PROJECT SUMMARY/ABSTRACT The proposed adolescent and young adult (AYA) mixed methods project will meet the goals and scientific scope of the U01 by refining and testing a scalable intervention to mitigate and manage adverse long-term outcomes in AYA cancer survivors. By improving access to survivorship resources, health literacy, self-management skills and support, the intervention is designed to improve adherence to AYA healthcare guidelines and reduce cancer- related distress. The project leverages an existing survivorship informatics infrastructure, an established multicenter survivorship research network, and our experiences with a randomized controlled trial (RCT) with AYAs and a digital and telehealth program initially developed for hematopoietic cell transplant survivors. This research fills a critical gap in care for AYA survivors by providing a novel, personalized, technology-based self- management program with stepped care telehealth. To be scalable, it uses a risk-based delivery model targeted to AYA survivors with demonstrated need. The two-arm RCT will test the AYA-adapted INSPIRE digital program, including an interactive mobile app/website and social media, adding stepped care telehealth for those with continued distress, lack of survivorship healthcare literacy, or who are not using the digital program at 1 month. In the active control arm, survivors receive access to a study website with existing AYA survivor resource links followed by delayed access to the INSPIRE program. Specific aims are: 1) Among AYA survivors with elevated cancer-related distress, determine the efficacy of a self-management program, INSPIRE, delivered by interactive digital cross-device options and stepped care telehealth coaching, compared to the active control arm. 2) Among AYA survivors with inadequate adherence to healthcare guidelines, determine the efficacy of the INSPIRE digital and telehealth self-management program in improving overall healthcare adherence and cardiometabolic or subsequent malignancy surveillance compared to the active control arm. 3) Examine mechanisms associated with intervention efficacy including engagement with the online program, use of telehealth contacts, and improved health self-efficacy, health literacy, AYA-specific impact of cancer, and barriers to healthcare; and examine moderators of intervention engagement or response including cancer clinical factors, health status, and sociodemographic and environmental factors. 4) Define costs of maintaining and delivering components of the INSPIRE program if delivered in a scaled-up model of care. An exploratory aim will assess dissemination potential and define risk models associated with distress, poorer health status or healthcare nonadherence. Aims will be accomplished with a two-arm, multicenter, risk-stratified RCT of N=980 AYA survivors of leukemia, lymphoma, colorectal cancer, melanoma, or sarcoma, age 18-39, and 1-5 years post-diagnosis. The primary outcome is reduced distress at 3 months; secondary outcomes are improved adherence and reduced distress at 12 months. If effective, the program is positioned for accelerated dissemination/implementation to improve care for AYA survivors by using a scalable informatics-based administration and largely digital intervention program.

PROJECT NARRATIVE Adolescent and young adult (AYA) cancer survivors, live with emotional distress and health care demands that exceed those of their peers, but can have difficulty accessing the care they need. In a 5-site national study, this research will adapt a tested, personalized, interactive digital and telehealth survivorship program to the needs of AYA survivors. We will test the AYA-focused survivorship intervention in a randomized controlled trial to see if it improves emotional distress and adherence to health care guidelines after 3 and 12 months when compared to AYA survivors who receive access to a website of annotated links to existing survivorship resources followed by delayed access to the digital survivorship program after 12 months.