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OpenTrials
Completed

NCT Number: NCT01280227

Supporting Patient Provider Communication in Paediatric Care

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SiSom

Behavioral

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.

Other names: Symptom assessment tool

Primary outcomes

  1. Patient-provider communication

    Time frame: Single measure, video recording of medical consultation lasting approximately one hour

Secondary outcomes

  1. Patient-provider communication

    Time frame: Single measure, video recording of medical consultation lasting approximately one hour

  2. Time requirements, ease of use

    Time frame: Single measure, after collection of all patient data

  3. Congruence between children's reported symptoms and problems and those addressed by their clinicians as evidenced in documented patient care.

    Time frame: Single measure, ten minutes post intervention

  4. State anxiety

    Time frame: 10 minutes pre and 10 minutes post intervention

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • The Research Council of Norway

Registry information

Official study title

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

Acronym: SiSom

Important dates

Study start
2005
Primary completion
2010
Study completion
2016
First posted
Jan 20, 2011
Registry last updated
Apr 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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