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Evaluating pictorial support in person-centred care for children (PicPecc): a protocol for a crossover design study
Stefan Nilsson1, Angelica Wiljén2, Jonas Bergquist3
1University of Gothenburg Centre for Person-Centred Care, and Institute of Health and Care Sciences, University of Gothenburg, Gothenburg, Sweden stefan.nilsson.4@gu.se.
Insights
This study evaluates the Pictorial Support in Person-Centred Care for Children (PicPecc) tool for pediatric cancer patients. PicPecc aims to improve symptom reporting and care accessibility for children undergoing treatment.
Area of Science:
- Pediatric Oncology
- Digital Health Interventions
- Patient-Reported Outcomes
Background:
- Acute lymphoblastic leukemia treatment, particularly high-dose methotrexate, can cause significant distress in children.
- Effective symptom monitoring and person-centered care are crucial for improving pediatric cancer patient outcomes.
- Existing tools may not adequately address communication or language challenges in diverse pediatric populations.
Purpose of the Study:
- To evaluate the effectiveness and implementation of the Pictorial Support in Person-Centred Care for Children (PicPecc) digital tool.
- To assess PicPecc's impact on self-reported distress and other secondary outcomes in children aged 5-17 undergoing cancer treatment.
- To explore the feasibility, usability, and perceived value of PicPecc from the perspectives of children, guardians, and healthcare professionals.
Main Methods:
- A mixed-methods approach incorporating a crossover design for effect evaluation and qualitative interviews for process evaluation.
- Effect evaluation primary outcome: self-reported distress. Secondary outcomes include stress biomarkers, distress estimation frequency, analgesic use, and person-centeredness (Visual CARE Measure).
- Process evaluation involves qualitative interviews with children, guardians, and healthcare professionals, analyzed using interpretive description.
Main Results:
- (Study protocol; results pending) The study is designed to measure the impact of PicPecc on pediatric cancer patients' distress levels.
- (Study protocol; results pending) Secondary outcome measures will provide comprehensive data on physiological stress, treatment adherence, and care quality.
- (Study protocol; results pending) Qualitative data will offer insights into the practical application and user experience of the PicPecc tool.
Conclusions:
- (Study protocol; conclusions pending) The PicPecc tool has the potential to enhance person-centered care and symptom reporting for children with cancer.
- (Study protocol; conclusions pending) Findings will inform the broader implementation of accessible digital health tools in pediatric oncology.
- (Study protocol; conclusions pending) This research emphasizes the importance of universal design principles in developing supportive technologies for vulnerable pediatric populations.
Introduction:
This 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 Analysis:
Both 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 Dissemination:
Ethical 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 Registration:
ClinicalTrials.gov; NCT04433650.
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