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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Brain Tumor, Neurofibromatoses, Sarcoma, Leukemia, Hematologic Diseases, Neuroblastoma

Intervention / Treatment
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* Other: My Logbook! - I know my way around!


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria experimental group: currently or formerly treated for oncological condition children/families at standard risk (Pediatric Psychosocial Preventative Health Model (PPPHM)) at least average cognitive abilities (as measured via intelligence test) Inclusion Criteria control group: currently or formerly treated for oncological condition Exclusion Criteria: non-German speaking Major vision impairments Major auditive impairments

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All Patients<br>Since this is a single-group study, all patients are within the same arm | Other: My Logbook! - I know my way around!<br>* Special issues/booklets of My Logbook - I know my way around! - Every booklet is based on evidence-based interventions. It illustrates psychosocial and interdisciplinary processes in a standardized way, resulting in a practical guide (My Logbook) to accompany the child throughout all stages of oncological treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotional well-being, T1 | 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. | 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 | 
| Emotional well-being, T2 | 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. | Post to first session of the special issue (booklet) - through study completion or end of medical treatment, an average of 1 year | 
| Emotional well-being, T3 | 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. | 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 | 
| Emotional well-being, T4 | 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. | During, post to second session of the special issue (booklet) - through study completion or end of medical treatment, an average of 1 year | 
| Emotional well-being, T5 | 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. | During, but before completion of treatment - through study completion or end of medical treatment, an average of 1 year | 
| Knowledgeability, T1 | 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. | 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 | 
| Knowledgeability, T2 | 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. | Post to first session of the special issue (booklet) - through study completion or end of medical treatment, an average of 1 year | 
| Knowledgeability, T3 | 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. | 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 | 
| Knowledgeability, T4 | 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. | During, post to second session of the special issue (booklet) - through study completion or end of medical treatment, an average of 1 year | 
| Knowledgeability, T5 | 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. | During, but before completion of treatment - through study completion or end of medical treatment, an average of 1 year | 
| Feasibility of program | Rating of feasibility of the program by medical staff | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intelligence test | 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 | During the first two months from diagnosis or start of psychosocial treatment - up to three Months | 
| Strengths and Difficulties Questionnaire (SDQ; Goodman, 1999) | The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioural screening questionnaire about 3-16 year olds. | During the first two months from diagnosis or start of psychosocial treatment - up to three Months | 
| KINDLR (Ravens-Sieberer & Bullinger, 2000) | The KINDLR is a standardized questionnaire for the assessment of quality of life in children and adolescents. | During the first two months from diagnosis or start of psychosocial treatment - up to three Months | 
| Questionnaire on Health Competence in Children and Adolescents, (Weiler, Fohn, Pletschko, Schwarzinger, & Leiss, 2017) | Questionnaire for the assessment of health competence in children and adolescents | During the first two months from diagnosis or start of psychosocial treatment - up to three Months | 
| Medical information | Diagnosis, date of diagnosis, pre-existing conditions, secondary conditions, form of treatment/therapy, psychiatric diagnoses, neurological status | Within the first week of treatment - up to three Months | 
| Demographic data | Age of patient, sex, parents' education, parents' profession, school form, mother language of patient | During the first two months from diagnosis or start of psychosocial treatment - up to three Months |