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.
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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.