Evaluating and Implementing a decision support intervention (DECIDES) for adolescents and young adults newly diagnosed with cancer

/ABSTRACT Adolescents and young adults (AYA, 15-24 yo) are often sidelined in treatment-related decision-making (TRDM), compromising their emerging autonomy, identity, and relationships, as well as impacting self-management and cancer outcomes. Shared TRDM (i.e., AYA having a voice in their cancer care with their caregivers and oncology clinicians), begins with initial decisions at diagnosis (e.g., selecting a treatment, clinical trial enrollment) and evolves to ongoing decisions (e.g., treatment modifications, side effects management, supportive care interventions). TRDM occurs in a cancer communication ecosystem comprised of AYA access to unvetted online information, as well as caregiver and oncology clinician partners who often engage in TRDM on behalf of the AYA. Our and others’ research demonstrates the connection between involvement in shared TRDM and short- term (information needs, decision regret, participation in curative cancer clinical trials) and longer-term (self- management skills, medication adherence) outcomes for AYA impacted by cancer. We developed and conducted a pilot trial of one of the first decision support interventions for AYA, DECIDES (AYA Deciding about Cancer Clinical Intervention: Decision Aid for Education and Support), which is a theoretically-informed, scalable interactive web-based tool. We propose a randomized controlled trial (RCT) of the next iteration--DECIDES 2.0, which will be upgraded to an enhanced interactive mobile-friendly website with accompanying text messages, a Spanish language version, and will be delivered closer to diagnosis. The trial will occur at three pediatric cancer centers with 250 AYA (15-24 yo) enrolled within 4 weeks of diagnosis. Caregivers can also opt-in. Aim 1 will test the efficacy of DECIDES 2.0. We hypothesize that, compared to Usual Care, AYA randomized to DECIDES 2.0 will report greater involvement in shared TRDM at 8 weeks post-randomization (primary outcome) and 16 weeks, more positive decision-related processes (patient activation, fewer unmet information needs, less decision regret, more decision self-efficacy, increased preference for involvement), and better self-management (skills, allocation of responsibility, medication adherence) at 8 and 16 weeks. We will explore if patient activation and/or decision self-efficacy mediates or moderates the association of TRDM with self-management. To prepare for dissemination, Aim 2 will evaluate barriers and facilitators of implementation based on the Consolidated Framework for Implementation Research. Specifically, we will assess factors contributing to DECIDES 2.0 efficacy and identify how best to integrate it into practice via quantitative + qualitative evaluation of AYA, caregivers, and oncology clinicians’ perceived acceptability and implementation barriers and facilitators, and implementation feasibility and costs. Responsive to PAR-25-167, and led by a stellar multidisciplinary team, this proposal advances efforts to modify the cancer communication ecosystem and optimize cancer care for AYA by targeting their involvement in shared TRDM, ultimately optimizing medical and psychosocial outcomes. Results will inform a future implementation trial of DECIDES 2.0 across pediatric cancer programs. Project Number: 1R01CA309542-01A1 | Fiscal Year: 2026 | NIH Institute/Center: National Cancer Institute (NCI) | Principal Investigator: Lisa Schwartz (+1 co-PI) | Institution: CHILDREN'S HOSP OF PHILADELPHIA, PHILADELPHIA, PA | Award Amount: $749,133 | Activity Code: R01 | Study Section: Interdisciplinary Clinical Care in Specialty Care Settings Study Section[ICSC] View on NIH RePORTER: https://reporter.nih.gov/project-details/11450762