and prevention were the most frequent grant cancer continuum topic; survivorship was included in only 16 grants (11.0%). Cost-effectiveness analysis was the most frequently listed economic outcome (97 grants, 66.4%), whereas policy impact (20 grants, 13.7%) and financial hardship (15 grants, 10.3%) were less-frequently included economic outcomes. However, economic outcomes differed by cancer control continuum topic, with financial hardship being included in a greater proportion of treatment and survivorship grants. CONCLUSIONS: Although relatively small, the NCI portfolio of funded grants including economic analyses is diverse, covering a range of cancer types, methods, and economic outcomes, and increasing over time.
J Natl Cancer Inst Monogr
· 2022 Jul · PMID 35788382
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The goals of the "Future of Cancer Health Economics Research" virtual conference were to identify challenges, gaps, and unmet needs for conducting cancer health economics research; and develop suggestions and ideas to ad...The goals of the "Future of Cancer Health Economics Research" virtual conference were to identify challenges, gaps, and unmet needs for conducting cancer health economics research; and develop suggestions and ideas to address these challenges and to support the development of this field. The conference involved multiple presentations and panels featuring several key themes, including data limitations and fragmentation; improving research methods; role and impacts of structural and policy factors; and the transdisciplinary nature of this field. The conference also highlighted emerging areas such as communicating results with nonresearchers; balancing data accessibility and data security; emphasizing the needs of trainees; and including health equity as a focus in cancer health economics research. From this conference, it is clear that cancer health economics research can have substantial impacts on how cancer care is delivered and how related health-care policies are developed and implemented. To support further growth and development, this field should continue to welcome individuals from multiple disciplines and enhance opportunities for training in economics and in analytic methods and perspectives from across the social and clinical sciences. Researchers should continue to engage with diverse stakeholders throughout the cancer community, building collaborations and focusing on the goal of improving health and well-being.
Health economics research, defined as research that evaluates how patients, health-care providers, and governments make health-care decisions using economic theory, models, and empirical techniques, requires broad domain...Health economics research, defined as research that evaluates how patients, health-care providers, and governments make health-care decisions using economic theory, models, and empirical techniques, requires broad domains of knowledge that are not fully encompassed by a single discipline. Collaboration between disciplines provides different perspectives on problems, creates more comprehensive research questions, allows for more complex understanding of multifaceted determinants and processes, and thus, provides more realistic recommendations to address difficult questions of health economics. Realizing the importance of collaboration, the National Cancer Institute virtual conference on the Future of Cancer Health Economics included an interactive panel exploring how to foster effective collaborations in cancer health economics research. This manuscript summarizes the panel and participants' discussion regarding the value, barriers, and potential facilitators to transdisciplinary collaboration within health economics research.
Doria-Rose VP, Breen N, Brown ML
… +6 more, Feuer EJ, Geiger AM, Kessler L, Lipscomb J, Warren JL, Yabroff KR
J Natl Cancer Inst Monogr
· 2022 Jul · PMID 35788380
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With increased attention to the financing and structure of healthcare, dramatic increases in the cost of diagnosing and treating cancer, and corresponding disparities in access, the study of healthcare economics and deli...With increased attention to the financing and structure of healthcare, dramatic increases in the cost of diagnosing and treating cancer, and corresponding disparities in access, the study of healthcare economics and delivery has become increasingly important. The Healthcare Delivery Research Program (HDRP) in the Division of Cancer Control and Population Sciences at the National Cancer Institute (NCI) was formed in 2015 to provide a hub for cancer-related healthcare delivery and economics research. However, the roots of this program trace back much farther, at least to the formation of the NCI Division of Cancer Prevention and Control in 1983. The creation of a division focused on understanding and explaining trends in cancer morbidity and mortality was instrumental in setting the direction of cancer-related healthcare delivery and health economics research over the subsequent decades. In this commentary, we provide a brief history of health economics and healthcare delivery research at NCI, describing the organizational structure and highlighting key initiatives developed by the division, and also briefly discuss future directions. HDRP and its predecessors have supported the growth and evolution of these fields through the funding of grants and contracts; the development of data, tools, and other research resources; and thought leadership including stimulation of research on previously understudied topics. As the availability of new data, methods, and computing capacity to evaluate cancer-related healthcare delivery and economics expand, HDRP aims to continue to support this growth and evolution.
J Natl Cancer Inst Monogr
· 2022 Jul · PMID 35788379
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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 condition...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.
J Natl Cancer Inst Monogr
· 2022 Jul · PMID 35788378
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Although a broad range of data resources have played a key role in the substantial achievements of cancer health economics research, there are now needs for more comprehensive data that represent a fuller picture of the...Although a broad range of data resources have played a key role in the substantial achievements of cancer health economics research, there are now needs for more comprehensive data that represent a fuller picture of the cancer care experience. In particular, researchers need information that represents more diverse populations; includes more clinical details; and provides greater context on individual- and neighborhood-level factors that can affect cancer prevention, screening, treatment, and survivorship, including measures of financial health or toxicity, health-related social needs, and social determinants of health. This article highlights 3 critical topics for cancer health economics research: the future of the National Cancer Institute's Surveillance, Epidemiology, and End Results-Centers for Medicare & Medicaid Services-linked data resources; use of social media data for cancer outcomes research; and multi-site-linked electronic health record data networks. These 3 topics represent different approaches to enhance data resources, linkages, and infrastructures and are complementary strategies to provide more complete information on activities involved in and factors affecting the cancer control continuum. These and other data resources will assist researchers in examining the complex and nuanced questions now at the forefront of cancer health economics research.
Chino F, Carroll A, Sanger-Katz M
… +2 more, Dusetzina SB, Zafar SY
J Natl Cancer Inst Monogr
· 2022 Jul · PMID 35788377
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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 Ec...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.
Ekwueme DU, Halpern MT, Chesson HW
… +6 more, Ashok M, Drope J, Hong YR, Maciosek M, Pesko MF, Kenkel DS
J Natl Cancer Inst Monogr
· 2022 Jul · PMID 35788376
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In the past 2 decades, the demand for information on health economics research to guide health care decision making has substantially increased. Studies have provided evidence that eliminating or reducing tobacco use; ea...In the past 2 decades, the demand for information on health economics research to guide health care decision making has substantially increased. Studies have provided evidence that eliminating or reducing tobacco use; eating a healthy diet, including fruit and vegetables; being physically active; reducing alcohol consumption; avoiding ultraviolet radiation; and minimizing exposure to environmental and occupational carcinogenic agents should substantially reduce cancer incidence in the population. The benefits of these primary prevention measures in reducing cancer incidence are not instantaneous. Therefore, health economics research has an important role to play in providing credible information to decision makers on the health and economic benefits of primary prevention. This article provides an overview of health economics research related to primary prevention of cancer. We addressed the following questions: 1) What are the gaps and unmet needs for performing health economics research focused on primary prevention of cancer? 2) What are the challenges and opportunities to conducting health economics research to evaluate primary prevention of cancer? and 3) What are the future directions for enhancing health economics research on primary prevention of cancer? Modeling primary prevention of cancer is often difficult given data limitations, long delays before the policy or intervention is effective, possible unintended effects of the policy or intervention, and the necessity of outside expertise to understand key inputs or outputs to the modeling. Despite these challenges, health economics research has an important role to play in providing credible information to decision makers on the health and economic benefits of primary prevention of cancer.