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A Pilot RCT of the PRISM Intervention for AYAs With Cancer

Seattle Children's Hospital · 2015
ClinicalTrials.gov · Datasets · License: Public Domain · 2015
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acute-lymphoblastic-leukemiacancerlymphomasarcoma
Study Title: A Pilot Randomized Controlled Trial of the Promoting Resilience in Stress Management (PRISM) Intervention for Adolescents and Young Adults with Cancer Study Population and Sample Size: Two cohorts of Adolescent and Young Adult (AYA) patients with diagnosis of new or recurrent cancer between 1 and 10 weeks prior to enrollment: those ages 13-17 (N=50); (2) those ages 18-25 (N=50). Study Design: Pilot randomized controlled trial (RCT). Primary Objective: To test the efficacy of the "Promoting Resilience in Stress Management" (PRISM) among Adolescents and Young Adults with cancer. Primary Outcome: Change in patient-reported resilience (based on score of standardized Connor-Davidson Resilience Scale) at 6 months. Secondary Outcomes: 1. Patient-reported resilience at 2, 4, and 12 months 2. Patient-reported self-efficacy, benefit-finding, psychological distress, quality of life, and health-behaviors at 6 and 12 months. 3. Qualitative assessment of patient-reported goals at 6 and 12 months 4. Development of a cohort of AYA cancer survivors for assessment of long-term psychosocial outcomes Study Duration: 3 years
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