Feasibility and proof-of-concept of a combined resilience and social connection intervention for adolescents and young adults with cancer: a pilot randomized trial protocol.
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BACKGROUND: Adolescents and young adults (AYAs) with cancer experience deficits in social connection that persist into survivorship; currently, few interventions target this unmet need. The current article describes the protocol for a pilot, parallel-group randomized controlled trial of a psychosocial intervention [Promoting Resilience in Stress Management (PRISM)] that includes a new skill-based module targeting AYA social needs (SN). The aims are to (1) establish the feasibility and acceptability of the PRISM-SN-adapted program; and (2) demonstrate proof-of-concept via clinically meaningful improvements in patient-reported outcomes (PROs). METHODS: We anticipate 70 AYAs will enroll and complete data collection at two sites: Seattle Children's Hospital and UPMC Children's Hospital of Pittsburgh. Eligible AYAs are ages 12-25 years old; diagnosed with a new malignancy < 6 months; treatment plan includes chemotherapy and/or radiation; and are English-speaking. Enrolled AYAs are randomized 1:1 to receive PRISM-SN or usual care and complete surveys at baseline and 12-week follow-up. PRISM-SN includes 5 sessions (4 standard PRISM modules + new SN module) teaching behavioral skills associated with psychosocial wellbeing. Sessions are delivered 1:1 by a trained coach, in person or virtually, 1-2 weeks apart. Feasibility will be defined based on uptake, retention, and patient-reported intervention acceptability. Proof-of-concept will be defined based on clinically meaningful change and detectable differences in PROs at 12 weeks, including social relationship coping efficacy (primary PRO of interest), social support, quality of life, resilience, anxiety, depression, and hope. Descriptive statistics and covariate-adjusted regression models will be used to assess feasibility outcomes and examine trends and between-group differences in PROs across study arms. DISCUSSION: This pilot trial will determine feasibility of PRISM-SN in the context of a multi-site trial; provide proof-of-concept via effects of PRISM-SN on social connection outcomes; and represent an important step toward addressing an unmet need in AYA cancer care. Future directions include testing efficacy and effectiveness via larger multicenter trials. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT06242964.