The SCCIP-N Trial Protocol: A Randomized Controlled Trial of a Nurse-Led Family Intervention with Hybrid Psychosocial and Physiological Outcome Assessment in Pediatric Cancer

BackgroundPost-traumatic stress symptoms (PTSS) are prevalent among children with cancer and their families. Although family-based interventions such as the Surviving Cancer Competently Intervention Program (SCCIP) are effective, their reliance on mental health specialists limits scalability, highlighting the need for nurse-led approaches. Methods and analysisThis multicenter randomized controlled trial will enroll 110 families of children with cancer to evaluate the efficacy of a nurse-led adaptation, the SCCIP-N. Participants from Hunan and Xinjiang will be randomly assigned (1:1) to the intervention or an active control group. The study employs a hybrid outcome assessment strategy, integrating validated psychosocial measures with objective physiological monitoring. Assessments occur at baseline (T0), 1 week (T1), 4 weeks (T2), and 8 weeks (T3) post-intervention. The primary outcome is PTSS in children and caregivers. Secondary outcomes include posttraumatic growth, cognitions, anxiety, depression, family management, resilience, quality of life, and sleep quality. Objective physiological data (e.g., sleep, heart rate) from primary caregivers will be continuously collected using the Huawei Band 9. A process evaluation will follow the RE-AIM framework. Data will be analyzed according to intention-to-treat principles using linear mixed-effects models. DiscussionThis trial will evaluate the efficacy of a novel, nurse-led family intervention (SCCIP-N) for pediatric oncology families. By combining psychosocial and physiological assessment, it aims to provide a comprehensive, multidimensional evaluation of intervention effects. If effective, SCCIP-N could be integrated into routine care to improve family psychological outcomes and inform future implementation strategies. Trial registrationChiCTR, ChiCTR2500114338. Registered on Dec 10, 2025.