Evaluating pictorial support in person-centred care for children (PicPecc): a protocol for a crossover design study

Abstract

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.

Child‐centered communication interventions in pediatric oncology: A scoping review and proposed new communication model

“…Following title and abstract screening, we identified and retrieved the full‐text of 34 studies and identified only one published study and two ongoing studies from clinical trial records that met inclusion criteria (Figure 1). 29–31 …”

“…The intervention is being evaluated in a single group pre–post design with follow‐up assessment on, for example, family communication and the child's quality of life 2 and 6 months after baseline. The second study is evaluating the “Pictorial Support in Person‐centered Care for Children” intervention with 40 families of children with cancer aged 5–17 years during methotrexate treatment 31 . The intervention consists of a pictorial digital reporting and communication tool that focuses on the child's reporting of symptoms including, for example, anxiety, nausea, pain, and sleep using a thermometer and body figure.…”

“…Following title and abstract screening, we identified and retrieved the full-text of 34 studies and identified only one published study and two ongoing studies from clinical trial records that met inclusion criteria (Figure 1). [29][30][31] The single published study examined the feasibility of a communication tool (MyPref) to assist clinicians in informing adolescents about cancer treatment options and facilitate shared decision-making. 29 In a mixed-methods intervention-only design, a total of 34 participants (15 adolescents and young adults [AYAS] at the age of 15-28 years, seven parents or trusted persons, and 12 healthcare professionals) used the MyPref communication tool (a questionnaire identifying patient and parent preferences followed by a dialogue based on the questionnaire response) and provided feedback through semi structured interviews (Table 1).…”

“…We further identified two ongoing studies that are testing communication interventions in pediatric oncology patients. 30,31 The first study is evaluating the "Family Talk Intervention" in 27 families of children with cancer at the age of 6-19 years. 30 The intervention consists of six sessions for the whole family and for individual members and…”

“…Even though child‐centered communication has been emphasized in pediatric oncology for several decades, our results underscore that research in this area is still limited and a systematic approach to communicating about cancer treatment and prognosis with children is still lacking. Only two ongoing studies were identified: one focusing on illness communication in families 30 and the other on communication between children and health professionals about symptoms during chemotherapy treatment 31 . Results from these studies will be important for the further development of child‐centered care.…”