||6U01CA246659-02 Interpret this number
||Fred Hutchinson Cancer Center
||An Interactive Survivorship Program to Improve Healthcare Resources [INSPIRE] for Adolescent and Young Adult (AYA) Cancer Survivors
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.
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