Grant Number:	1K99CA267481-01 Interpret this number
Primary Investigator:	Fladeboe, Kaitlyn
Organization:	Seattle Children'S Hospital
Project Title:	Addressing Social Needs of Adolescents and Young Adults (AYAS) with Cancer
Fiscal Year:	2022

PROJECT SUMMARY Adolescents and young adults (AYAs) with cancer are at high risk for poor psychosocial and quality of life outcomes. One way cancer may confer risk is through compromising social support, a robust predictor of psychosocial wellbeing. AYAs highly value support from family, friends, and other AYA patients. However, many AYAs with cancer feel isolated and report that their relationships are strained during their treatment, resulting in long term social support deficiencies. Despite established demand, few programs targeting AYA social support needs exist. Those that do lack theoretical bases or developmental tailoring. The current study uses a novel approach to address these needs by adapting an evidence-based, multicomponent supportive care program to target social relationship coping efficacy (SRCE). Defined as one’s perceived ability to maintain or enhance close relationships in the context of illness, SRCE is a new construct with a strong theoretical basis that is well aligned with AYAs’ developmental needs. Bolstering SRCE will enable AYAs to manage cancer-related relational challenges and seek and maintain supportive relationships, thereby buffering the negative impact of cancer on perceived support. Moreover, targeting SRCE within the Promoting Resilience in Stress Management (PRISM) program, a skill based AYA resilience intervention with a history of successful adaptation, will enable the success of this work and potential for later dissemination. Building on preliminary data and following the Obesity-Related Behavioral Intervention Trials (ORBIT) model for behavioral intervention development, the first phase of this study (K99, 2 years) aims to refine the PRISM+SRCE adaptation. Specifically, the goals of this phase are to (1) iteratively refine SRCE component content using AYA (n≥12) stakeholder feedback; (2) refine practical aspects of the combined PRISM+SRCE program including delivery, training, and fidelity monitoring using AYA (n=15) and PRISM interventionist (n=3) stakeholder feedback; and (3) develop a final intervention manual and delivery protocol. Additionally, K99 activities will provide applied opportunities to complement the learning goals of a promising early career behavioral scientist, including developing expertise in qualitative research methods and training in conceptual and practical aspects of clinical trial design and conduct. The second, independent phase of this study (R00, 3 years) aims to establish proof-of-concept of this adaptation. Through a two-site randomized- controlled trial of N=100 AYAs newly diagnosed with cancer, the goals of this phase are to (1) establish feasibility and acceptability of the PRISM+SRCE program; and, (2) explore whether PRISM+SRCE improves psychosocial outcomes compared to usual care. Findings from this study will critically inform a subsequent (R01-funded) Phase III efficacy trial of this adaptation. This project fulfills the objectives of RFA-CA-20-057 in the Cancer Control Science area by aiming to enhance an applied behavioral intervention to improve AYA quality of life. If successful, this adaptation will both improve AYA social outcomes and bolster the overall impact of the PRISM program, thus creating a promising paradigm for comprehensively addressing AYA psychosocial needs.

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