- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01280227
Supporting Patient Provider Communication in Paediatric Care (SiSom)
Supporting Patient Provider Communication for Children With Cancer and Congenital Heart Disease
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Oslo, Norvegia, 0027
- Rikshospitalet-Radiumhospitalet
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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.
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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.
Altri nomi:
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Nessun intervento: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Patient-provider communication
Lasso di tempo: Single measure, video recording of medical consultation lasting approximately one hour
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Single measure, video recording of medical consultation lasting approximately one hour
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Patient-provider communication
Lasso di tempo: Single measure, video recording of medical consultation lasting approximately one hour
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Single measure, video recording of medical consultation lasting approximately one hour
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Time requirements, ease of use
Lasso di tempo: Single measure, after collection of all patient data
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Single measure, after collection of all patient data
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Congruence between children's reported symptoms and problems and those addressed by their clinicians as evidenced in documented patient care.
Lasso di tempo: Single measure, ten minutes post intervention
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Single measure, ten minutes post intervention
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State anxiety
Lasso di tempo: 10 minutes pre and 10 minutes post intervention
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10 minutes pre and 10 minutes post intervention
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Cornelia M Ruland, PhD, Oslo University Hospital
Pubblicazioni e link utili
Pubblicazioni generali
- Vatne TM, Finset A, Ornes 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.
- 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. doi: 10.1016/j.jbi.2007.10.004. Epub 2007 Nov 13.
- 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.
- Slaughter LA, Ruland CM, Vatne TM. Constructing an effective information architecture for a pediatric cancer symptom assessment tool. AMIA Annu Symp Proc. 2006;2006:1102.
- 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.
- Vatne TM, Ruland CM, Ornes 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.
- 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.
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Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- S-05288
- 175389/V50
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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