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

February 26, 2024 updated by: Göteborg University

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Gothenburg, Sweden, 40530
        • Recruiting
        • University of Gothenburg
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1

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)

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.
Experimental: Group 2

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)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change is being assessed in self-reported 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).
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.
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).
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
Time Frame: This is evaluated on the VCM, which will be collected 48 hours after the start (T2) of the high-dose methotrexate treatment.
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
Time Frame: T-1 (4 hours before treatment) - T2 (48 hours after start of treatment).
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
Time Frame: T-1 (4 hours before treatment) - T2 (48 hours after start of treatment).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Collaborators

Swedish Childhood Cancer Fund

Investigators

  • Principal Investigator: Stefan Nilsson, PhD, Institute of Health and Care Sciences, University of Gothenburg, Sweden
  • Study Director: Jonas Bergquist, Professor, Dept of Chemistry Biomedical Centre, Uppsala University, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

June 11, 2020

First Submitted That Met QC Criteria

June 14, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MTI2019-0011
  • KP2018-0023 (Other Grant/Funding Number: SA2018-7681)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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