Optimization of a digital health intervention to enhance well-being among adolescent and young adult cancer survivors: Design and methods of the EMPOWER full factorial trial.

Adolescent and young adult cancer survivors (AYAs) experience clinically significant distress and have limited access to supportive care services. Interventions to enhance psychological well-being have improved positive affect and reduced depression in clinical and healthy populations and have not been routinely tested in AYA survivors. We are optimizing a web-based positive skills intervention for AYA cancer survivors called Enhancing Management of Psychological Outcomes With Emotion Regulation (EMPOWER) by: (1) determining which intervention components have the strongest effects on well-being and (2) identifying demographic and individual difference variables that mediate and moderate EMPOWER's efficacy. EMPOWER is a five-session online intervention that teaches behavioral and cognitive skills for increasing psychological well-being. Guided by the Multiphase Optimization Strategy (MOST), we assign two levels (yes, no) to each of five intervention components (positive events, capitalizing, & gratitude; mindfulness; positive reappraisal; personal strengths & goal-setting; acts of kindness), allowing us to evaluate the effects of individual and combined intervention components on positive affect in a full factorial design. Post-treatment AYA cancer survivors (N = 352) are recruited from participating NCI-designated comprehensive cancer centers and randomized to one of 32 experimental conditions. Our primary outcome is positive affect; potential mediating and moderating variables include coping self-efficacy and emotional support, respectively. Upon trial completion, we will have an optimized, digital health intervention to enhance psychological well-being among AYA cancer survivors. EMPOWER will be scalable and primed for a large, multi-site trial among AYAs who would otherwise not have access to supportive care interventions to manage distress and enhance well-being.