Children with cancer and their families after active treatment: analyses of biopsychosocial needs and implications for healthcare – a study protocol

Abstract

Introduction Patients and families affected by paediatric cancer experience psychosocial burden not only during active treatment but also during follow-up care. Use of health services during follow-up treatment should be organised according to patients’ and family members’ needs with regard to their physical and mental situation. This study aims (1) at analysing healthcare use (medical and psychosocial) and associated factors in follow-up care of paediatric cancer patients and (2) at investigating the psychosocial situation and support needs of children and their families during follow-up care. Based on the results, recommendations for healthcare planning and for the development of new and the optimisation of existing support offers will be derived.Methods and analysis We will conduct a prospective observational study using a naturalistic explorative design with quantitative and qualitative methods. Paediatric cancer patients in follow-up care, their parents and siblings will be invited to fill out a questionnaire at three measurement points (baseline, 6 months follow-up, 12 months follow-up; target n=252 complete data sets over all measurement points). Additionally, parents will be interviewed using a semistructured interview guideline (target n=15–20) at baseline. Quantitative data will be analysed using descriptive statistics, linear mixed models and regression models. Moreover, explorative analyses will be conducted. Qualitative data will be analysed using qualitative content analyses.Ethics and dissemination The study was approved by the Local Psychological Ethics Committee (LPEK-0281). Our findings will be published in scientific, peer-reviewed journals and presented to clinicians and researchers on conferences. To assure that results will be available to affected patients and families, a lay summary will be written and disseminated using several ways (upload on the homepage of the research group, upload on the homepage of the psychosocial working group in the Society for Paediatric Oncology/Haematology in Germany, sending to relevant patient organisations).Trial registration number DRKS00025289.