Clinical Trial Decision Aid (DECIDES) for Adolescents and Young Adults with Cancer and their Caregivers

Children’s Hospital of Philadelphia, Philadelphia, PA

Adolescents and young adults (AYA) with cancer have lower rates of participation in therapeutic clinical trials; they have limited involvement in decision-making, do not fully understand clinical trials, and are vulnerable to acute distress undermining their decision processes. We developed a decision support tool (DECIDES = AYA Deciding about Enrolling on a Clinical Intervention Trial: Decision Aid for Education and Support) to increase collaboration among AYA, primary caregivers, and providers in clinical trial decision-making. DECIDES is based on decision theory, findings from our qualitative studies of AYA decision-making, evidence-based decision tools in adult oncology, and feedback from CHOP AYA Patient Steering Committee, caregivers, and Scientific Advisory Committee. Content/format includes information on cancer clinical trials and a value clarification exercise in a web-based format with written information, games, video, and animation. We will use a hybrid design to pilot test and identify implementation strategies with newly diagnosed or relapsed AYA: DECIDES alone (n=20), DECIDES+coach (n=20), and Usual Care (n=10). Hypotheses: (1) DECIDES will be acceptable and feasible; (2) DECIDES groups will have more knowledge about cancer clinical trials, open clinical trial attitudes, positive decision processes, and collaborative decision-making than the usual care group. Interviews with participants will provide feedback on DECIDES for future, larger scale implementation.