Supporting Patient Provider Communication in Paediatric Care

Cancer Clinical Trial

— SiSom  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01280227
• Other study ID #: S-05288
• Secondary ID: 175389/V50
• Status: Completed
• Phase: N/A
• First received: September 1, 2009
• Last updated: April 5, 2017
• Start date: January 2005
• Est. completion date: July 2016

Study information

• Verified date: April 2017
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: July 2016
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
Norway	Rikshospitalet-Radiumhospitalet	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	The Research Council of Norway

Country where clinical trial is conducted

Norway, 

References & Publications (7)

Ruland CM, Slaughter L, Starren J, Vatne TM, Moe EY. Children's contributions to designing a communication tool for children with cancer. Stud Health Technol Inform. 2007;129(Pt 2):977-82. — View Citation

Ruland CM, Slaughter L, Starren J, Vatne TM. Children as design partners in the development of a support system for children with cancer. Stud Health Technol Inform. 2006;122:80-5. — View Citation

Ruland CM, Starren J, Vatne TM. Participatory design with children in the development of a support system for patient-centered care in pediatric oncology. J Biomed Inform. 2008 Aug;41(4):624-35. Epub 2007 Nov 13. — View Citation

Slaughter LA, Ruland CM, Vatne TM. Constructing an effective information architecture for a pediatric cancer symptom assessment tool. AMIA Annu Symp Proc. 2006:1102. — View Citation

Vatne TM, Finset A, Ørnes K, Ruland CM. Application of the verona coding definitions of emotional sequences (VR-CoDES) on a pediatric data set. Patient Educ Couns. 2010 Sep;80(3):399-404. doi: 10.1016/j.pec.2010.06.026. — View Citation

Vatne TM, Ruland CM, Ørnes K, Finset A. Children's expressions of negative emotions and adults' responses during routine cardiac consultations. J Pediatr Psychol. 2012 Mar;37(2):232-40. doi: 10.1093/jpepsy/jsr074. Epub 2011 Sep 9. — View Citation

Vatne TM, Slaugther L, Ruland CM. How children with cancer communicate and think about symptoms. J Pediatr Oncol Nurs. 2010 Jan-Feb;27(1):24-32. doi: 10.1177/1043454209349358. Epub 2009 Oct 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-provider communication		Single measure, video recording of medical consultation lasting approximately one hour
Secondary	Patient-provider communication		Single measure, video recording of medical consultation lasting approximately one hour
Secondary	Time requirements, ease of use		Single measure, after collection of all patient data
Secondary	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
Secondary	State anxiety		10 minutes pre and 10 minutes post intervention