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Although recent studies have shown increases in trial participation overall, there is still ample room for improvement.5,12 As shown in Figure 2, even in the latest studies, most young adults are not being enrolled in clinical trials. Clearly, common cancer types in AYAs such as lymphoma are well represented in clinical trials.2,5 However, even relatively frequent diagnoses such as germ cell tumors, which represent ~15%–25% of invasive cancers in AYAs, continue to harbor low clinical trial accrual, as in one study only 0.3% of patients with germ cell tumors were enrolled in clinical trials.5Unfortunately, while newer studies of patients with pediatric germ cell tumor have suggested that dose intensity may improve survival for high-risk patients, it is not known whether this benefit would also translate to AYA patients as similar trials have not been open to this group.31 This suggests the need for more AYA-specific trials that can better evaluate treatments for the common diagnoses that affect this population.
Throughout the AYA oncology literature is the corollary that treatment protocols should be more specific to tumor biology rather than age. In fact, some authors have argued that age should not be considered as a factor in defining treatment and that patients should be treated according to tumor type.27 Indeed, in the UK, two trials for bone sarcomas, EURAMOS-1 and EURO EWINGS-99, have opened the age eligibility to 0–40 years and 0–50 years, respectively.7 This led to significant increases in clinical trial enrollment rates across all AYA age groups in 2005–2008 when compared with data from 1997 to 2002, in the UK.7 Next-generation sequencing is starting to become a very useful tool, allowing providers to understand variations in cancer biology, which may affect individual treatment plans including whether a patient should be treated according to a pediatric or adult protocol.28,29 While widening age eligibility criteria can help increase clinical trial enrollments for AYAs, attention to adverse outcomes, especially among pediatric patients, will undoubtedly be important to monitor the benefits and pitfalls as more patients participate in clinical trials over time.
Some of the difficulty of enrolling AYA patients on clinical trials is the informed consent process. Specifically for adolescents, providers must deal with patients of varying maturity and ultimately, only parents have the power to consent. This leads to many providers focusing their discussions on the parents, yet studies have shown that patients appreciated when they were given the facts directly and the opportunity to make decisions.32 Of course success in understanding the information related to a clinical trial is not only delivering the facts but also how those facts are delivered. Studies have shown that patients would prefer that the information could be individualized and given in different formats, such as an audio or video platform.33 Strategies such as these are likely to lead to better understanding and therefore, more willingness to participate in a clinical trial.
Besides a lack of understanding, some patients may mistrust the clinical trials system and its process. The AYA HOPE Study revealed the most common reason that AYAs did not participate in clinical trials was the fear that the medications that would be given to them were not sufficiently tested.13Certainly, explaining what is known about the medication being studied including potential side effects may help alleviate these fears and lead to improved enrollment. More importantly, providers should demystify the concept of clinical trials with patients, and convey that these trials are our “gold standard” of research in medicine. This may be best accomplished through community-based participatory research, which involves the mutual transfer of knowledge and power sharing in decision making among community and academic partners.34 Providers could partner with groups such as Stupid Cancer, an organization that provides patient education and advocates for AYAs, and may be effective in informing AYA patients of the potential benefits of participating in clinical trials.
In addition to educating patients, primary care providers must also be educated about the advantages of enrolling patients on clinical trials in order to improve referral patterns. Although multiple studies have shown that a majority of AYA patients are referred to oncologists in the community, Wolfson et al showed that simply by receiving care at an NCI-designated cancer center, outcomes were improved for AYA patients with WHO grade II central nervous system tumors. Furthermore, patients aged 22–39 years were less likely to receive treatment at an NCI-designated cancer center due to insurance, low socioeconomic status, and distance >5 miles.35 Regarding insurance, the recent passing of the Affordable Care Act has allowed more AYAs to obtain health insurance and should translate into an increase in referrals to NCI-designated cancer centers.37 Still, more can be done to overcome these practical barriers.
There are limited studies examining interventions used to recruit AYA patients to enroll in clinical trials. Some data exist for racial minorities, given that many studies have shown decreased participation in clinical trials compared with Caucasians.37 One such example demonstrated increased accrual for Hispanic women by utilizing a media campaign when compared with a clinic registry.38Given the different ways that AYAs communicate and interact with each other in contrast to older adults, it is likely that a similar campaign utilizing the Internet with delivery over multiple platforms may prove helpful. Many have had success with online surveys for the AYA population and acknowledge that the Internet is a useful tool to encourage AYAs to participate in clinical research.39Another example showed that African Americans had increased accrual on clinical trials with the addition of a church-based project.40 A similar trend was seen in a study of adolescents with chronic diseases, demonstrating that they are more likely to be compliant with treatment if they have good support from family, friends, and nurses.41 As this relates to AYAs, this suggests that receiving information within a trusting and supportive environment may lead to increased participation in clinical trials.
The psychosocial challenges of this population and the success of Shaw’s program at Pittsburgh demonstrate that increasing the number of AYA centers will likely help with the enrollment of patients on clinical trials by improving availability, accessibility, and patient knowledge. Similar success has been seen in the UK, where the Teenage Cancer Trust has created several cancer units designed specifically for adolescents. They have also implemented “shared care” centers, which are hospitals with general pediatric services but also affiliated with cancer centers, and can provide many services to cancer patients. Teen Cancer America is now developing similar centers and programs in the United States. These centers allow patients to receive some of their care at institutions that are often closer to home.42 They also allow for collaboration between adult and pediatric providers, and will improve the availability of trials to this population. Furthermore, this environment is likely to make AYA patients feel more comfortable by providing them with an interdisciplinary team, which can better comprehend their needs, including their understanding of clinical trials.
