A complex family adaptation intervention for Chinese families of hospitalised children with newly diagnosed cancer: study protocol for a cluster randomized controlled trial design.

BACKGROUND: Paediatric cancer diagnoses significantly affect the psychosocial well-being of children and their families. Existing evidence shows that a multicomponent family intervention model is beneficial for improving the mental health and quality of life of families of children with cancer; however, these models have faced criticisms related to their cultural sensitivity and clinical applicability. To date, there is insufficient evidence on complex interventions and their application for families of hospitalised children with cancer in China. aiming to evaluate the effectiveness of a complex family adaptation intervention specifically designed for Chinese families of hospitalised children with newly diagnosed cancer.

METHODS: This study will develop a family adaptation complex intervention covered nine thematic contents and a three-day stress management program primarily consists of disease information support and common stress management techniques. Standardized scales will be used to collect self-reported data from parents and children, while generalised estimating equations, repeated measures analysis of variance, and regression models will be used for data analysis. A cluster randomised controlled trial design will be employed involving four hospitals across Changsha, Hunan Province, China. Hospitals will be randomly assigned to either the intervention group, which will receive the complex family adaptation intervention, or the control group, which will undergo a stress management course. The participants will include families of children aged 5-12 years newly diagnosed with cancer. The primary outcomes to be measured include post-traumatic stress, family adaptation, emotional reactivity, quality of life, and additional health outcomes. Assessments will be performed at baseline, post-intervention, and follow-ups at 2 and 6 months.

DISCUSSION: This project follows the MRC framework for developing and evaluating complex interventions and will use a cluster randomized controlled design to ensure methodological rigor. The multi-component, culturally tailored, family-centered intervention addresses the psychosocial needs of hospitalized pediatric cancer patients and their families in China, a population that has been under-represented in psychosocial oncology research. Targeting family adaptation, stress reduction, and quality of life, the intervention demonstrates strong feasibility and potential for integration into routine pediatric oncology care if proven effective.

TRIAL REGISTRATION: The study was registered on the Chinese Clinical Trial Registry (ChiCTR) platform, http://www.chictr.org.cn (Record ID: ChiCTR2300076764, October 18, 2023), the protocol version number: V1.0.