Supporting Patient Provider Communication in Paediatric Care (SiSom)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Oslo University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01280227
First received: September 1, 2009
Last updated: January 19, 2011
Last verified: January 2011
  Purpose

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.


Condition Intervention
Cancer
Congenital Heart Disease
Behavioral: SiSom

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Supporting Patient Provider Communication for Children With Cancer and Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Patient-provider communication [ Time Frame: Single measure, video recording of medical consultation lasting approximately one hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient-provider communication [ Time Frame: Single measure, video recording of medical consultation lasting approximately one hour ] [ Designated as safety issue: No ]
  • Time requirements, ease of use [ Time Frame: Single measure, after collection of all patient data ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • State anxiety [ Time Frame: 10 minutes pre and 10 minutes post intervention ] [ Designated as safety issue: No ]

Enrollment: 144
Study Start Date: January 2005
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
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 Name: Symptom assessment tool
No Intervention: 2
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.

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01280227

Locations
Norway
Rikshospitalet-Radiumhospitalet
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
The Research Council of Norway
Investigators
Principal Investigator: Cornelia M Ruland, PhD Oslo University Hospital
  More Information

No publications provided

Responsible Party: The Research Council of Norway
ClinicalTrials.gov Identifier: NCT01280227     History of Changes
Other Study ID Numbers: S-05288, 175389/V50
Study First Received: September 1, 2009
Last Updated: January 19, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Oslo University Hospital:
Symptom management
Symptom assessment
Patient satisfaction
Patient-provider communication

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on October 19, 2014