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Preface: Engaging Older Adults in Cancer Clinical Trials Conducted in the National Cancer Institute Clinical Trials Network: Opportunities to Enhance Accrual

Preface: Engaging Older Adults in Cancer Clinical Trials Conducted in the National Cancer... Downloaded from https://academic.oup.com/jncimono/article/2022/60/107/6908743 by DeepDyve user on 20 December 2022 J Natl Cancer Inst Monogr (2022) 2022(60): lgac020 https://doi.org/10.1093/jncimonographs/lgac020 Monograph MO NOG R AP H Preface: Engaging Older Adults in Cancer Clinical Trials Conducted in the National Cancer Institute Clinical Trials Network: Opportunities to Enhance Accrual 1 2, Diane St. Germain, RN, MS, Supriya G. Mohile, MD, MS * 1 2 Division of Cancer Prevention, Community Oncology & Prevention Trials Research Group, National Cancer Institute, Bethesda, MD, USA; and Departments of Medicine and Surgery, University of Rochester Medical Center, Rochester, NY, USA *Correspondence to: Supriya G. Mohile, MD, MS, Departments of Medicine and Surgery, University of Rochester Medical Center, 601 Elmwood Ave, Box 704, Rochester, NY 14642, USA (e-mail: supriya_mohile@urmc.rochester.edu). Barriers to the accrual of older adults with cancer onto both the Alliance for Clinical Trials in Oncology. More than 1000 therapeutic and cancer control intervention clinical trials are members participated representing a diverse group of clinicians well described in the literature. The reasons for underrepresen- and staff members across this NCI-funded network. More than tation of older adults onto cancer clinical trials are complex one-third of members felt that older adults should represent because barriers stem from multiple systems that need to inter- most clinical trial participants. Strategies to improve accrual act efficiently to support accrual. These barriers can include included improving study design such as expansion cohorts for oncology and clinician teams (eg, clinician bias), study design older adults, dedicating trials for more vulnerable and frail older (eg, eligibility restrictions), infrastructure (eg, need for extensive adults, reducing exclusion criteria for all trials especially related travel and/or multiple appointments), and patient and caregiver to comorbidity restrictions, and increasing research to develop factors. A comprehensive systematic review by Sedrak et al. (1) system-level improvements for recruitment. A qualitative anal- on behalf of the Cancer and Aging Research Group (CARG) pro- ysis by Sedrak et al. (5) identified differing perceptions to vided a strong foundation for the workshop. Of 8691 articles accrual of older adults by oncologist based on location of prac- screened for eligibility, only 13 met the inclusion criteria for the tice (community vs academic). Whereas community oncologists study questions related to barriers and interventions related to were more likely to report barriers related to patient and care- accrual of older adults in clinical trials. The investigators con- giver hesitation to accrual, academic oncologists reported clini- cluded that there is a need for high-quality research that exam- cian bias and limited support as the most common barriers. ines barriers to accrual at multiple levels. Further, only 1 of the This prior work highlights the barriers to enrolling older studies evaluated an intervention to improve accrual to adults to clinical trials and importantly underscores the paucity National Cancer Institute (NCI) clinical trials; this trial, con- of interventions to address them. Emanating from the SM ducted in the Cancer and Leukemia Group B network, although Cancer Moonshot Network for Direct Patient Engagement negative, did demonstrate a high-priority need to better under- Implementation Team, a one and a half day workshop was held stand prioritization of cancer clinical trials for the older patient to develop recommendations to increase accrual of older adults population at the national level (2). In 2021, a study conducted to NCI-supported clinical trials. Participants included oncolo- by the NCI demonstrated that a clinical trial screening tool can gists, nurse scientists, advance practice nurses, gerontologists identify barriers to accrual to cancer clinical trials (3). Patients and geriatricians, statisticians, clinical trialists, and patient aged 70 years and older were more likely to not be enrolled onto partners. An emphasis was placed on engaging patient partners trials after screening; in addition, older adults were more likely to gain a better understanding of their perspective and how to have comorbidities that prevented accrual because of eligibil- medical personnel can facilitate their participation in clinical ity restrictions. Two studies have evaluated the perceptions of trials. The goals of the workshop were to community oncologists with regard to accrual of older adults to 1) engage physicians to address barriers to enrollment of cancer clinical trials. The first, by Freedman et al. (4), reported older adults to clinical trials; results from a survey administered to oncologists affiliated with Received: June 15, 2022; Revised: August 3, 2022; Accepted: September 11, 2022 Published by Oxford University Press 2022. This work is written by (a) US Government employee(s) and is in the public domain in the US. 107 Downloaded from https://academic.oup.com/jncimono/article/2022/60/107/6908743 by DeepDyve user on 20 December 2022 108 | J Natl Cancer Inst Monogr, 2022, Vol. 2022, No. 60 Table 1. Members of working groups Study design Geriatric assessment Infrastructure Stakeholders Rich Little (NCI lead) Allison Magnuson Cristina Russo (NCI lead) Alexis Bakos (NCI lead) Jennifer Le-Rademacher (lead) Harvey Cohen Grace Mishkin (NCI co-lead) Carol Weil Efrat Dotan Stuart Lichtman William Dale Judy Hopkins Barbara Radziszewska Aminah Jatoi Mina Sedrak Worta McCaskill-Stevens William Tew Martine Extermann Rachel Freedman Beverly Canin Joseph Unger Melisa Wong Hyman Muss Andrea Denicoff Heidi Klepin Tanya Wildes Grant Williams Harpreet Singh (FDA) Naom VanderWalde Nadine McCleary Jackson Liz Brem Gretchen Kimmick Brea Lipp a a Selina Chow Karylnn BrintzenhofeSzoc Peggy Wisher Jeff Berenberg Judy Hopkins (co-lead) Jim Atkins Christa Braun-Inglis External to planning committee. FDA ¼ Food and Drug Administration; NCI ¼ National Cancer Institute. 2) engage patients to enhance our understanding of the bar- control clinical trials offered through the NCORP network. A sur- riers to enrollment of older adults to clinical trials and dis- vey developed by a team of investigators in cancer and aging, cuss ways to overcome them; community oncologists, and research staff from the University of Rochester Cancer Center NCORP Research Base was adminis- 3) develop consensus regarding the research priorities for the use of geriatric assessment (GA) to enhance precision tered by the NCI to NCORP Community Affiliate sites. The more than 300 members of the NCORP network that participated in enrollment and treatment of older adult patients on NCI- sponsored clinical trials; and the survey identified unique barriers and solutions and commu- nicated recommendations for interventions to improve accrual. 4) build consensus around the methods to integrate compre- This work by Hopkins et al. (7) was presented at the workshop hensive GA in future trials, with the long-term objective of and is published in this Monograph. having these trial results provide evidence to use compre- Another major goal of the workshop was to elicit input hensive GA to inform decision making for cancer treat- from patients and caregivers themselves to extend understand- ments in older adults, both in routine care and in future ing of barriers and possible solutions for improving accrual of trials. older adults to cancer clinical trials. Patients and caregivers A planning group comprised of experts in geriatric oncology who have fostered engagement in NCI-funded cooperative and clinical trial design and accrual was formed to develop groups as well as in SCOREboard, an older patient with cancer the workshop format and agenda. The group included represen- and caregiver group affiliated with the CARG, were key partici- tation from the NCI Community Oncology Research Program pants in all of the activities to prepare for the workshop and (NCORP) Research Bases, Community Sites, Minority/Underserved at the workshop itself. Also presented at the workshop and Community sites, and CARG Patient Partners (Table 1). The group published in this Monograph by BrintzenhofeSzoc et al. are decided on 4 main areas of focus: stakeholder engagement, clini- results from focus groups with older patients with cancer and cal trial design, GA, and infrastructure to support accrual. caregivers that elucidated key themes related to accrual Working groups focused on these 4 areas were formed to review barriers. the literature, identify current efforts to avoid duplication, Building on prior recommendations from the CARG (6) and develop approaches to address identified gaps, and suggest the American Society of Clinical Oncology (8), the study design speakers and topics (see Table 2 for specific charges of each working group reviewed study design options that could help group). The working groups presented their recommendations at increase accrual of older populations and those who have the workshop so the focus could be on the discussion of action- aging-related conditions. To provide recommendations, the able interventions that could be further studied or implemented group reviewed published trials and those in progress that have to address barriers to accrual to older adults with cancer. used novel designs. These recommendations and trial examples Updated accrual data to NCI treatment trials was provided to presented and published in this Monograph by LeRademacher the working groups, which provided an understanding of accrual et al. can serve as a resource to investigators and reviewers at by age group and cancer type. This data was last published 10 years the cooperative groups and NCI as they consider new concepts. ago byHurriaet al. (6) in a publication that described a conference Investigators and reviewers should strive to evaluate and focused on the design of therapeutic trials for older adults. The encourage the best options to foster adequate representation of updated data, which was also presented at the workshop and is older adults. published in this Monograph (Mishkin et al.), demonstrated The GA working group focused on integration of GA into improvement in enrollment of older adults to NCI-supported ther- NCI-funded cancer clinical trials. GA can include comprehen- apeutic trials; however, there is an ongoing need for improvement, sive assessment of health status using validated measures that particularly for individuals aged 75 years and older. can guide decision making for cancer treatment and manage- The stakeholder group conducted an evaluation to better ment for aging-related conditions or shorter measurement tools understand the perceptions of community oncology teams that can capture specific aging-related conditions (eg, comor- (clinicians and research staff) to accrual of older adults to cancer bidity, disability). A manuscript published in this Monograph Downloaded from https://academic.oup.com/jncimono/article/2022/60/107/6908743 by DeepDyve user on 20 December 2022 D. St. Germain and S. G. Mohile |109 Table 2. Charge of working groups Study design Geriatric assessment Infrastructure Stakeholders Consider trial designs that promote Use of geriatric assessment in Develop a roadmap from Join Study Design and enrollment of older adults (eg, clinical trials; identify research conceptualization of Infrastructure group calls cohort designs, extended cohorts, gaps research question to dis- as able parallel cohorts, less fit older adults), semination of results Define stakeholder stratification by vulnerability Necessary resources Identify modifiable accrual Consider endpoints for fit vs unfit Consideration of the barriers from each stake- individuals older adult throughout holder perspective the process Inclusion of a recruit- ment plan Describe resources available to investigators for how they can access experts with aging expertise Describe design approaches for vul- Identify best approaches and Identify infrastructure Identify interventions that nerable individuals (those who can- measures to define fitness and needs to perform com- can address the identified not be defined as fit or frail) frailty to enroll in a clinical trial prehensive geriatric barriers to enhance and methods to develop and val- assessment accrual of older adults to idate objective measures NCI-sponsored clinical trials Use technology and tele- Address clinician biases health to engage older toward enrolling older adults in clinical research adults to clinical trials Consider approaches to Identify patient needs and accrue racial and ethnic strategies to develop minority older adults and interventions to address those from rural areas trial accrual was developed by experts in trial design and GA to offer solu- Author contributions: Both SGM and DSG participated in the tions to common concerns and questions related to how to conceptualization and drafting of this manuscript. incorporate GA into clinical trials (Klepin et al). The infrastructure working group organized a framework to Acknowledgements: We would like to thank the Cancer address structural barriers that centers on developing and cen- Moonshot Implementation Team, Network for Direct Patient tralizing resources, standardizing data for reporting of NCI clini- Engagement, for their support of the workshop. We would like cal trial results, and utilizing strategic approaches to to thank Dr. Worta McCaskill Stevens for her leadership and understand and learn from what has previously been executed support of the workshop and commitment to ensuring underre- (Kimmick et al). A short checklist is included in the manuscript presented populations are enrolled to NCI clinical trials. We that could guide review processes for trial concepts. would like to thank Dr. Margaret Mooney, Dr. Richard Little, Collectively, these manuscripts offer new and innovative Grace Mishkin, and Andrea Denicoff for their support. We also solutions to common barriers to accrual. The recommendations would like to thank the planning committee who devoted hours will be disseminated to NCORP and NCI’s National Clinical of planning and their expertise: Alexis Bakos, Elizabeth Brem, Trials Network stakeholders at meetings and webinars. The NCI Beverly Canin, William Dale, Andrea Denicoff, Efrat Dotan, and NCORP Research Bases will work collaboratively to actual- Martine Extermann, Judith Hopkins, Heidi Klepin, Jennifer Le- ize the workshop recommendations with the aim to increase Rademacher, Brea Lipe, Richard Little, Worta McCaskill Stevens, accrual of older adults to NCI-supported clinical trials. Grace Mishkin, Mina Sedrak, William Tew, Joseph Unger, Tanya Wildes, Grant Williams, Melisa Wong, and Noam VanderWalde. In addition, we would like to thank the working group members Funding listed in Table 1 of the Preface. No funding was used for the workshop or to generate this manuscript. References 1. Sedrak MS, Freedman RA, Cohen HJ, et al. Older adult participation in cancer clinical trials: a systematic review of barriers and interventions. CA Cancer J Notes Clin. 2021;71(1):78–92. 2. Kimmick GG, Peterson BL, Kornblith AB, et al. Improving accrual of older per- Role of the funder: Not applicable. sons to cancer treatment trials: a randomized trial comparing an educational Disclosures: SGM and DSG have no disclosures/conflicts of intervention with standard information: CALGB 360001. J Clin Oncol. 2005; interest to report. 23(10):2201-2207. Downloaded from https://academic.oup.com/jncimono/article/2022/60/107/6908743 by DeepDyve user on 20 December 2022 110 | J Natl Cancer Inst Monogr, 2022, Vol. 2022, No. 60 3. St Germain DC, McCaskill-Stevens W. Use of a clinical trial screening tool to cancer: U13 conference recommendations. J Clin Oncol. 2014;32(24): enhance patient accrual. Cancer. 2021;127(10):1630-1637. 2587-2594. 4. Freedman RA, Dockter TJ, Lafky JM, et al. Promoting accrual of older patients 7. Hopkins JO, Braun-Inglis C, Guidice S, et al. Enrolling older adults onto with cancer to clinical trials: an alliance for clinical trials in oncology member National Cancer Institute funded clinical trials in Community Oncology clin- survey (A171602). Oncologist. 2018;23(9):1016-1023. ics: barriers and solutions. J Natl Cancer Inst Monogr. 2022; doi: 5. Sedrak MS, Mohile SG, Sun V, et al. Barriers to clinical trial enrollment of older 10.1093/jncimonographs/lgac019. adults with cancer: a qualitative study of the perceptions of community and 8. Hurria A, Levit LA, Dale W, et al.; for the American Society of Clinical academic oncologists. J Geriatr Oncol. 2020;11(2):327-334. Oncology. Improving the evidence base for treating older adults with cancer: 6. Hurria A, Dale W, Mooney M, et al.; for the Cancer and Aging Research American Society of Clinical Oncology Statement. J Clin Oncol. 2015;33(32): Group. Designing therapeutic clinical trials for older and frail adults with 3826-3833. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JNCI Monographs Oxford University Press

Preface: Engaging Older Adults in Cancer Clinical Trials Conducted in the National Cancer Institute Clinical Trials Network: Opportunities to Enhance Accrual

St. Germain, Diane; Mohile, Supriya G
JNCI Monographs , Volume 2022 (60) – Dec 15, 2022
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Oxford University Press
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Abstract

Downloaded from https://academic.oup.com/jncimono/article/2022/60/107/6908743 by DeepDyve user on 20 December 2022 J Natl Cancer Inst Monogr (2022) 2022(60): lgac020 https://doi.org/10.1093/jncimonographs/lgac020 Monograph MO NOG R AP H Preface: Engaging Older Adults in Cancer Clinical Trials Conducted in the National Cancer Institute Clinical Trials Network: Opportunities to Enhance Accrual 1 2, Diane St. Germain, RN, MS, Supriya G. Mohile, MD, MS * 1 2 Division of Cancer Prevention, Community Oncology & Prevention Trials Research Group, National Cancer Institute, Bethesda, MD, USA; and Departments of Medicine and Surgery, University of Rochester Medical Center, Rochester, NY, USA *Correspondence to: Supriya G. Mohile, MD, MS, Departments of Medicine and Surgery, University of Rochester Medical Center, 601 Elmwood Ave, Box 704, Rochester, NY 14642, USA (e-mail: supriya_mohile@urmc.rochester.edu). Barriers to the accrual of older adults with cancer onto both the Alliance for Clinical Trials in Oncology. More than 1000 therapeutic and cancer control intervention clinical trials are members participated representing a diverse group of clinicians well described in the literature. The reasons for underrepresen- and staff members across this NCI-funded network. More than tation of older adults onto cancer clinical trials are complex one-third of members felt that older adults should represent because barriers stem from multiple systems that need to inter- most clinical trial participants. Strategies to improve accrual act efficiently to support accrual. These barriers can include included improving study design such as expansion cohorts for oncology and clinician teams (eg, clinician bias), study design older adults, dedicating trials for more vulnerable and frail older (eg, eligibility restrictions), infrastructure (eg, need for extensive adults, reducing exclusion criteria for all trials especially related travel and/or multiple appointments), and patient and caregiver to comorbidity restrictions, and increasing research to develop factors. A comprehensive systematic review by Sedrak et al. (1) system-level improvements for recruitment. A qualitative anal- on behalf of the Cancer and Aging Research Group (CARG) pro- ysis by Sedrak et al. (5) identified differing perceptions to vided a strong foundation for the workshop. Of 8691 articles accrual of older adults by oncologist based on location of prac- screened for eligibility, only 13 met the inclusion criteria for the tice (community vs academic). Whereas community oncologists study questions related to barriers and interventions related to were more likely to report barriers related to patient and care- accrual of older adults in clinical trials. The investigators con- giver hesitation to accrual, academic oncologists reported clini- cluded that there is a need for high-quality research that exam- cian bias and limited support as the most common barriers. ines barriers to accrual at multiple levels. Further, only 1 of the This prior work highlights the barriers to enrolling older studies evaluated an intervention to improve accrual to adults to clinical trials and importantly underscores the paucity National Cancer Institute (NCI) clinical trials; this trial, con- of interventions to address them. Emanating from the SM ducted in the Cancer and Leukemia Group B network, although Cancer Moonshot Network for Direct Patient Engagement negative, did demonstrate a high-priority need to better under- Implementation Team, a one and a half day workshop was held stand prioritization of cancer clinical trials for the older patient to develop recommendations to increase accrual of older adults population at the national level (2). In 2021, a study conducted to NCI-supported clinical trials. Participants included oncolo- by the NCI demonstrated that a clinical trial screening tool can gists, nurse scientists, advance practice nurses, gerontologists identify barriers to accrual to cancer clinical trials (3). Patients and geriatricians, statisticians, clinical trialists, and patient aged 70 years and older were more likely to not be enrolled onto partners. An emphasis was placed on engaging patient partners trials after screening; in addition, older adults were more likely to gain a better understanding of their perspective and how to have comorbidities that prevented accrual because of eligibil- medical personnel can facilitate their participation in clinical ity restrictions. Two studies have evaluated the perceptions of trials. The goals of the workshop were to community oncologists with regard to accrual of older adults to 1) engage physicians to address barriers to enrollment of cancer clinical trials. The first, by Freedman et al. (4), reported older adults to clinical trials; results from a survey administered to oncologists affiliated with Received: June 15, 2022; Revised: August 3, 2022; Accepted: September 11, 2022 Published by Oxford University Press 2022. This work is written by (a) US Government employee(s) and is in the public domain in the US. 107 Downloaded from https://academic.oup.com/jncimono/article/2022/60/107/6908743 by DeepDyve user on 20 December 2022 108 | J Natl Cancer Inst Monogr, 2022, Vol. 2022, No. 60 Table 1. Members of working groups Study design Geriatric assessment Infrastructure Stakeholders Rich Little (NCI lead) Allison Magnuson Cristina Russo (NCI lead) Alexis Bakos (NCI lead) Jennifer Le-Rademacher (lead) Harvey Cohen Grace Mishkin (NCI co-lead) Carol Weil Efrat Dotan Stuart Lichtman William Dale Judy Hopkins Barbara Radziszewska Aminah Jatoi Mina Sedrak Worta McCaskill-Stevens William Tew Martine Extermann Rachel Freedman Beverly Canin Joseph Unger Melisa Wong Hyman Muss Andrea Denicoff Heidi Klepin Tanya Wildes Grant Williams Harpreet Singh (FDA) Naom VanderWalde Nadine McCleary Jackson Liz Brem Gretchen Kimmick Brea Lipp a a Selina Chow Karylnn BrintzenhofeSzoc Peggy Wisher Jeff Berenberg Judy Hopkins (co-lead) Jim Atkins Christa Braun-Inglis External to planning committee. FDA ¼ Food and Drug Administration; NCI ¼ National Cancer Institute. 2) engage patients to enhance our understanding of the bar- control clinical trials offered through the NCORP network. A sur- riers to enrollment of older adults to clinical trials and dis- vey developed by a team of investigators in cancer and aging, cuss ways to overcome them; community oncologists, and research staff from the University of Rochester Cancer Center NCORP Research Base was adminis- 3) develop consensus regarding the research priorities for the use of geriatric assessment (GA) to enhance precision tered by the NCI to NCORP Community Affiliate sites. The more than 300 members of the NCORP network that participated in enrollment and treatment of older adult patients on NCI- sponsored clinical trials; and the survey identified unique barriers and solutions and commu- nicated recommendations for interventions to improve accrual. 4) build consensus around the methods to integrate compre- This work by Hopkins et al. (7) was presented at the workshop hensive GA in future trials, with the long-term objective of and is published in this Monograph. having these trial results provide evidence to use compre- Another major goal of the workshop was to elicit input hensive GA to inform decision making for cancer treat- from patients and caregivers themselves to extend understand- ments in older adults, both in routine care and in future ing of barriers and possible solutions for improving accrual of trials. older adults to cancer clinical trials. Patients and caregivers A planning group comprised of experts in geriatric oncology who have fostered engagement in NCI-funded cooperative and clinical trial design and accrual was formed to develop groups as well as in SCOREboard, an older patient with cancer the workshop format and agenda. The group included represen- and caregiver group affiliated with the CARG, were key partici- tation from the NCI Community Oncology Research Program pants in all of the activities to prepare for the workshop and (NCORP) Research Bases, Community Sites, Minority/Underserved at the workshop itself. Also presented at the workshop and Community sites, and CARG Patient Partners (Table 1). The group published in this Monograph by BrintzenhofeSzoc et al. are decided on 4 main areas of focus: stakeholder engagement, clini- results from focus groups with older patients with cancer and cal trial design, GA, and infrastructure to support accrual. caregivers that elucidated key themes related to accrual Working groups focused on these 4 areas were formed to review barriers. the literature, identify current efforts to avoid duplication, Building on prior recommendations from the CARG (6) and develop approaches to address identified gaps, and suggest the American Society of Clinical Oncology (8), the study design speakers and topics (see Table 2 for specific charges of each working group reviewed study design options that could help group). The working groups presented their recommendations at increase accrual of older populations and those who have the workshop so the focus could be on the discussion of action- aging-related conditions. To provide recommendations, the able interventions that could be further studied or implemented group reviewed published trials and those in progress that have to address barriers to accrual to older adults with cancer. used novel designs. These recommendations and trial examples Updated accrual data to NCI treatment trials was provided to presented and published in this Monograph by LeRademacher the working groups, which provided an understanding of accrual et al. can serve as a resource to investigators and reviewers at by age group and cancer type. This data was last published 10 years the cooperative groups and NCI as they consider new concepts. ago byHurriaet al. (6) in a publication that described a conference Investigators and reviewers should strive to evaluate and focused on the design of therapeutic trials for older adults. The encourage the best options to foster adequate representation of updated data, which was also presented at the workshop and is older adults. published in this Monograph (Mishkin et al.), demonstrated The GA working group focused on integration of GA into improvement in enrollment of older adults to NCI-supported ther- NCI-funded cancer clinical trials. GA can include comprehen- apeutic trials; however, there is an ongoing need for improvement, sive assessment of health status using validated measures that particularly for individuals aged 75 years and older. can guide decision making for cancer treatment and manage- The stakeholder group conducted an evaluation to better ment for aging-related conditions or shorter measurement tools understand the perceptions of community oncology teams that can capture specific aging-related conditions (eg, comor- (clinicians and research staff) to accrual of older adults to cancer bidity, disability). A manuscript published in this Monograph Downloaded from https://academic.oup.com/jncimono/article/2022/60/107/6908743 by DeepDyve user on 20 December 2022 D. St. Germain and S. G. Mohile |109 Table 2. Charge of working groups Study design Geriatric assessment Infrastructure Stakeholders Consider trial designs that promote Use of geriatric assessment in Develop a roadmap from Join Study Design and enrollment of older adults (eg, clinical trials; identify research conceptualization of Infrastructure group calls cohort designs, extended cohorts, gaps research question to dis- as able parallel cohorts, less fit older adults), semination of results Define stakeholder stratification by vulnerability Necessary resources Identify modifiable accrual Consider endpoints for fit vs unfit Consideration of the barriers from each stake- individuals older adult throughout holder perspective the process Inclusion of a recruit- ment plan Describe resources available to investigators for how they can access experts with aging expertise Describe design approaches for vul- Identify best approaches and Identify infrastructure Identify interventions that nerable individuals (those who can- measures to define fitness and needs to perform com- can address the identified not be defined as fit or frail) frailty to enroll in a clinical trial prehensive geriatric barriers to enhance and methods to develop and val- assessment accrual of older adults to idate objective measures NCI-sponsored clinical trials Use technology and tele- Address clinician biases health to engage older toward enrolling older adults in clinical research adults to clinical trials Consider approaches to Identify patient needs and accrue racial and ethnic strategies to develop minority older adults and interventions to address those from rural areas trial accrual was developed by experts in trial design and GA to offer solu- Author contributions: Both SGM and DSG participated in the tions to common concerns and questions related to how to conceptualization and drafting of this manuscript. incorporate GA into clinical trials (Klepin et al). The infrastructure working group organized a framework to Acknowledgements: We would like to thank the Cancer address structural barriers that centers on developing and cen- Moonshot Implementation Team, Network for Direct Patient tralizing resources, standardizing data for reporting of NCI clini- Engagement, for their support of the workshop. We would like cal trial results, and utilizing strategic approaches to to thank Dr. Worta McCaskill Stevens for her leadership and understand and learn from what has previously been executed support of the workshop and commitment to ensuring underre- (Kimmick et al). A short checklist is included in the manuscript presented populations are enrolled to NCI clinical trials. We that could guide review processes for trial concepts. would like to thank Dr. Margaret Mooney, Dr. Richard Little, Collectively, these manuscripts offer new and innovative Grace Mishkin, and Andrea Denicoff for their support. We also solutions to common barriers to accrual. The recommendations would like to thank the planning committee who devoted hours will be disseminated to NCORP and NCI’s National Clinical of planning and their expertise: Alexis Bakos, Elizabeth Brem, Trials Network stakeholders at meetings and webinars. The NCI Beverly Canin, William Dale, Andrea Denicoff, Efrat Dotan, and NCORP Research Bases will work collaboratively to actual- Martine Extermann, Judith Hopkins, Heidi Klepin, Jennifer Le- ize the workshop recommendations with the aim to increase Rademacher, Brea Lipe, Richard Little, Worta McCaskill Stevens, accrual of older adults to NCI-supported clinical trials. Grace Mishkin, Mina Sedrak, William Tew, Joseph Unger, Tanya Wildes, Grant Williams, Melisa Wong, and Noam VanderWalde. In addition, we would like to thank the working group members Funding listed in Table 1 of the Preface. No funding was used for the workshop or to generate this manuscript. References 1. Sedrak MS, Freedman RA, Cohen HJ, et al. Older adult participation in cancer clinical trials: a systematic review of barriers and interventions. CA Cancer J Notes Clin. 2021;71(1):78–92. 2. Kimmick GG, Peterson BL, Kornblith AB, et al. Improving accrual of older per- Role of the funder: Not applicable. sons to cancer treatment trials: a randomized trial comparing an educational Disclosures: SGM and DSG have no disclosures/conflicts of intervention with standard information: CALGB 360001. J Clin Oncol. 2005; interest to report. 23(10):2201-2207. Downloaded from https://academic.oup.com/jncimono/article/2022/60/107/6908743 by DeepDyve user on 20 December 2022 110 | J Natl Cancer Inst Monogr, 2022, Vol. 2022, No. 60 3. St Germain DC, McCaskill-Stevens W. Use of a clinical trial screening tool to cancer: U13 conference recommendations. J Clin Oncol. 2014;32(24): enhance patient accrual. Cancer. 2021;127(10):1630-1637. 2587-2594. 4. Freedman RA, Dockter TJ, Lafky JM, et al. Promoting accrual of older patients 7. Hopkins JO, Braun-Inglis C, Guidice S, et al. Enrolling older adults onto with cancer to clinical trials: an alliance for clinical trials in oncology member National Cancer Institute funded clinical trials in Community Oncology clin- survey (A171602). Oncologist. 2018;23(9):1016-1023. ics: barriers and solutions. J Natl Cancer Inst Monogr. 2022; doi: 5. Sedrak MS, Mohile SG, Sun V, et al. Barriers to clinical trial enrollment of older 10.1093/jncimonographs/lgac019. adults with cancer: a qualitative study of the perceptions of community and 8. Hurria A, Levit LA, Dale W, et al.; for the American Society of Clinical academic oncologists. J Geriatr Oncol. 2020;11(2):327-334. Oncology. Improving the evidence base for treating older adults with cancer: 6. Hurria A, Dale W, Mooney M, et al.; for the Cancer and Aging Research American Society of Clinical Oncology Statement. J Clin Oncol. 2015;33(32): Group. Designing therapeutic clinical trials for older and frail adults with 3826-3833.

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JNCI Monographs – Oxford University Press

Published: Dec 15, 2022

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