Overview

This trial is active, not recruiting.

Conditions cancer, congenital heart disease
Treatment sisom
Sponsor Oslo University Hospital
Collaborator The Research Council of Norway
Start date January 2005
End date October 2010
Trial size 144 participants
Trial identifier NCT01280227, 175389/V50, S-05288

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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.
sisom Symptom assessment tool
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.
(No Intervention)
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.

Primary Outcomes

Measure
Patient-provider communication
time frame: Single measure, video recording of medical consultation lasting approximately one hour

Secondary Outcomes

Measure
Patient-provider communication
time frame: Single measure, video recording of medical consultation lasting approximately one hour
Time requirements, ease of use
time frame: 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.
time frame: Single measure, ten minutes post intervention
State anxiety
time frame: 10 minutes pre and 10 minutes post intervention

Eligibility Criteria

Male or female participants from 7 years up to 12 years old.

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.

Additional Information

Official title Supporting Patient Provider Communication for Children With Cancer and Congenital Heart Disease
Principal investigator Cornelia M Ruland, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Oslo University Hospital.