Clinical trial enrollment of adolescent and young adult patients with cancer: a systematic review of the literature and proposed solutions

Abstract

Abstract:Although there has been significant progress in the survival of children and older adults with cancer in the last few decades, this has not been the case for adolescent and young adults (AYAs). Although there are multiple reasons why outcomes for AYAs have not improved over time, it is evident from studies that AYAs fare better when enrolled in clinical trials, yet they are much less likely to participate in trials when compared with children and older adults. The goal of this review is to understand the trends in clinical trial enrollment of AYA patients over time, recognize facilitators and barriers to enrollment, and evaluate methods that have been utilized in order to improve clinical trial enrollment for this group of patients. A systematic review of the literature was performed to search for articles related to AYA oncology and clinical trials. The articles that met all inclusion criteria were then subject to full-text review, which yielded 17 articles that used quantitative, qualitative, or mixed methods. The articles reviewed demonstrated that for AYA patients, survival and clinical trial enrollment have shown some improvement over time, yet participation in clinical trials is still relatively poor, particularly for older patients within this group. Major barriers to enrollment in clinical trials include limited access and availability of trials, as well as patient knowledge. We have introduced the 4 Ps Conceptual "Onion Skin" Model, which includes patient, partners, providers, and policies, with the goal of reducing barriers to trial enrollment. Interventions utilizing this model include the establishment of more AYA centers, increased collaboration among cooperative groups with the goal of creating more AYA-specific trials, and educating patients and providers about the benefits of participating in clinical trials. Further studies are needed to understand which interventions would be most successful in encouraging AYA patients to enroll in clinical trials.

Systematic review of barriers and facilitators to clinical trial enrollment among adolescents and young adults with cancer: Identifying opportunities for intervention

“…CCTs are an essential component for studying disease biology and improving survival and health‐related quality‐of‐life outcomes; however, only 3% to 14% of all AYAs with cancer enroll in a CCT . Previous reviews on this topic have identified patient‐level barriers to CCT enrollment, including concerns about treatment side effects and a lack of patient awareness . Our review has extended this body of literature to encompass site‐level barriers that may arise before the patient is ever presented with a CCT (eg, physician preference to present the trial) .…”

“…7,8,10,32 Previous reviews on this topic have identified patient-level barriers to CCT enrollment, including concerns about treatment side effects and a lack of patient awareness. 13,14 Our review has extended this body of literature to encompass sitelevel barriers that may arise before the patient is ever presented with a CCT (eg, physician preference to present the trial). 21 Despite a growing focus on AYA patients with cancer and disparities in care and outcomes, few studies have adequately addressed factors contributing to the low enrollment of AYAs into CCTs, and even fewer studies have assessed the efficacy of interventions enhancing AYA enrollment.…”

“…Suggested barriers include treatment institutions, a lack of available trials for cancer types or certain age groups (older AYAs), and insurance status . Two previous reviews have examined barriers and/or facilitators to CCT enrollment in AYA patients . The first review examined trends in CCT enrollment among AYAs across time and included a brief overview of facilitators and barriers to CCT enrollment in AYAs .…”

“…13,14 The first review examined trends in CCT enrollment among AYAs across time and included a brief overview of facilitators and barriers to CCT enrollment in AYAs. 14 That review was conducted in May 2015 and did not include keywords for "facilitator" or "barrier" in the literature search. Therefore, an updated and more comprehensive review of the barriers and facilitators to CCT enrollment is warranted.…”

The challenges of making informed decisions about treatment and trial participation following a cancer diagnosis: a qualitative study involving adolescents and young adults with cancer and their caregivers

“…AYA with cancer have lower improvements in survival rates than children and older adults and their low participation in cancer trials is believed to be a contributory factor [15][16][17]. This has prompted calls to identify and address barriers to trial enrolment in this age group [7,11].…”