Peer-reviewed article
An intervention for fear of progression in childhood cancer patients and their parents: feasibility and preliminary efficacy in a pilot randomised controlled trial.
Herrmann J, Kern L, Santel A, Herzog K, Kulisch LK et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This pilot randomised controlled trial tested KIPA, a family-based therapeutic intervention to reduce fear of progression in children with cancer and their parents. The study included 29 families, though only 6 children participated, with families assigned to receive the intervention or waitlist control. The intervention showed significant improvements in parents' fear of progression, anxiety, and quality of life, but had limited effects on children and mixed feasibility results, particularly low child participation and recruitment rates.
Key points
- Participation rate was 23% overall, with higher uptake during acute treatment (51%) than follow-up care (15%)
- Parental fear of progression improved significantly in the intervention group compared to control (p=.023, large effect size g=-0.855)
- Parents in the intervention group also showed significant improvements in posttraumatic stress symptoms, anxiety, and mental and physical quality of life
- Effects on children's fear of progression were not significant
- Retention rates were 71% overall but varied considerably between settings
Limitations
The study was small and underpowered, with very low child participation (n=6), making it difficult to assess effectiveness in children. The retrospective trial registration and methodological limitations mean results are preliminary and may not generalise to larger populations.
Abstract
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. In this pilot randomised controlled trial (RCT) we present results on feasibility and preliminary efficacy of the family-based therapeutic intervention "Kinder-Progredienzangst" (KIPA), targeting FoP in pediatric oncology. Methods N = 29 families with a child undergoing acute cancer treatment or follow-up care completed the program, with participation open to parents alone or to parents and children; ultimately, n = 6 children participated. Eligibility criteria included moderate or high FoP in at least one family member. Families were randomised to either an intervention group or a waitlist-control group receiving treatment as usual. KIPA consists of psychoeducation, anxiety confrontation, and resource activation. Participants completed questionnaires for FoP, anxiety, depression, HRQoL, and posttraumatic stress symptoms (PTSS) at different time points. Participation and retention rates were calculated, and 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 indicates sustainability. Effects on children's FoP were not significant. Conclusion The study showed mixed feasibility-particularly regarding child participation, follow-up enrolment and drop-out during acute treatment-highlighting the need for optimisation before larger trials. Nevertheless, the data provide initial indications that KIPA may benefit parents of children with cancer across both acute and follow-up care settings, a group highly affected by FoP. Given the methodological limitations, the efficacy results should be viewed as preliminary. To demonstrate KIPA's effectiveness, especially in children, large multicentre trials using reliable RCT designs suitable for acute care settings are needed. Trial registration The trial was retrospectively registered at the German Trial Registry (TRN: DRKS00024106, 04.05.2022).
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- KIPA (Kinder-Progredienzangst), a family-based therapeutic intervention consisting of psychoeducation, anxiety confrontation, and resource activation
- Population
- Families with a child undergoing acute cancer treatment or follow-up care; 29 families completed the program (6 children, predominantly parents)
Key finding
Parental fear of progression: significant difference between intervention and control groups (p=.023, g=-0.855)