Scoping Review

Barriers and Facilitators to Enrollment in Pediatric Oncology Clinical Trials

Cherie L. Hauck, PhD, RN; Kathleen B. Cartmell, PhD; Martina Mueller, PhD, RN; Teresa J. Kelechi, PhD, RN

Disclosures

Pediatr Nurs. 2021;47(2):79-96. 

In This Article

Abstract and Introduction

Abstract

Cancer is the second-leading cause of death among children in the United States. Oncology clinical trials are designed to investigate new potential therapies. Approximately 60% of children with cancer are treated on clinical trials. The purpose of this scoping review of the literature is to explore what is known about barriers and facilitators to enrollment in pediatric oncology clinical trials. Arskey and O'Malley's (2005) methodological framework guided the scoping review. The electronic databases of PubMed and SCOPUS were searched for relevant publications. Thirty publications met eligibility criteria, which included empirical publications related to barriers and facilitators to enrollment in pediatric oncology clinical trials. Results and discussion of barriers and facilitators were organized by using a modified version of the Social Ecological Model (SEM). Trial-level barriers included lack of an available trial, trials closed to accrual, and eligibility criteria. Individual factors included age, sex, race/ethnicity, insurance status, cancer characteristics, and motivation. Interpersonal factors included parents' desire for continuity of care by health care providers, physicians' discussions with parents and children about clinical trials, and physicians' attitudes about clinical trials. Organizational factors that influenced enrollment included local availability of a clinical trial and continuity of care. No studies of community or policy-level barriers and facilitators were found. Theoretically based studies need to be conducted to identify factors at SEM levels not previously studied and investigate interventions to address factors that adversely affect enrollment. Furthermore, interdisciplinary collaboration among nurses and other professionals working at each SEM level is vital to surmount enrollment obstacles.

Introduction

Surpassed only by injury, cancer is the second-leading cause of death among children in the United States (American Cancer Society [ACS], 2021). In 2021, 10,500 children under 15 years old are predicted to be newly diagnosed with cancer, and of these, 1,190 are expected to die (ACS, 2021). As evidenced by these statistics, new effective oncological therapies are needed for children. Oncology clinical trials are designed to discover safe and efficacious means to prevent, diagnose, and treat cancer and manage its symptoms (National Cancer Institute [NCI], 2020). Clinical trials are responsible for the childhood cancer cure rate increasing from less than 10% to over 80% during the past 40 years (Children's Oncology Group [COG], n.d.a). There are over 1,900 active oncology clinical trials for patients aged 1 to 17 years in the ClinicalTrials.gov database (U.S. National Library of Medicine, 2020).

Enrollment is significant because it is a key metric in determining the success of a clinical trial because optimal sample size is required for valid results (Melnyk & Morrison-Beedy, 2012). In addition, if a clinical trial is extended due to poor enrollment, its costs continue to rise, resulting in budget deficits and wasted resources (Steinman et al., 2017). However, enrollment of participants in oncology clinical trials is a challenge. Approximately 60% of children with cancer are treated on clinical trials (COG, n.d.b). Existing literature about barriers and facilitators to enrollment in pediatric oncology clinical trials is limited. Identifying factors inhibiting enrollment is imperative so that interventions addressing enrollment challenges be developed, implemented, and evaluated to foster the successful completion of oncology clinical trials. Thus, the purpose of this scoping review of the literature was to explore what is known about barriers and facilitators to enrollment in oncology clinical trials for children. The research question driving this review is "What are the barriers and facilitators to enrollment in oncology clinical trials for children?"

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