A digital health intervention to enhance well-being among adolescent and young adult survivors of cancer: Results from the EMPOWER full factorial trial.

12006 Background: Adolescent and young adult (AYA) survivors of cancer are at significant risk of adverse psychological outcomes, yet scalable, efficacious interventions to address their needs are limited. We evaluated a self-guided digital health intervention with affective, behavioral, and cognitive skills, “Enhancing Management of Psychological Outcomes With Emotion Regulation” (EMPOWER), for improving psychological outcomes. Methods: We recruited AYAs ( n = 352; 74% female, median age 33 years) from three comprehensive cancer centers between Dec 2021 and Sept 2024. AYAs were diagnosed at and currently aged 15 to 39 years, within 5 years post-curative treatment, and had internet access. In a full factorial design, AYAs were randomly assigned to 5 weekly components, either EMPOWER intervention or attention control (2 5 = 32 arms): 1. positive events, capitalizing & gratitude (vs. cognitive skills); 2. mindfulness (vs. financial literacy); 3. positive reappraisal (vs. nutrition); 4. personal strengths & goal-setting (vs. weight management); 5. acts of kindness (vs. sun protection). Didactic lessons and skills practices were delivered via a website designed specifically for the study. AYAs completed PROMIS measures for positive affect (primary outcome), and depression and anxiety (secondary outcomes) at pre-intervention, post-intervention, and two and four months post-intervention. Using the intent-to-treat principle and a mixed model with linear contrasts, we estimated average within-person changes over time by component (intervention/control) for AYAs and compared changes by component. Results: From pre to post-intervention, positive affect increased (p<0.05) among those in 3 of the 5 EMPOWER and 4 of the 5 control components (mean change = 1.4 to 1.9) and anxiety decreased (p<0.05) for those in 4 of 5 EMPOWER and 4 of 5 control components (mean change = -1.2 to -2.0). Further, anxiety was significantly lower (p<0.05) for all EMPOWER and control components at two and four-months post intervention (mean change = -1.3 to -2.4). There was little change in depression for any group. We found no treatment effects for any outcome whereby AYAs who received intervention content had significantly greater improvements than those receiving attention control content. Instead, some EMPOWER (positive events, capitalizing, & gratitude; acts of kindness) and control components (nutrition) were associated with clinically meaningful changes in outcomes, based on PROMIS metrics. Conclusions: Our findings suggest a range of affective, behavioral, and cognitive strategies drawn from both positive psychology and health education domains are similarly effective in enhancing positive affect and mitigating post-treatment anxiety and highlight the potential benefit of low-touch, self-guided digital health strategies for AYA survivors of cancer. Clinical trial information: NCT04317417 .