Supporting Patient Provider Communication in Paediatric Care

Study Overview
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Brief Summary
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Children with Cancer or congenital heart disease (CHD) experience complex, physical, psychosocial and behavioural symptoms and problems due to the illness, treatment, and medical procedures. To help children cope with their problems and prevent psychological distress, the investigators developed SiSom, a support system to help children with cancer or CHD report their symptoms and problems in an age-adjusted manner on a touch-pad, portable computer. This quasi-experimental study with 202 children age 7-12 with CHD or cancer will test the following hypotheses: When children use SiSom to report their symptoms and problems, and this information is provided to their clinicians in their outpatient consultations: Children and parents will experience less anxiety. Children and parents will be more satisfied with the outpatient visit. There will be greater congruence between children's reported symptoms and problems and those addressed by their clinicians as evidenced in documented patient care. To better understand the mechanisms by which these effects may occur, the investigators will also explore: Differences between control and experimental groups in patient-provider communication in terms of instrumental and affective behaviour, participation, initiative and person addressed; The relationships among outcomes of patient-provider communication, congruence between patients' reported symptoms and those addressed by their clinicians and children's and parents' anxiety and satisfaction; and how these relationships differ between treatment and control conditions. Finally, the investigators will investigate time requirements, ease of use and usefulness of SiSom by children and clinicians. For analyses the investigators will use inferential statistics and qualitative analyses of the video-taped consultation sessions. This study will contribute to improving patient-centred care for a particularly vulnerable population, and to a better understanding of the triadic communication and interactions among child-parent and clinician.

Official Title
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Supporting Patient Provider Communication for Children With Cancer and Congenital Heart Disease

Conditions
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Cancer, Congenital Heart Disease

Intervention / Treatment
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* Behavioral: SiSom


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 7 and 12 years. Ethnic norwegian. Undergoing treatment for cancer or diagnosed with a congenital heart disease. Exclusion Criteria: Receiving or have received radiation the brain as this may affect their abilities to use SiSom and communicate during consultations. Syndromes, mental retardation, developmental disorders, language disorders, or cognitive disorders that affect their ability to report symptoms or communicate during consultations. Other ethnic origin.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients uses the symptom assessment tool SiSom. A summary of their reported symptoms are printed out and given to the pediatrician and nurse before the consultation. The consultation is videotaped. | Behavioral: SiSom<br>* SiSom is a symptom assessment tool designed to help the child report disease specific problems.The child also report the severity of their problems. After using the tool a report is printed and given to the clinician.<br>* Other names: Symptom assessment tool;|
| No Intervention: 2<br>The control group do not use the symptom assessment tool SiSom before the consultation. The control group receives usual care and the consultation is videoptaped. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-provider communication |  | Single measure, video recording of medical consultation lasting approximately one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-provider communication |  | Single measure, video recording of medical consultation lasting approximately one hour | 
| Time requirements, ease of use |  | Single measure, after collection of all patient data | 
| Congruence between children's reported symptoms and problems and those addressed by their clinicians as evidenced in documented patient care. |  | Single measure, ten minutes post intervention | 
| State anxiety |  | 10 minutes pre and 10 minutes post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Symptom management, Symptom assessment, Patient satisfaction, Patient-provider communication