Approximately 21,400 adolescents and young adults (AYA) ages 15 to 29 years were diagnosed with cancer in 2000, which is nearly 3 times that of patients diagnosed in the first 15 years of life. Contrary to younger and older age groups, the 5-year survival and mortality reduction rates for these AYA with cancer have remained stagnant, particularly for AYA who are from ethnic minority groups. One reason for these disparities is that fewer AYA with cancer participate in therapeutic or Phase III clinical trials. Lack of participation in clinical trials both reduces access to direct medical benefits and hinders advances for others who seek AYA cancer treatment.
We conducted qualitative interviews with families of AYA with cancer and healthcare providers and discovered that AYA are not involved in decision making about clinical trials enrollment despite provider and caregiver efforts to direct treatment information to the AYA. AYA describe the presentation of information as ineffective in promoting their understanding of treatment options, and providers feel challenged to maintain engagement of AYA in treatment planning at diagnosis. Thus, research on how to increase involvement of AYA in clinical trials decision making may be critical to addressing disparities in AYA cancer outcomes.
Using both qualitative and quantitative methods (mixed methods) and a randomized trial, our current research aims to develop and test a decision support intervention comprised of an innovative web-based decision aid (DECIDES = AYA Deciding about Enrolling on a Clinical Intervention Trial: Decision Aid for Education and Support). DECIDES aims to increase AYA involvement in clinical trials decision-making and improve decision processes for AYA and primary caregivers. DECIDES is informed by health behavior theory, prior research, stakeholder input to increase usability and respond to AYA preferences, and established decision aid development guidelines. Further, DECIDES is developmentally appropriate, considers demand literacy, and contains components that increase knowledge about cancer and clinical trials, addresses attitudes to Phase III clinical trials, and weighs clinical trials benefits and barriers relative to values for AYA and their primary caregivers. In addition, we are in the process of validating a measure of attitudes towards clinical trials enrollment for AYA and their parents.
This research is central to the goals established by the Children’s Oncology Group and National Cancer Institute to address the unique and unmet needs of AYA with cancer through increased research on availability of and enrollment on clinical trials. Data from this study will inform a larger multi-site randomized trial to establish the efficacy of DECIDES for this vulnerable subgroup of patients with cancer.