Pub Date : 2023-05-04DOI: 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.
{"title":"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.","authors":"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","doi":"10.1093/jncimonographs/lgad005","DOIUrl":"10.1093/jncimonographs/lgad005","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":73988,"journal":{"name":"Journal of the National Cancer Institute. Monographs","volume":"2023 61","pages":"149-157"},"PeriodicalIF":0.0,"publicationDate":"2023-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10157760/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10101614","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}
Pub Date : 2023-05-04DOI: 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.
{"title":"Linking social and built environmental factors to leisure-time physical activity in rural cancer survivors.","authors":"Courtney J Stevens, Yue Liao, Minxing Chen, Natalia I Heredia, Hannah Arem, Jasmine Sukumar, Lenat Joffe, Kathryn H Schmitz, Scherezade K Mama","doi":"10.1093/jncimonographs/lgad004","DOIUrl":"10.1093/jncimonographs/lgad004","url":null,"abstract":"<p><strong>Background: </strong>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).</p><p><strong>Method: </strong>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.</p><p><strong>Results: </strong>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).</p><p><strong>Conclusions: </strong>Social and built environmental factors were consistently linked with LTPA and provide context for multilevel interventions promoting LTPA in RCS.</p>","PeriodicalId":73988,"journal":{"name":"Journal of the National Cancer Institute. Monographs","volume":"2023 61","pages":"125-132"},"PeriodicalIF":0.0,"publicationDate":"2023-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10157784/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9870254","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}
Pub Date : 2022-12-15DOI: 10.1093/jncimonographs/lgac018
{"title":"Correction to: Enhancing Health Equity Through Cancer Health Economics Research.","authors":"","doi":"10.1093/jncimonographs/lgac018","DOIUrl":"https://doi.org/10.1093/jncimonographs/lgac018","url":null,"abstract":"","PeriodicalId":73988,"journal":{"name":"Journal of the National Cancer Institute. Monographs","volume":"2022 60","pages":"159"},"PeriodicalIF":0.0,"publicationDate":"2022-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9753218/pdf/lgac018.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10728333","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}
Pub Date : 2022-12-15DOI: 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.
{"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}
Pub Date : 2022-12-15DOI: 10.1093/jncimonographs/lgac020
Diane St Germain, Supriya G Mohile
{"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}
Pub Date : 2022-12-15DOI: 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.
{"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}
Pub Date : 2022-12-15DOI: 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.
{"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}
Pub Date : 2022-12-15DOI: 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.
{"title":"Update on Enrollment of Older Adults Onto National Cancer Institute National Clinical Trials Network Trials.","authors":"Grace E Mishkin, Andrea M Denicoff, Ana F Best, 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}
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.
{"title":"Through the Lens of Patient Partners: Challenges in Accrual of Older Adults to NCI Clinical Trials.","authors":"Karlynn BrintzenhofeSzoc, Beverly Canin, Esmeralda Casas-Silva, Andrea Denicoff, Christa Braun-Inglis, Izumi Okado, 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}
Pub Date : 2022-12-15DOI: 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.
{"title":"Enrolling Older Adults Onto National Cancer Institute-Funded Clinical Trials in Community Oncology Clinics: Barriers and Solutions.","authors":"Judith O Hopkins, Christa Braun-Inglis, Sofia Guidice, Meg Wells, Kiran Moorthi, Jeffrey Berenberg, Diane St Germain, Supriya Mohile, 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}