Pictorial Support in Person-centred Care for Children (PicPecc)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-17
SponsorGöteborg University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)).
Disqualifiers
None
Trial design
Design model
Crossover
Treatments tested in this trial
Pictorial support in person-centred care for children (PicPecc)
DevicePhase 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 \[worst possible distress\]).
Time frame
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 outcomes
1
Biomarkers of pain and stress in blood.
Levels of neuropeptides, neurosteroids and peripheral steroids.
Time frame
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).2
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.
Time frame
This is evaluated on the VCM, which will be collected 48 hours after the start (T2) of the high-dose methotrexate treatment.3
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.
Time frame
T-1 (4 hours before treatment) - T2 (48 hours after start of treatment).4
Drug consumption
Drug consumption for all types of symptom relief will be recorded from the patients' medical records.
Time frame
T-1 (4 hours before treatment) - T2 (48 hours after start of treatment).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Göteborg University
Lead sponsor
Swedish Childhood Cancer Fund
Collaborator
Source ClinicalTrials.gov