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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Oslo、ノルウェー、0027
- Rikshospitalet-Radiumhospitalet
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:非ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的: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.
他の名前:
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介入なし: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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Patient-provider communication
時間枠: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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二次結果の測定
結果測定 |
時間枠 |
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Patient-provider communication
時間枠: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
時間枠: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.
時間枠:Single measure, ten minutes post intervention
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Single measure, ten minutes post intervention
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State anxiety
時間枠:10 minutes pre and 10 minutes post intervention
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10 minutes pre and 10 minutes post intervention
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Cornelia M Ruland, PhD、Oslo University Hospital
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
癌の臨床試験
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