Effects of Person-Centered Information for Parents of Children With Cancer (the PIFBO Study): A Randomized Controlled Trial.

Background: Conveying information to parents is a core part of pediatric oncology nursing; however, most published interventions do not tailor information to individual parental needs. Objective: To evaluate the effect on parental illness-related stress of person-centered information provided to parents of children with cancer. Methods: A multicenter, unblinded randomized controlled trial with two parallel arms recruiting parents of children diagnosed within the past two months from two tertiary children's cancer centers in Sweden. Parents were randomized using sealed envelopes prepared and opened by an independent person. Parents in the intervention arm met four times with experienced nurses trained in the intervention, whereas controls received standard care. The effect of the intervention was measured five times regarding parents' illness-related stress. Secondary outcomes were psychosocial states, experiences with healthcare providers, and received information. Further, we collected process data on the intervention's content and fidelity. Results: Of the 32 parents included and analyzed in the study, 16 were randomized to the intervention, which addressed a broad variety of topics. The intervention increased parents' knowledge about the biophysiological and functional aspects of their child's illness, but it had no measurable effect on their distress. Discussion: Although fidelity to the intervention protocol was sufficient, the study was flawed by recruitment difficulties, primarily due to organizational factors, which may have prevented us from observing any possible effects on psychosocial distress. Having a person-centered perspective could be promising for future studies aimed at parents of children with cancer. (Registered at Clinicaltrials.gov, number NCT02332226.).