Becoming an “AYA Champion” to Increase AYA Enrollment on Clinical Trials

September 2019 Vol 10, No 9


Clinical Trials

Adolescent and young adult (AYA) patients aged 15 to 39 years are significantly underrepresented in cancer clinical trials. Underenrollment of AYAs limits the ability of researchers to determine the most effective treatments and improve survival and health-related quality of life in this population. Despite the recognition that disparities in AYA enrollment have existed for more than 2 decades, enrollment in this age group remains limited. But according to Michael Roth, MD, Director of the Childhood Cancer Survivorship Program and Co-Director of the Adolescent and Young Adult Oncology Program at MD Anderson Cancer Center, oncology navigators are well positioned to enhance this population’s access to clinical trials.

“The challenge is that cancer in AYAs is rare, and that’s a good thing; about 75,000 patients aged 15 to 39 are diagnosed with cancer in the US each year,” he said at the AONN+ 2019 Midyear Conference. “But because there are so few AYAs diagnosed with cancer, it’s very difficult to conduct clinical trials. This delays progress and delays our ability to understand what are the best options for these patients.”

Close collaboration between all stakeholders—medical oncology, pediatric oncology, research associates, navigators, and administrators—will be essential to increase AYA enrollment on these trials, he said.

Common Barriers to Enrollment

Although survival in many AYA cancers is improving, 5-year survival rates remain stagnant in malignancies such as acute lymphoblastic leukemia. Clinical trials provide the best setting in which to determine optimal treatment for these patients, but the problem is 2-fold: not only is there a lack of patient awareness of clinical trials, there is also a lack of provider awareness of eligible AYA patients. This is compounded by a lack of prioritization of these trials in general.

Additionally, AYAs are less likely to receive treatment at National Cancer Institute (NCI)-designated cancer centers, and community sites have limited access to research resources and clinical trials.

But collective efforts are being made to lessen disparities and increase AYA enrollment on trials. The Children’s Oncology Group Adolescent and Young Adult Responsible Investigator Network, launched in early 2018, is optimizing enrollment through a network of “AYA Champions.” Through collaboration with medical oncology and support from hospital leadership, these “Champions” utilize shared resources and approaches to enhance local enrollment. Another NCI Community Oncology Research Program is using a 2-step intervention plan to improve AYA enrollment onto trials at their own sites.

The Path Forward

According to Dr Roth, although navigators are still fairly new in the realm of AYA oncology, they can play a vital role in connecting trials to patients, patients to trials, hospitals to trials, and institutions to networks and resources.

“You are on the frontline of clinical trial enrollment. You know who your patients are, and you connect with them,” he said. “We’re lacking that connection for our AYAs in clinical trials.”

As it currently operates, the path to AYA trial enrollment is very linear. It starts with a diagnosis of cancer and is followed by a series of questions to determine a patient’s eligibility for enrollment on a trial (ie, Does a clinical trial exist? Is the clinical trial accessible? Was the clinical trial presented to the patient?) If the answer to any of these questions is “no,” the AYA is typically never enrolled.

But according to Dr Roth, the necessary framework to tackle these issues would provide alternative courses of action when these roadblocks arise. For example, if the clinical trial is not accessible, provide a referral to an AYA center. If the clinical trial was not presented, educate physicians on the importance of enrollment, and encourage crosstalk between pediatricians and medical oncology. He said this requires work at the local level, and developing AYA “Champion” Networks, involving stakeholders across the country and at every site, will be integral to making this happen.

Despite the paucity of studies assessing navigators’ views on barriers and facilitators to AYA enrollment on clinical trials, navigators are well positioned to provide valuable insight and are likely to have ideas on novel and realistic approaches, said Dr Roth. He encouraged those interested in collaboration to reach out to him at This email address is being protected from spambots. You need JavaScript enabled to view it..

“If we’re looking to develop strong interventions to tackle AYA enrollment strategies,” he added, “we need partners like you.”

Related Articles
Cancer Clinical Trials: The Navigator’s Role in Ensuring Inclusivity
AONN+ 2020 Conference Highlights Special Feature
Underrepresented in cancer clinical trials, racial and ethnic minorities often miss out on the benefits of research participation. Educating potential participants on clinical trials can increase enrollment among populations that have been commonly overlooked.
Navigation’s Impact on Clinical Trial Participation in Cancer Research: Barriers, Evidence, and Strategies
Claire White, BSN, RN, CPHON, Laura Hynes, MA, BSN, RN, Lucy J. Gansauer, MSN, RN, OCN, CCRP, Mary Van Cleave, BSN, RN, OCN, Lavinia Dobrea, RN, MS, OCN, Amy Meleason, BSN, RN, OCN, Daniel McGough, BS, CCRP
August 2019 Vol 10, No 8
What you need to know about discussing clinical trials with your patients.
Darolutamide, a Novel Androgen Receptor Inhibitor, Extends Metastasis-Free Survival in Patients with High-Risk Prostate Cancer
May 2019 Vol 10, No 5
Darolutamide, an investigational androgen receptor inhibitor, significantly improved metastasis-free survival in men with high-risk nonmetastatic castration-resistant prostate cancer (CRPC) compared with placebo in a large phase 3 clinical trial.
Last modified: May 7, 2021

Subscribe to the Journal of Oncology Navigation & Survivorship®

To sign up for our print publication or e-newsletter, please enter your contact information below.

  • First Name *
    Last Name *
    Profession or Role
    Primary Specialty or Disease State
  • Please enter your mailing address.

    Address Line 2
    Zip Code