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Brief Title: Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!")
Official Title: A Quality Improvement Project to Implement Psychosocial Care Standards in Clinical Practice in Pediatric Oncology "My Logbook! - I Know my Way Around!" ("Mein Logbuch - Ich Kenne Mich Aus!") Development and Evaluation of a Consensus and Evidence Based Psychosocial Therapy Tool in a Preliminary Psychosocial Study on Therapy Optimization.
Study ID: NCT04474678
Brief Summary: In this study, the main goal is to implement and evaluate a novel, evidence-based psycho-educative program for children in oncological care. Patients are provided with booklets tailored to each specific stage of their treatment. Among other factors, children's emotional well-being is evaluated as well as feasibility. The study is carried out at multiple sites across Austria, Germany and Italy/South Tirol.
Detailed Description: It is well documented that the prevalence of mental disorders in childhood cancer survivors is twice to quadruple compared to healthy controls. Effects range from impaired emotional balance, fear of recidivisms, helplessness, depression to post traumatic stress disorder. As a basis for interventions to preventively address these issues and moreover, to achieve defined psychosocial goals in the field of paediatric oncology, guidelines and standards systematically describe stressors and resources in particularly challenging situations. Nevertheless, despite these guidelines, actual care is quite heterogenous due to differences in setting, provision and profession. Studies show that integrated models of psychosocial care yield better outcomes. Integrated care systems can enhance patient satisfaction, increase perceived quality of care, and enable access to services and reduce service costs. Highly complex, system-wide interventions such as models of integrated care represent considerable challenges for operationalisation of relevant factors and evaluation of whole processes compared to single interventions (e.g. relaxation techniques). Quality improvement (QI) is an iterative process designed to make controlled changes within the health care delivery system to provide patients with high-quality care that meets both their expectations and needs. In terms of quality assurance, this QI Project aims to operationalize recommendations of the S3 guideline for psychosocial care which results in a combined process- and patient-oriented intervention and evaluation tool - bridging the gap between standards/evidence and clinical practice. The "Onco-Mini-Version" of "My Logbook - I know my way around" already comprises a Starter-Kit and 8 booklets, which cover at least one main issue of every treatment phase: initial contact, medical assessment (MRI), supportive therapy (chemotherapy, radio therapy), rehabilitation and after-care. All interventions are carried out by a clinical psychologist or psychosocial staff specialized in pediatric psychooncology and are understood as part of an integrated care system. Every booklet provides practical materials with enhanced stimulating elements to encourage the child to explore actively. The booklets are structured in two face-to-face sessions covering psychoeducational, activity \& practice and reflective aspects. The core of this QI project is a multilevel and interdisciplinary approach characterized by iterative processes. PDSA (Plan, Do, Study, Act) cycles were applied in all steps of conceptualization and implementation of this project. It aims to systematically improve psychosocial care of pediatric cancer patients through being implemented in a large number of hospitals in the German-speaking world. The proposed multicenter pilot phase promotes emotional well-being and level of information of the child during treatment through transfer of knowledge and coping skills. Moreover, it addresses feasibility of the tool but also the impact of medical procedures on feasibility. In the long term, the program is intended to help attenuate psychological late effects of oncological conditions and their treatments.
Minimum Age: 6 Years
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Kepler Universitätsklinikum, Linz, Oberösterreich, Austria
Rehabilitationszentrum St. Veit im Pongau, St. Veit, Salzburg, Austria
Medical University Graz, Graz, , Austria
Medical University of Vienna, Vienna, , Austria
St. Anna Kinderspital, Vienna, , Austria
Universitätsklinikum Frankfurt am Main, Frankfurt am Main, Hessen, Germany
Medizinische Hochschule Hannover, Hannover, Niedersachsen, Germany
Universitätsklinikum Essen, Essen, Nordrhein-Westfalen, Germany
Universitätsklinikum Münster, Münster, Nordrhein-Westfalen, Germany
Universitätsklinikum des Saarlandes, Homburg, Saarland, Germany
Universitätsklinikum Leipzig, Leipzig, Sachsen, Germany
Klinik Bad Oexen, Bad Oeynhausen, , Germany
Charité - Universitätsmedizin Berlin, Berlin, , Germany
Luca-Dethlefsen-Hilfe e.V., Bielefeld, , Germany
Universitätsklinikum Carl Gustav Carus Dresden, Dresden, , Germany
Universitätsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Universitätsklinikum Mannheim, Mannheim, , Germany
Universitätsklinikum Regensburg, Regensburg, , Germany
Universitätsklinikum Tübingen, Tübingen, , Germany
Universitätsklinikum Würzburg, Würzburg, , Germany
Ospedale di Bolzano, Bolzano, Trentino-Alto Adige, Italy
Inselspital, Universitätsspital Bern, Bern, , Switzerland