A parent-delivered foot bath intervention for Chemotherapy-related Fatigue in children with cancer: a family-centered randomized controlled trial

Abstract

Chemotherapy-related fatigue (CRF) affects 50–80% of children receiving chemotherapy and significantly impairs quality of life. Despite the family-centered care framework guiding pediatric oncology practice, evidence on parent-delivered, home-based non-pharmacological interventions for CRF remains limited. This study aimed to evaluate the effect of a parent-delivered warm-water foot bath on CRF in children aged 7–12 years undergoing chemotherapy. Methods: A two-arm parallel randomized controlled trial (NCT06529484; October 2024–May 2025) was conducted at a university hospital pediatric hematology–oncology outpatient clinic. Sixty-one children with stage 3–4 Non-Hodgkin Lymphoma (intervention, n = 29; control, n = 32) were randomized using computer-generated allocation and sequentially numbered, opaque, sealed envelopes. Following structured family education, parents delivered nightly foot baths (38–40 °C, 20 min) at home for 7 consecutive days after chemotherapy administration. Adherence and fidelity were monitored via a daily WhatsApp communication protocol. Fatigue was assessed daily using the Oncology Nursing Society Visual Fatigue Scale (ONS-VFS; primary outcome) and pre/post analysis using the Pediatric Oncology Fatigue Assessment Scale (child and parent forms). Reporting followed CONSORT 2025. Results: Median ONS-VFS scores declined significantly over the 7 days in both groups (Friedman p < 0.001 for each), from 5 (Day 1) to 2 (Day 7); between-group comparisons showed no statistically significant differences on any day (all p > 0.05). On the Pediatric Oncology Fatigue Assessment Scale, no between-group differences favored the intervention; a single child-report subscale difference favored the control group and is most plausibly attributable to multiple comparisons. Adherence was complete (100%), no adverse events occurred, and all 61 participants completed the protocol. Conclusions: A parent-delivered foot bath is a safe, feasible, and well-accepted family-centered nursing intervention, with complete adherence and no adverse events. This trial was not powered to detect between-group differences and did not demonstrate superiority over standard care; adequately powered trials are needed to determine efficacy.