Multicentre randomised controlled trial of a nurse-led family intervention on post-traumatic stress symptoms in families of children with cancer in China: protocol for the SCCIP-N trial.
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BACKGROUND: Post-traumatic stress symptoms (PTSS) are prevalent among children with cancer and their families. Although family-based interventions such as the Surviving Cancer Competently Intervention Programme (SCCIP) are effective, their reliance on mental health specialists limits scalability, highlighting the need for nurse-led approaches. This trial aims to evaluate the efficacy of SCCIP-N, a nurse-led family-based psychosocial intervention, in reducing PTSS among families of paediatric cancer patients in China. METHODS AND ANALYSIS: This multicentre randomised controlled trial will enrol 110 families across Hunan and Xinjiang. Participants will be randomly assigned (1:1) to the intervention group or an active control group, stratifying randomisation by study site. The study employs a hybrid outcome assessment strategy that integrates validated psychosocial measures with objective physiological monitoring. Assessments occur at baseline (T0), 1 week (T1), 4 weeks (T2) and 8 weeks (T3) postintervention. The primary outcome is PTSS in children and caregivers. Secondary outcomes include post-traumatic growth, post-traumatic cognitions, anxiety, depression, family management, family hardiness, quality of life, sleep quality and objective physiological measures collected from primary caregivers. Wearable devices will continuously record these physiological measures, including total sleep time, sleep score, heart rate and resting heart rate. A process evaluation will apply the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Data will be analysed according to intention-to-treat principles using linear mixed-effects models. Recruitment of participants began on 20 December 2025, and the study is expected to be completed by 20 December 2026. ETHICS AND DISSEMINATION: The study was approved by the Ethics Review Committee of Xiangya School of Nursing, Central South University (approval number: E2025172) and the Medical Ethics Committee of Central South University (approval number: CSUMEC-E2025011). Written informed consent will be obtained from all participants. Findings will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: ChiCTR2500114338.