An intervention for Fear of Progression in Childhood Cancer Patients and their Parents: Results of a Pilot Randomized Trial

Background : Fear of progression (FoP) is a significant psychosocial burden for children with cancer and their parents, influencing their quality of life (HRQoL) and emotional adjustment. There is a lack of helpful therapeutic interventions in pediatric oncology. We have developed the family-based intervention “Kinder-Progredienzangst” (KIPA, engl.: children FoP) and investigated its feasibility and efficacy. Methods : In this pilot randomized controlled trial (RCT) 29 families with a child diagnosed with cancer and undergoing acute treatment or follow-up care participated. Eligibility criteria included moderate or high FoP in at least one family member. Families were randomized to either an intervention group or a waitlist-control group receiving treatment as usual. KIPAconsists of psychoeducation, anxiety confrontation, and resource activation. Participants completed questionnaires for FoP, anxiety, depression, HRQoL, and posttraumatic stress symptoms (PTSS) at different time points. The aim of the study was to assess participation and retention rates as well as the efficacy of KIPA. We used Mann-Whitney U tests for between-group comparisons, Friedman and Wilcoxon tests for within-group comparisons and Hedges g for effect sizes. Results : Feasibility results showed a participation rate of 23%, with higher participation in acute treatment (51%) compared to follow-up care (15%). Retention rates were 71% overall, with significant variability between settings. Efficacy analyses revealed significant differences in parental FoP between study conditions with high effect size ( W =65.5, p =.023, g =-0.855). Improvements were also noted in PTSS ( W =33, p <.001, g =-1.365), anxiety ( W =59, p =.017, g =-0.906) and mental ( W =217, p <.001, g =1.619) and physical ( W =180, p =.042, g =0.834) HRQoL. The pre-post analysis showed a significant reduction in parental FoP in both settings, and the follow-up data indicate sustainability. Effects on children’s FoP were less pronounced, with trends suggesting indirect benefits from reduced parental distress. Conclusion : KIPA demonstrates feasibility and promising efficacy in reducing FoP among parents of pediatric oncology patients. The findings highlight the challenges of enrollment, particularly in children, and the importance of considering family dynamics. Future research should focus on optimising recruitment strategies and evaluating effects in larger multicenter trials. The trial was retrospectively registered at the German Trail Registry (TRN: DRKS00024106, 04.05.2022).