A prospective comparison of cancer clinical trial availability and enrollment among adolescents/young adults treated at an adult cancer hospital or affiliated children’s hospital

Abstract

Background: Low cancer clinical trial (CCT) enrollment may contribute to survival disparities affecting adolescents and young adults (AYAs, 15–39 years). This study evaluated whether differences in CCT availability related to treatment site could explain this low CCT enrollment. Methods: This prospective, observational cohort study was conducted at an academic children’s hospital and its affiliated but geographically separated adult cancer hospital within a National Cancer Institute-designated comprehensive cancer center. For consecutive, newly-diagnosed AYA patients, it was determined whether an appropriate CCT existed nationally, was available at the treatment site, and was utilized for enrollment. Proportions of AYAs in these categories were compared between sites using the χ2test. Results: One hundred fifty-two consecutive AYA patients were included from the children’s hospital (n=68, aged 15–20 years) and adult cancer hospital (n=84, aged 18–39 years). Although there was no difference in CCT existence for individual AYA patients by site (children’s hospital 36/68 [52.9%] versus adult cancer hospital 45/84 [53.6%], p=0.938), CCT availability was significantly lower at the adult cancer hospital (14/84 [16.7%] versus 30/68 [44.1%], p<0.001). The proportion of AYAs enrolled was low at both sites (8/68 [11.8%] versus 6/84 [7.1%], p=0.327). Fewer existing CCTs were available at the adult cancer hospital (4/27 [14.8%] versus 8/14 [57.1%], respectively), and those were directed toward solid tumors and new agents. Conclusions: Efforts to improve low CCT enrollment among AYAs should be differentiated by treatment site. In the adult setting, these should be aimed at improving CCT availability by overcoming site-level barriers to opening existing CCTs.

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

“…However, 2 articles found that the proportions of AYAs and children treated at a children's hospital with an existing CCT were similar (48.3% of AYAs vs 53.8% of children) . In addition, the existence of a CCT for AYA patients was similar between a children's hospital (52.9%) and its affiliated adult institution (53.6%) …”

“…Six of the 13 AYA CCT studies addressed the accessibility of clinical trials and found that institution‐ or system‐level barriers to CCT enrollment made it difficult for AYAs to access trials . In one study comparing AYA CCTs at a children's hospital and its affiliated adult hospital, only 4.1% of AYAs treated at the adult institution enrolled in a CCT, whereas 26.4% did at the children's hospital .…”

“…In addition, AYAs treated at the adult institution for “AYA” cancers (eg, Hodgkin lymphoma) were not enrolled in any CCTs, but 27.3% of AYAs treated for the same disease at the children's hospital were enrolled in a CCT . Thomas and colleagues found that although AYAs treated at a children's institution and the affiliated adult hospital had similar proportions of existing trials, a significantly lower proportion of AYAs treated at the adult hospital had the existing trials activated at their treating institution (16.7%) in comparison with AYAs treated at the children's hospital (44.1%). In contrast, when AYAs and children (≤14 years old) were both treated at a children's hospital, the accessibility of CCTs was similar (39.7% of AYAs vs 47.5% of children) .…”

“…19 In addition, the existence of a CCT for AYA patients was similar between a children's hospital (52.9%) and its affiliated adult institution (53.6%). 20…”

“…Six of the 13 AYA CCT studies addressed the accessibility of clinical trials and found that institution-or system-level barriers to CCT enrollment made it difficult for AYAs to access trials. 8,[18][19][20][21][22] In one study comparing AYA CCTs at a children's hospital and its affiliated adult hospital, only 4.1% of AYAs treated at the adult institution enrolled in a CCT, whereas 26.4% did at the children's hospital. 21 In addition, AYAs treated at the adult institution for "AYA" cancers (eg, Hodgkin lymphoma) were not enrolled in any CCTs, but 27.3% of AYAs treated for the same disease at the children's hospital were enrolled in a CCT.…”