AzTrials
AzTrials

Childhood CancerPicPeccNCT04433650

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

A study testing Pictorial support in person-centred care for children (PicPecc) in people with Childhood Cancer and Communication, run by Göteborg University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 5 to 17 years
What is being tested?
Pictorial support in person-centred care for children (PicPecc)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteSweden
Study dates
1 Mar 2021to 31 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)).

Who cannot join

  • Children 0-4 years

Trial locations and contacts

1 site in 1 country.

Sweden1 site
  • University of Gothenburg

    Gothenburg, 40530

Other trials in Sweden

About this study

Official title: 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.

Read more

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).

Read the 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).

Being tested
Pictorial support in person-centred care for children (PicPecc)
Keywords
Childhood cancer, Communication, Digital application, Intervention, Pictorial support, Symptoms and Signs
Medical subject headings
Neoplasms, Communication, Signs and Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pictorial support in person-centred care for children (PicPecc)Device

    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.

Study groups in NCT04433650
Study groupRoleWhat they receive
Group 1ExperimentalThe 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).
Receives: Device: Pictorial support in person-centred care for children (PicPecc)
Group 2ExperimentalThe 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).
Receives: Device: Pictorial support in person-centred care for children (PicPecc)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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]).

    Measured: 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 (4)
  1. Biomarkers of pain and stress in blood.

    Levels of neuropeptides, neurosteroids and peripheral steroids.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: T-1 (4 hours before treatment) - T2 (48 hours after start of treatment).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start1 Mar 2021
  3. Primary completion31 Mar 2025
  4. Study completion31 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
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)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04433650
Sponsor's protocol ID
MTI2019-0011
Other IDs
KP2018-0023
Acronym
PicPecc
Status last verified
Mar 2025
First submitted
11 Jun 2020
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Nilsson S, Bjorkman B, Almqvist AL, Almqvist L, Bjork-Willen P, Donohue D, Enskar K, Granlund M, Huus K, Hvit S. Children's voices--Differentiating a child perspective from a child's perspective. Dev Neurorehabil. 2015 Jun;18(3):162-8. doi: 10.3109/17518423.2013.801529. Epub 2013 Aug 7.

    PubMed 23924164
  • Lin B, Gutman T, Hanson CS, Ju A, Manera K, Butow P, Cohn RJ, Dalla-Pozza L, Greenzang KA, Mack J, Wakefield CE, Craig JC, Tong A. Communication during childhood cancer: Systematic review of patient perspectives. Cancer. 2020 Feb 15;126(4):701-716. doi: 10.1002/cncr.32637. Epub 2019 Dec 10.

    PubMed 31821552
  • Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.

    PubMed 22310560
  • O'Cathain A, Croot L, Duncan E, Rousseau N, Sworn K, Turner KM, Yardley L, Hoddinott P. Guidance on how to develop complex interventions to improve health and healthcare. BMJ Open. 2019 Aug 15;9(8):e029954. doi: 10.1136/bmjopen-2019-029954.

    PubMed 31420394
  • Nilsson S, Holstensson J, Johansson C, Thunberg G. Children's Perceptions of Pictures Intended to Measure Anxiety During Hospitalization. J Pediatr Nurs. 2019 Jan-Feb;44:63-73. doi: 10.1016/j.pedn.2018.10.015. Epub 2018 Nov 3.

    PubMed 30683283
  • Nilsson S, Wiljen A, Bergquist J, Chaplin J, Johnson E, Karlsson K, Lindroth T, Schwarz A, Stenmarker M, Thunberg G, Esplana L, Frid E, Haglind M, Hook A, Wille J, Ohlen J. Evaluating pictorial support in person-centred care for children (PicPecc): a protocol for a crossover design study. BMJ Open. 2021 May 4;11(5):e042726. doi: 10.1136/bmjopen-2020-042726.

    PubMed 33947726

Questions about this trial

What is this clinical trial studying?

A study testing Pictorial support in person-centred care for children (PicPecc) in people with Childhood Cancer and Communication, run by Göteborg University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04433650, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in