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

NCT04433650 | Recruiting

• 2 other identifiers: MTI2019-0011KP2018-0023
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Childhood Cancer; Communication; Symptoms and Signs

Keywords

Childhood cancer; Communication; Digital application; Intervention; Pictorial support; Symptoms and Signs

Outcome Measures

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 \[worst possible distress\]).

  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)

• Biomarkers of pain and stress in blood.

  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

  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

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

• Drug consumption

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

Study Arms (2)

Group 1

EXPERIMENTAL

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)

Group 2

EXPERIMENTAL

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)

Interventions

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.

Group 1; Group 2

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)).

You may not qualify if:

• \- Children 0-4 years

Sponsors & Collaborators

• Göteborg University: lead
• Swedish Childhood Cancer Fund: collaborator

Study Sites (1)

University of Gothenburg

Gothenburg, 40530, Sweden

RECRUITING

Related Publications (6)

• 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.

  PMID: 23924164 BACKGROUND

• 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.

  PMID: 31821552 BACKGROUND

• 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.

  PMID: 22310560 BACKGROUND

• 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.

  PMID: 31420394 BACKGROUND

• 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.

  PMID: 30683283 BACKGROUND

• 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.

  PMID: 33947726 DERIVED

Related Links

• Pictorial support in person-centred care for children

MeSH Terms

Conditions

Neoplasms; Communication; Signs and Symptoms

Condition Hierarchy (Ancestors)

Behavior; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan Nilsson, PhD

  Institute of Health and Care Sciences, University of Gothenburg, Sweden

  PRINCIPAL INVESTIGATOR

• Jonas Bergquist, Professor

  Dept of Chemistry Biomedical Centre, Uppsala University, Sweden

  STUDY DIRECTOR

Central Study Contacts

Stefan Nilsson, PhD

CONTACT

+46738538951; stefan.nilsson.4@gu.se

Joakim Öhlen, Professor

CONTACT

joakim.ohlen@fhs.gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm 1: Treatment 1 is control and treatment 2 is intervention. Arm 2: Treatment 1 is intervention and treatment 2 is control.

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: April 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

SE (1)