Actively Recruiting

Phase Not Applicable
Age: 5Years - 17Years
All Genders
NCT04433650

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

Led by Göteborg University · Updated on 2025-04-06

40

Participants Needed

1

Research Sites

300 weeks

Total Duration

On this page

Sponsors

G

Göteborg University

Lead Sponsor

S

Swedish Childhood Cancer Fund

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 5Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children with cancer aged 5 to 17 years
  • Legal guardians of the participating children
  • Healthcare professionals caring for these children
  • Child must have cognitive ability similar to a 5-year-old to understand a numeric rating scale
Not Eligible

You will not qualify if you...

  • Children younger than 5 years old

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Gothenburg

Gothenburg, Sweden, 40530

Actively Recruiting

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Research Team

S

Stefan Nilsson, PhD

CONTACT

J

Joakim Öhlen, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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