Low Enrollment of Adolescents and Young Adults Onto Cancer Trials: Insights From the Community Clinical Oncology Program

Purpose: Stagnant outcomes for adolescents and young adults (AYAs; 15 to 39 years old) with cancer are partly attributed to poor enrollment onto clinical trials. The National Cancer Institute (NCI) Community Clinical Oncology Program (CCOP) was developed to improve clinical trial participation in the community setting, where AYAs are most often treated. Further, many CCOP sites had pediatric and medical oncologists with collaborative potential for AYA recruitment and care. For these reasons, we hypothesized that CCOP sites enrolled proportionately more AYAs than non-CCOP sites onto Children’s Oncology Group (COG) trials. Methods: For the 10-year period 2004 through 2013, the NCI Division of Cancer Prevention database was queried to evaluate enrollments into relevant COG studies. The proportional enrollment of AYAs at CCOP and non-CCOP sites was compared and the change in AYA enrollment patterns assessed. All sites were COG member institutions. Results: Although CCOP sites enrolled a higher proportion of patients in cancer control studies than non-CCOP sites (3.5% v 1.8%; P < .001), they enrolled a lower proportion of AYAs (24.1% v 28.2%, respectively; P < .001). Proportional AYA enrollment at CCOP sites decreased during the intervals 2004 through 2008 and 2009 through 2013 (26.7% v 21.7%; P < .001). Conclusion: Despite oncology practice settings that might be expected to achieve otherwise, CCOP sites did not enroll a larger proportion of AYAs in clinical trials than traditional COG institutions. Our findings suggest that the CCOP (now the NCI Community Oncology Research Program) can be leveraged for developing targeted interventions for overcoming AYA enrollment barriers.

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A qualitative study of barriers and facilitators to enrollment of adolescents and young adults onto cancer clinical trials at NCI community oncology research program (NCORP) sites.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e19050 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e19050-e19050 ◽

Cited By ~ 1

Author(s):

Elizabeth Siembida ◽

Holli Ann Loomans-Kropp ◽

Irene Tami-Maury ◽

Lillian Sung ◽

Brad H. Pollock ◽

...

Keyword(s):

Clinical Trials ◽

Young Adults ◽

Qualitative Interviews ◽

Community Setting ◽

Barriers And Facilitators ◽

Adolescents And Young Adults ◽

Cancer Clinical Trials ◽

Stakeholder Views ◽

Oncology Research ◽

The Impact

e19050 Background: Cancer clinical trials (CCTs) contribute to improving patient survival and quality of life; however, adolescents and young adults (AYAs, 15-39 years old), are underrepresented in CCTs, especially in the community setting. We aimed to identify barriers and facilitators to AYA CCT enrollment in the NCORP. Methods: We conducted 43 one-on-one semi-structured qualitative interviews with key stakeholders involved in the enrollment of AYAs across a diverse group of NCORP primary (n = 5) and affiliate (n = 10) sites. Interviews were conducted remotely by 3 trained interviewers using the Zoom platform. Stakeholders were recruited from high and low AYA enrolling sites (AYA/total site enrollments > 10% and < 3%, respectively). Stakeholders were overall NCORP Site PIs (n = 5), lead NCORP administrators (n = 4), clinical research associates (n = 11), medical and pediatric oncologists involved in the enrollment of AYAs (n = 7), regulatory research associates (n = 5), nurse navigators (n = 6), and patient advocates (n = 5). Interviews were audiotaped and transcribed. Thematic analysis was conducted to identify themes and relate them back to our primary research questions regarding barriers and facilitators to AYA CCT enrollment. Results: Stakeholder views on enrollment barriers centered on 5 main themes: (1) lack of site-level prioritization or discussion of AYA enrollment; (2) limited number of clinical trials for AYAs available nationally, with few trials opened locally; (3) insufficient resources and research staff; (4) concerns about the cost effectiveness of opening AYA trials due to low numbers of eligible patients; and (5) patient misconceptions about CCTs. Stakeholder views on enrollment facilitators centered on 3 main themes: (1) presence of an AYA program focused on increasing enrollment; (2) having a designated site AYA “champion”; and (3) having site leadership identify AYA enrollment as a priority. Stakeholders agreed that incentivizing AYA enrollments via increased reimbursement and/or study credits could potentially lead to increased enrollment. Conclusions: In addition to identifying multiple shared barriers to AYA CCT enrollment, our study also identified possible interventions for enrollment improvement, including designation of AYA “champions”, increased reimbursement for AYA enrollments, and improving AYA’s understanding of CCTs. Further studies are needed to assess the impact of interventions aimed at increasing AYA enrollment across the NCORP.

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The NCI Community Oncology Research Program: What Every Clinician Needs to Know

American Society of Clinical Oncology Educational Book ◽

10.14694/edbook_am.2013.33.e84 ◽

2013 ◽

pp. e84-e89 ◽

Cited By ~ 3

Author(s):

Worta McCaskill-Stevens ◽

Alan P. Lyss ◽

Marge Good ◽

Thomas Marsland ◽

Rogerio Lilenbaum

Keyword(s):

Clinical Research ◽

Clinical Oncology ◽

Research Program ◽

Cancer Care ◽

Care Delivery ◽

Community Setting ◽

Cancer Control ◽

Community Clinical Oncology Program ◽

Oncology Research ◽

Community Oncology

Research in the community setting is essential for the translation of advances in cancer research into practice and improving cancer care for all populations. The National Cancer Institute is proposing a new community-based program, NCI Community Oncology Research Program (NCORP), which is the alignment of two existing programs, the Community Clinical Oncology Program, Minority-Based Community Clinical Oncology Program, and their Research Bases, and the National Cancer Institute's Community Cancer Centers Program. NCROP will support cancer control, prevention, treatment, and screening clinical trials and expand its research scope to include cancer care delivery research. Cancer disparities research will be integrated into studies across the continuum of NCORP research. Input from current NCI-funded community investigators provides critical insight into the challenges faced by oncology practices within various organizational structures. Furthermore, these investigators identify the resources, both administrative and clinical, that will be required in the community setting to support cancer care delivery research and to meet the requirements for a new generation of clinical research. The American Society for Clinical Oncology (ASCO) has initiated a forum to focus on the conduct of clinical research in the community setting. Resources are being developed to help practices in managing cancer care in community settings.

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Use of Communication Technology to Improve Clinical Trial Participation in Adolescents and Young Adults With Cancer: Consensus Statement From the Children's Oncology Group Adolescent and Young Adult Responsible Investigator Network

JCO Oncology Practice ◽

10.1200/op.21.00554 ◽

2021 ◽

Author(s):

Viswatej Avutu ◽

Varun Monga ◽

Nupur Mittal ◽

Aniket Saha ◽

Jeffrey R. Andolina ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Young Adults ◽

Consensus Statement ◽

Adolescents And Young Adults ◽

Trial Participation ◽

Cancer Clinical Trials ◽

Oncology Group ◽

Tumor Boards ◽

Remote Patient

Adolescents and young adults (AYAs; age 15-39 years) with cancer are under-represented in cancer clinical trials because of patient, provider, and institutional barriers. Health care technology is increasingly available to and highly used among AYAs and has the potential to improve cancer care delivery. The COVID-19 pandemic forced institutions to rapidly adopt novel approaches for enrollment and monitoring of patients on cancer clinical trials, many of which have the potential for improving AYA trial participation overall. This consensus statement from the Children's Oncology Group AYA Oncology Discipline Committee reviews opportunities to use technology to optimize AYA trial enrollment and study conduct, as well as considerations for widespread implementation of these practices. The use of remote patient eligibility screening, electronic informed consent, virtual tumor boards, remote study visits, and remote patient monitoring are recommended to increase AYA access to trials and decrease the burden of participation. Widespread adoption of these strategies will require new policies focusing on reimbursement for telehealth, license portability, facile communication between electronic health record systems and advanced safeguards to maintain patient privacy and security. Studies are needed to determine optimal approaches to further incorporate technology at every stage of the clinical trial process, from enrollment through study completion.

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Achieving high cancer control trial enrollment in the community setting: An analysis of the Community Clinical Oncology Program

Contemporary Clinical Trials ◽

10.1016/j.cct.2012.12.008 ◽

2013 ◽

Vol 34 (2) ◽

pp. 320-325 ◽

Cited By ~ 9

Author(s):

Sara R. Jacobs ◽

Bryan J. Weiner ◽

Lori M. Minasian ◽

Marjorie J. Good

Keyword(s):

Clinical Oncology ◽

Community Setting ◽

Cancer Control ◽

Community Clinical Oncology Program

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The Australian Youth Cancer Service: Developing and Monitoring the Activity of Nationally Coordinated Adolescent and Young Adult Cancer Care

Cancers ◽

10.3390/cancers13112675 ◽

2021 ◽

Vol 13 (11) ◽

pp. 2675

Author(s):

Pandora Patterson ◽

Kimberley R. Allison ◽

Helen Bibby ◽

Kate Thompson ◽

Jeremy Lewin ◽

...

Keyword(s):

Clinical Trial ◽

Young Adults ◽

Cancer Care ◽

Young Patients ◽

Adolescents And Young Adults ◽

Adolescent And Young Adult ◽

Trial Participation ◽

Clinical Trial Participation ◽

Activity Data ◽

Cancer Services

Adolescents and young adults (aged 15–25 years) diagnosed with cancer have unique medical and psychosocial experiences and care needs, distinct from those of paediatric and older adult patients. Since 2011, the Australian Youth Cancer Services have provided developmentally appropriate, multidisciplinary and comprehensive care to these young patients, facilitated by national service coordination and activity data collection and monitoring. This paper reports on how the Youth Cancer Services have conceptualised and delivered quality youth cancer care in four priority areas: clinical trial participation, oncofertility, psychosocial care and survivorship. National activity data collected by the Youth Cancer Services between 2016–17 and 2019–20 are used to illustrate how service monitoring processes have facilitated improvements in coordination and accountability across multiple indicators of quality youth cancer care, including clinical trial participation, access to fertility information and preservation, psychosocial screening and care and the transition from active treatment to survivorship. Accounts of both service delivery and monitoring and evaluation processes within the Australian Youth Cancer Services provide an exemplar of how coordinated initiatives may be employed to deliver, monitor and improve quality cancer care for adolescents and young adults.

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The challenges of clinical trials for adolescents and young adults with cancer

Pediatric Blood & Cancer ◽

10.1002/pbc.21459 ◽

2008 ◽

Vol 50 (S5) ◽

pp. 1101-1104 ◽

Cited By ~ 85

Author(s):

Andrea Ferrari ◽

Michael Montello ◽

Troy Budd ◽

Archie Bleyer

Keyword(s):

Clinical Trials ◽

Young Adults ◽

Adolescents And Young Adults

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The management of Hodgkin lymphoma in adolescents and young adults: burden of disease or burden of choice?

Blood ◽

10.1182/blood-2018-01-778548 ◽

2018 ◽

Vol 132 (4) ◽

pp. 376-384 ◽

Cited By ~ 11

Author(s):

Jamie E. Flerlage ◽

Monika L. Metzger ◽

Nickhill Bhakta

Keyword(s):

Overall Survival ◽

Clinical Trials ◽

Young Adults ◽

Hodgkin Lymphoma ◽

Burden Of Disease ◽

Health Care Services ◽

Survival Rates ◽

Adolescents And Young Adults ◽

Adult Health ◽

Treatment Regimens

Abstract Adolescents and young adults (AYAs) comprise the largest age group affected by Hodgkin lymphoma (HL). Despite excellent overall survival of AYA patients with HL due to advances in treatment regimens, therapy-associated late effects continue to be a concern in HL survivors, especially for younger patients who have decades of life remaining. Since the first clinical trial for HL with chemotherapy in 1964, subsequent protocols have attempted to reduce chemotherapy-induced toxicities and yet maintain high overall survival rates. Today, new analytic methods applied to data from survivorship cohorts, such as the recently described cumulative burden of disease metric, can be used to inform changes for future protocols. Although pediatric and adult trial consortia have followed this process, the AYA population, an age cohort split between pediatric and adult health care services, faces many barriers to care and is the least likely to be enrolled in clinical trials. AYA patients with HL theoretically have a choice to be treated in pediatric or adult protocols when presented with these options. Recent efforts by the National Clinical Trials Network, the Children’s Oncology Group, and others have been made to ensure that the burden of choice for the AYA population is not greater than the burden of disease.

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A qualitative study of barriers and facilitators to adolescents and young adults’ participation in cancer clinical trials: Oncologist and patient perspectives

Pediatric Blood & Cancer ◽

10.1002/pbc.29479 ◽

2021 ◽

Author(s):

Renata Abrahão ◽

Elysia M. Alvarez ◽

Austin R. Waters ◽

Crystal C. Romero ◽

Melissa M. Gosdin ◽

...

Keyword(s):

Clinical Trials ◽

Young Adults ◽

Qualitative Study ◽

Patient Perspectives ◽

Barriers And Facilitators ◽

Adolescents And Young Adults ◽

Cancer Clinical Trials

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Improving recruitment and retention of adolescents and young adults with cancer in randomized controlled clinical trials

International Journal of Adolescent Medicine and Health ◽

10.1515/ijamh-2018-0215 ◽

2019 ◽

Vol 0 (0) ◽

Author(s):

Sharron L. Docherty ◽

Stacey Crane ◽

Joan E. Haase ◽

Sheri L. Robb

Keyword(s):

Clinical Trials ◽

Young Adults ◽

Randomized Clinical Trials ◽

Adolescents And Young Adults ◽

Adolescent And Young Adult ◽

Recruitment And Retention ◽

Randomized Controlled Clinical Trials ◽

Pros And Cons ◽

Adult Resilience ◽

Psychosocial Programs

Abstract Participation of adolescents and young adults (AYAs) with cancer in randomized clinical trials (RCTs) is necessary to advance treatments and psychosocial programs. Exploring AYAs experiences in an RCT will inform strategies to support recruitment and retention. A qualitative design was used to study the experiences of 13 AYAs in the Stories and Music for Adolescent and Young Adult Resilience during Transplant I (SMART I) trial. Key themes included: Weighing the Pros and Cons; Randomization Preferences; Completing Measures; and Worthwhile Experience. The experiences of AYAs during RCTs can bring insights that inform the design and management of AYA trials. Strategies include improving assent/consent processes, design of electronic interfaces and encouraging researcher flexibility.

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