CARE study: prospective cohort study on supportive care among paediatric oncology patients in western Kenya-a study protocol.
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INTRODUCTION: Childhood cancer presents significant challenges in low- and middle-income countries (LMICs), as survival rates remain substantially low. Supportive care, including nutritional support and infection prevention plus management, is crucial in improving outcomes of childhood cancer patients. To develop evidence-based interventions improving supportive care and survival, insight is needed into local prevalences of malnutrition, colonisation and infections, their association with clinical outcomes and the attitude of parents or legal guardians towards nutritional care and infection prevention. The overall aim of this prospective cohort study is to identify modifiable nutritional and infection-related determinants of clinical outcomes at 6 months in children with cancer (1-15 years of age) treated with curative intent at the Paediatric Oncology ward of the Shoe4Africa Children's Hospital at the Moi Teaching and Referral Hospital in Eldoret, Kenya. METHODS AND ANALYSIS: We will conduct a prospective cohort study on 150 children aged 1-15 years who are newly diagnosed with cancer and treated with curative intent. During 6 months of follow-up, we will collect clinical data, perform nutritional assessments and monitor pathogen exposure, colonisation and infections. Parents or legal guardians will receive one questionnaire to assess attitudes towards supportive care. Six-month mortality is the primary outcome. Other outcomes include the prevalence and characteristics of malnutrition, rectal colonisation with bacterial and fungal pathogens, infections and neutropenic fever episodes. Statistical analyses will include descriptive statistics, chi-square tests, logistic regression and thematic analysis. ETHICS AND DISSEMINATION: The Institutional Research and Ethics Committee has approved the study protocol (FAN: 0004674, protocol version 1.0). Informed consent from parents or legal guardians and assent from children ≥12 years will be obtained. Findings will be disseminated through peer-reviewed publications, presentations at academic conferences and engagement with local and national policymakers and stakeholders. Data from this study could guide the development of locally informed, evidence-based supportive care interventions, with the ultimate goal to improve overall survival for children with cancer in LMICs.