Supporting Patient Provider Communication in Paediatric Care

NCT01280227 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2017-04-06

No results posted yet for this study

Summary

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.

Conditions

  • Cancer
  • Congenital Heart Disease

Interventions

BEHAVIORAL

SiSom

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.

Sponsors & Collaborators

  • The Research Council of Norway

    collaborator OTHER
  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Cornelia M Ruland, PhD · Oslo University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2010-10-31
Completion
2016-07-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01280227 on ClinicalTrials.gov