IntroductionThis study protocol outlines the evaluation of the pictorial support in person-centred care for children (PicPecc). PicPecc is a digital tool used by children aged 5–17 years to self-report symptoms of acute lymphoblastic leukaemia, who undergo high-dose methotrexate treatments. The design of the digital platform follows the principles of universal design using pictorial support to provide accessibility for all children regardless of communication or language challenges and thus facilitating international comparison.Methods and analysisBoth effect and process evaluations will be conducted. A crossover design will be used to measure the effect/outcome, and a mixed-methods design will be used to measure the process/implementation. The primary outcome in the effect evaluation will be self-reported distress. Secondary outcomes will be stress levels monitored via neuropeptides, neurosteroids and peripheral steroids indicated in plasma blood samples; frequency of in-app estimation of high levels of distress by the children; children's use of analgesic medicine and person centeredness evaluated via the questionnaire Visual CARE Measure. For the process evaluation, qualitative interviews will be carried out with children with cancer, their legal guardians and case-related healthcare professionals. These interviews will address experiences with PicPecc in terms of feasibility and frequency of use from the child’s perspective and value to the caseworker. Interview transcripts will be analysed using an interpretive description methodology.Ethics and disseminationEthical approval was obtained from the Swedish Ethical Review Authority (reference 2019-02392; 2020-02601; 2020-06226). Children, legal guardians, healthcare professionals, policymaking and research stakeholders will be involved in all stages of the research process according to Medical Research Council’s guidelines. Research findings will be presented at international cancer and paediatric conferences and published in scientific journals.Trial registrationClinicalTrials.gov; NCT04433650.
Research with childhood cancer has progressed greatly in recent years, resulting in much improved treatment that is more intensive. However, with this new treatment children often experience negative symptoms, and research shows that nausea is a symptom that most affects them. Pictorial support in person-centred care for children (PicPecc) is a digital picture-based tool for children who undergo treatment due to their cancer diagnosis and helps them more effectively communicate and self-report their symptoms and emotions. The aim of the study was to investigate children’s experience of (i) using mHealth in nausea management and (ii) their acceptability of using an application (App). Semi-structured interviews were conducted with eight children aged five to fifteen years. Data were analysed with qualitative content analysis. The findings were presented in three categories: 1) Communicating feelings, 2) Playfulness generated in motivation and 3) App adaptable to children’s capabilities. Using an App contributed to new opportunities for the children to participate in their care. They experienced their treatment in different ways and used different strategies to manage and distract themselves from their symptoms. Using the PicPecc App can increase healthcare staff’s understanding of how children experience nausea when they undergo chemotherapy.
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