NCT04433650 Pictorial Support in Person-centred Care for Children (PicPecc)
| NCT ID | NCT04433650 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Göteborg University |
| Condition | Childhood Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2021-04-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Stefan Nilsson, PhD
PRINCIPAL INVESTIGATOR
Institute of Health and Care Sciences, University of Gothenburg, Sweden
Frequently Asked Questions
Who can join the NCT04433650 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 17 Years, studying Childhood Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04433650 currently recruiting?
Yes, NCT04433650 is actively recruiting participants. Contact the research team at stefan.nilsson.4@gu.se for enrollment information.
Where is the NCT04433650 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT04433650 clinical trial?
NCT04433650 is sponsored by Göteborg University. The principal investigator is Stefan Nilsson, PhD at Institute of Health and Care Sciences, University of Gothenburg, Sweden. The trial plans to enroll 40 participants.
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