Pictorial Support in Person-centred Care for Children (PicPecc)

Study Overview
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Brief Summary
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Introduction: Person-centred care is based on the assumption that every person has resources that should be used in the care situation. In order for this to happen the patient has to be able to effectively communicate his/her symptoms. This protocol describes the analysis of a digital picture-based tool for communication support for children with cancer aged 5-17 years, who undergo high-dose methotrexate treatment. The advantage of a non-linguistic based platform, beside the expected clinical outcomes, is that it can be used in multiple national studies with minimal translation. Methods and analysis: Two studies will be conducted in a hybrid design, i.e., a crossover design will be used for the intervention (effects), and a mixed-methods design will be used for the process evaluation. Qualitative interviews will be carried out with children with cancer, their legal guardians and case-related healthcare professionals as part of the process evaluation. The interviews will address the experiences of the intervention and frequency of use from the child's perspective. Interview transcripts will be analyzed qualitative descriptively. The digital communication tool will collect child self-reports of symptoms/emotions. The children will be monitored for biomarkers of stress and pain (neuropeptides, neurosteroids and peripheral steroids) in venous blood samples, in-app estimation levels for the children, drug consumption. Person-centeredness will be evaluated with the questionnaire Visual CARE Measure. Ethics: Ethical approval was obtained from the Swedish Ethical Review Authority (ref 2019-02392; 2020-02601).

Detailed Description
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BACKGROUND Failure in symptom relief in children with cancer leads to physical and emotional distress. Success in symptom relief is assumed to decrease distress. To initiate a person-centred approach to child-centred care means to elucidate, listen to and affirm the child´s story. Assessments of distress and symptoms are essential in symptom relief for children with cancer. However, the exclusive assessment of pain intensity can be considered a restrictive description of the experience. Novel assessment tools that give a broader description of symptoms are needed. Self-reports of symptoms are the gold standard for measuring symptoms, and strategies to achieve symptom relief to represent a dynamic and interactive process. A complex intervention has been chosen, and the project follows the Medical Research Council´s key principles and actions for consideration in the developing of the intervention. AIM This project aims to investigate whether a person-centred communication intervention employing a new digital communication tool for children undergoing cancer treatment decrease the children's self-reported distress Research questions: Does adding a digital reporting and communication tool, decrease distress in children with cancer, aged 5-17 years, who undergo high-dose methotrexate treatment? Does the adding of a digital reporting and communication tool, increase person-centredness in children with cancer, aged 5-17 years, who undergo high-dose methotrexate treatment? Hypothesis: (i) Person-centred communication with children undergoing cancer treatment, applying a digital reporting and communication tool, will lead to reduced self-reported distress on an analogue assessment tool (paper sheet) (primary outcome), a decrease in neuropeptides, neurosteroids and peripheral steroids for stress and pain in blood, and an increased person-centeredness (secondary outcomes) (effect). (ii) The person-centred communication is performed in child-centred ways to proactively assess children's symptoms (process) and will be evaluated with frequency of use and feasibility. METHODS/DESIGN Study design The children will participate in a cross-over design where they are their own controls. This is a hybrid design, which evaluates both the effects and the implementation (process). The participant is given a code in a predetermined order; the code shows whether he or she should start either with intervention (application) or with the control conditions. Randomization of the codes occurs in advance at randomizer.org, and the researcher always picks the codes in a predetermined order without knowing if it is intervention or control. This is revealed when the participant has agreed to participate in the study. Participating children participate twice, once as a control and once with e-health support Pictorial support in Person-centered care for children (PicPecc).

Official Title
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A Person-centred Approach to Pictorial Support in Care for Children (PicPecc)

Conditions
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Childhood Cancer, Communication, Symptoms and Signs

Intervention / Treatment
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* Device: Pictorial support in person-centred care for children (PicPecc)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with cancer, 5-17 years The children´s legal guardians Healthcare professionals who take care of these children The child needs to have a cognitive level of approximately five years (i.e., be able to understand a numeric rating scale (NRS)). Exclusion Criteria: - Children 0-4 years

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Arm 1: Treatment 1 is control and treatment 2 is intervention. Arm 2: Treatment 1 is intervention and treatment 2 is control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>The child will firstly undergo phase A without the digital reporting and communication tool. The child will secondly undergo phase B with the digital reporting and communication tool (i.e., A, B). | Device: Pictorial support in person-centred care for children (PicPecc)<br>* Phase A: The child has the protocol for methotrexate treatment, the healthcare professionals have one workshop that containing person-centred care, universal design, distress, symptom management and the digital reporting and communication tool. Phase B: The child has everything in phase A. In addition, the child use the digital reporting and communication tool that has a thermometer (graded from zero (green) to ten (red)). The result of the assessment is visualized as a face (mimic and colour represents the intensity of the symptom and/or emotion (i.e., anxiety, appetite, fear/worries, how I´m feeling today, nausea, pain, sleep, and tiredness)). The digital reporting and communication tool has a body figure for location of pain, pictures for the type of pain, and an open question. There is an avatar and a gamification part, e.g., the child gets a pet after assessing the symptoms/emotions. The child reports in the app, and the child decides the frequency of assessments.<br>|
| Experimental: Group 2<br>The child will firstly undergo phase B with the digital reporting and communication tool. The child will secondly undergo phase A without the digital reporting and communication tool (i.e., B, A). | Device: Pictorial support in person-centred care for children (PicPecc)<br>* Phase A: The child has the protocol for methotrexate treatment, the healthcare professionals have one workshop that containing person-centred care, universal design, distress, symptom management and the digital reporting and communication tool. Phase B: The child has everything in phase A. In addition, the child use the digital reporting and communication tool that has a thermometer (graded from zero (green) to ten (red)). The result of the assessment is visualized as a face (mimic and colour represents the intensity of the symptom and/or emotion (i.e., anxiety, appetite, fear/worries, how I´m feeling today, nausea, pain, sleep, and tiredness)). The digital reporting and communication tool has a body figure for location of pain, pictures for the type of pain, and an open question. There is an avatar and a gamification part, e.g., the child gets a pet after assessing the symptoms/emotions. The child reports in the app, and the child decides the frequency of assessments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change is being assessed in self-reported distress | The primary outcome measure is change from baseline (T0) to 48 hours after (T2) on an 11-point NRS (0 [no distress] and 10 [worst possible distress]). | The self-reported distress will be collected four hours before high-dose methotrexate (T-1), when the treatment start (T0), after 24 hours (T1) and after 48 hours (T2). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers of pain and stress in blood. | Levels of neuropeptides, neurosteroids and peripheral steroids. | will be collected before start (T-1, T0) of the high-dose methotrexate treatment, 24 hours after start (T1), and 48 hours after start (T2). | 
| Visual CARE Measure | The purpose of VCM is to give legal guardians of children <7 years old (VCM 10Q-Legal guardians), children aged 7-11 years (VCM 5Q) and adolescents aged 12 years and over (VCM 10Q) the opportunity to share their views about their experiences regarding both the meeting with the healthcare professional and their participation. If the child or the adolescent have linguistic and/or cognitive difficulties, the questionnaire for the legal guardian (10Q-Legal guardians) will be used. | This is evaluated on the VCM, which will be collected 48 hours after the start (T2) of the high-dose methotrexate treatment. | 
| Frequency of assessments of symptoms | The A phase, we will use a checklist, and in the B phase, we will record in-app. assessment levels. | T-1 (4 hours before treatment) - T2 (48 hours after start of treatment). | 
| Drug consumption | Drug consumption for all types of symptom relief will be recorded from the patients' medical records. | T-1 (4 hours before treatment) - T2 (48 hours after start of treatment). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Childhood cancer, Communication, Digital application, Intervention, Pictorial support, Symptoms and Signs