Caregiving demands and well-being in parents of children treated with outpatient or inpatient methotrexate infusion: a report from the children's oncology group.

Parent well-being is affected by their child's oncology treatment regimen and associated caregiving demand. Parental caregiving demands and well-being were evaluated in 161 parents from 47 sites whose child was randomized to receive either a 4-hour (outpatient) or 24-hour (inpatient) methotrexate infusion during consolidation treatment for acute lymphoblastic leukemia. A majority of patients randomized to the 4-hour infusion (66.3%) received the infusion as an inpatient. The most frequently reported reasons for this were lack of an adequate outpatient facility (53.6%) and physician preference (25.0%). There were no differences between caregiving demand and well-being total scores by either randomized or actual infusion location with one exception: well-being scale fatigue scores were significantly greater (P=0.001) for parents whose child received the outpatient infusion. Mean total well-being scores for both the 24-hour arm (µ=42.6; SD 16.2) and the 4-hour arm (µ=40.6; SD 14.1) were elevated compared to healthy control populations. Additional research is needed to characterize impact of treatment setting on parental caregiving demand and well-being during their child's treatment for acute lymphoblastic leukemia. Investigators examining impact of treatment location in randomized clinical trials need to control for institutional variability in outpatient care delivery resources.

RCT Entities:   Population Interventions Outcomes