Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!")

Not Applicable

Completed

• Conditions: Neuroblastoma; Neurofibromatoses; Leukemia; Sarcoma; Brain Tumor; Hematologic Diseases
• Interventions: Other: "My Logbook! - I know my way around!"

• Registration Number: NCT04474678
• Lead Sponsor: Medical University of Vienna

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.

Study Timeline

• Study First Submitted: 2020-06-23
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-17
• Study Start: 2020-09-07
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-07
• Last Update Posted: 2024-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

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Exclusion Criteria

• non-German speaking
• Major vision impairments
• Major auditive impairments

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Patients	"My Logbook! - I know my way around!"	Since this is a single-group study, all patients are within the same arm

Primary Outcome Measures

Name	Time	Method
Emotional well-being, T3	During, but before completion of treatment; prior to second session of the special issue (booklet) - through study completion or end of medical treatment, an average of 1 year	Patients' emotional well-being is evaluated using a visual array of emotional displays. Patients can choose three emotions that describe their current situation best. For analysis, emotions are categorized into positive, neutral, and negative emotions. Emotional well-being is evaluated longitudinally over multiple points of time. The diagnostic tool was developed in-house, publication is pending.
Knowledgeability, T3	During, but before completion of treatment; prior to second session of the special issue (booklet) - through study completion or end of medical treatment, an average of 1 year	Patients are asked to rate their own knowledgeability regarding treatment, illness and hospital environment on a five-point scale ranging from "beginner" to "expert". Knowledgeability is evaluated longitudinally over multiple points of time. The diagnostic tool was developed in-house.
Knowledgeability, T4	During, post to second session of the special issue (booklet) - through study completion or end of medical treatment, an average of 1 year	Patients are asked to rate their own knowledgeability regarding treatment, illness and hospital environment on a five-point scale ranging from "beginner" to "expert". Knowledgeability is evaluated longitudinally over multiple points of time. The diagnostic tool was developed in-house.
Emotional well-being, T1	Based on the medical therapy protocol, after medical consultation, prior to first session of the special issue (booklet) - through study completion or end of medical treatment, an average of 1 year	Patients' emotional well-being is evaluated using a visual array of emotional displays. Patients can choose three emotions that describe their current situation best. For analysis, emotions are categorized into positive, neutral, and negative emotions. Emotional well-being is evaluated longitudinally over multiple points of time. The diagnostic tool was developed in-house, publication is pending.
Emotional well-being, T2	Post to first session of the special issue (booklet) - through study completion or end of medical treatment, an average of 1 year	Patients' emotional well-being is evaluated using a visual array of emotional displays. Patients can choose three emotions that describe their current situation best. For analysis, emotions are categorized into positive, neutral, and negative emotions. Emotional well-being is evaluated longitudinally over multiple points of time. The diagnostic tool was developed in-house, publication is pending.
Emotional well-being, T4	During, post to second session of the special issue (booklet) - through study completion or end of medical treatment, an average of 1 year	Patients' emotional well-being is evaluated using a visual array of emotional displays. Patients can choose three emotions that describe their current situation best. For analysis, emotions are categorized into positive, neutral, and negative emotions. Emotional well-being is evaluated longitudinally over multiple points of time. The diagnostic tool was developed in-house, publication is pending.
Knowledgeability, T2	Post to first session of the special issue (booklet) - through study completion or end of medical treatment, an average of 1 year	Patients are asked to rate their own knowledgeability regarding treatment, illness and hospital environment on a five-point scale ranging from "beginner" to "expert". Knowledgeability is evaluated longitudinally over multiple points of time. The diagnostic tool was developed in-house.
Emotional well-being, T5	During, but before completion of treatment - through study completion or end of medical treatment, an average of 1 year	Patients' emotional well-being is evaluated using a visual array of emotional displays. Patients can choose three emotions that describe their current situation best. For analysis, emotions are categorized into positive, neutral, and negative emotions. Emotional well-being is evaluated longitudinally over multiple points of time. The diagnostic tool was developed in-house, publication is pending.
Knowledgeability, T1	Based on the medical therapy protocol, after medical consultation, prior to first session of the special issue (booklet) - through study completion or end of medical treatment, an average of 1 year	Patients are asked to rate their own knowledgeability regarding treatment, illness and hospital environment on a five-point scale ranging from "beginner" to "expert". Knowledgeability is evaluated longitudinally over multiple points of time. The diagnostic tool was developed in-house.
Knowledgeability, T5	During, but before completion of treatment - through study completion or end of medical treatment, an average of 1 year	Patients are asked to rate their own knowledgeability regarding treatment, illness and hospital environment on a five-point scale ranging from "beginner" to "expert". Knowledgeability is evaluated longitudinally over multiple points of time. The diagnostic tool was developed in-house.
Feasibility of program	Feasibility of program is evaluated following the second session which on average takes place one to six months after start of the treatment of the special issue (booklet). - through study completion or end of medical treatment, an average of 1 year	Rating of feasibility of the program by medical staff

Secondary Outcome Measures

Name	Time	Method
KINDLR (Ravens-Sieberer & Bullinger, 2000)	During the first two months from diagnosis or start of psychosocial treatment - up to three Months	The KINDLR is a standardized questionnaire for the assessment of quality of life in children and adolescents.
Intelligence test	During the first two months from diagnosis or start of psychosocial treatment - up to three Months	Patients are administered a standardized intelligence test, dependent on their age, e.g.; Wechsler Intelligence Scale for Children IV WISC-IV, Petermann \& Petermann, 2014 or other comparable methods due to clinical standards
Medical information	Within the first week of treatment - up to three Months	Diagnosis, date of diagnosis, pre-existing conditions, secondary conditions, form of treatment/therapy, psychiatric diagnoses, neurological status
Strengths and Difficulties Questionnaire (SDQ; Goodman, 1999)	During the first two months from diagnosis or start of psychosocial treatment - up to three Months	The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioural screening questionnaire about 3-16 year olds.
Questionnaire on Health Competence in Children and Adolescents, (Weiler, Fohn, Pletschko, Schwarzinger, & Leiss, 2017)	During the first two months from diagnosis or start of psychosocial treatment - up to three Months	Questionnaire for the assessment of health competence in children and adolescents
Demographic data	During the first two months from diagnosis or start of psychosocial treatment - up to three Months	Age of patient, sex, parents' education, parents' profession, school form, mother language of patient

Trial Locations

Locations (22)

Rehabilitationszentrum St. Veit im Pongau; 🇦🇹 St. Veit, Salzburg, Austria

Medical University of Vienna; 🇦🇹 Vienna, Austria

Kepler Universitätsklinikum; 🇦🇹 Linz, Oberösterreich, Austria

Medical University Graz; 🇦🇹 Graz, Austria

St. Anna Kinderspital; 🇦🇹 Vienna, Austria

Universitätsklinikum Frankfurt am Main; 🇩🇪 Frankfurt am Main, Hessen, Germany

Universitätsklinikum Leipzig; 🇩🇪 Leipzig, Sachsen, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Niedersachsen, Germany

Universitätsklinikum Essen; 🇩🇪 Essen, Nordrhein-Westfalen, Germany

Universitätsklinikum des Saarlandes; 🇩🇪 Homburg, Saarland, Germany

Universitätsklinikum Münster; 🇩🇪 Münster, Nordrhein-Westfalen, 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 Regensburg; 🇩🇪 Regensburg, Germany

Universitätsklinikum Tübingen; 🇩🇪 Tübingen, Germany

Ospedale di Bolzano; 🇮🇹 Bolzano, Trentino-Alto Adige, Italy

Universitätsklinikum Mannheim; 🇩🇪 Mannheim, Germany

Universitätsklinikum Würzburg; 🇩🇪 Würzburg, Germany

Inselspital, Universitätsspital Bern; 🇨🇭 Bern, Switzerland