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

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.

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.

Study Overview

• Status: Completed
• Conditions: Sarcoma; Hematologic Diseases; Leukemia; Brain Tumor; Neurofibromatoses; Neuroblastoma
• Intervention / Treatment: Other: "My Logbook! - I know my way around!"

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 Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liesa Weiler-Wichtl, Dr.; Phone Number: 34200 +43140400; Email: liesa.weiler@meduniwien.ac.at

Study Locations

• Austria
  • Graz, Austria
    • Medical University Graz
  • Vienna, Austria, 1090
    • Medical University of Vienna
  • Vienna, Austria, 1090
    • St. Anna Kinderspital
  • Oberösterreich
    • Linz, Oberösterreich, Austria, 4021
      • Kepler Universitätsklinikum
  • Salzburg
    • St. Veit, Salzburg, Austria, 5621
      • Rehabilitationszentrum St. Veit im Pongau
• Germany
  • Bad Oeynhausen, Germany, 32549
    • Klinik Bad Oexen
  • Berlin, Germany
    • Charite - Universitatsmedizin Berlin
  • Bielefeld, Germany
    • Luca-Dethlefsen-Hilfe e.V.
  • Dresden, Germany
    • Universitätsklinikum Carl Gustav Carus Dresden
  • Hamburg, Germany
    • Universitätsklinikum Hamburg-Eppendorf
  • Mannheim, Germany
    • Universitätsklinikum Mannheim
  • Regensburg, Germany
    • Universitätsklinikum Regensburg
  • Tübingen, Germany
    • Universitätsklinikum Tübingen
  • Würzburg, Germany
    • Universitätsklinikum Würzburg
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60590
      • Universitätsklinikum Frankfurt am Main
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30625
      • Medizinische Hochschule Hannover
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45147
      • Universitätsklinikum Essen
    • Münster, Nordrhein-Westfalen, Germany, 48149
      • Universitatsklinikum Munster
  • Saarland
    • Homburg, Saarland, Germany, 66421
      • Universitätsklinikum des Saarlandes
  • Sachsen
    • Leipzig, Sachsen, Germany, 04103
      • Universitätsklinikum Leipzig
• Italy
  • Trentino-Alto Adige
    • Bolzano, Trentino-Alto Adige, Italy, 39100
      • Ospedale di Bolzano
• Switzerland
  • Bern, Switzerland
    • Inselspital, Universitätsspital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: All Patients; Since this is a single-group study, all patients are within the same arm	Other: "My Logbook! - I know my way around!"; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Medical University of Graz; Charite University, Berlin, Germany; Hannover Medical School; University Hospital, Essen; Goethe University; University Hospital Muenster; University Hospital Tuebingen; University Hospital Schleswig-Holstein; University Hospital, Saarland; Universitätsklinikum Hamburg-Eppendorf; Wuerzburg University Hospital; Universitätsmedizin Mannheim; University Hospital Erlangen; University Hospital Regensburg; Universitätsklinikum Leipzig; Universitätsklinikum Köln; Salzburger Landeskliniken; Staedtisches Klinikum Karlsruhe; University Hospital Carl Gustav Carus; Kepler University Hospital; Krankenhaus Bozen; St. Anna Kinderspital, Austria; Cnopfsche Kinderklinik, Nürnberg; Leuwaldhof St.Veit (Kinder- und Jugendreha); Klinik Bad Oexen, Germany; Luca-Dethlefsen-Hilfe e.V.; Insel Gruppe AG, University Hospital Bern

Publications and helpful links

General Publications

• Kazak AE, Abrams AN, Banks J, Christofferson J, DiDonato S, Grootenhuis MA, Kabour M, Madan-Swain A, Patel SK, Zadeh S, Kupst MJ. Psychosocial Assessment as a Standard of Care in Pediatric Cancer. Pediatr Blood Cancer. 2015 Dec;62 Suppl 5:S426-59. doi: 10.1002/pbc.25730.
• Scialla MA, Canter KS, Chen FF, Kolb EA, Sandler E, Wiener L, Kazak AE. Delivery of care consistent with the psychosocial standards in pediatric cancer: Current practices in the United States. Pediatr Blood Cancer. 2018 Mar;65(3):10.1002/pbc.26869. doi: 10.1002/pbc.26869. Epub 2017 Oct 28.
• Baxter S, Johnson M, Chambers D, Sutton A, Goyder E, Booth A. The effects of integrated care: a systematic review of UK and international evidence. BMC Health Serv Res. 2018 May 10;18(1):350. doi: 10.1186/s12913-018-3161-3.
• Schurman JV, Gayes LA, Slosky L, Hunter ME, Pino FA. Publishing quality improvement work in Clinical Practice in Pediatric Psychology: The "why" and "how to". Clinical Practice in Pediatric Psychology. 2015 Mar; 3(1):80.
• Schröder HM, Lilienthal S, Schreiber-Gollwitzer BM, Griessmeier B, Leiss U. Psychosoziale Versorgung in der Pädiatrischen Onkologie und Hämatologie. PSAPOH (Hg.). 2013.
• Stuber ML, Meeske KA, Krull KR, Leisenring W, Stratton K, Kazak AE, Huber M, Zebrack B, Uijtdehaage SH, Mertens AC, Robison LL, Zeltzer LK. Prevalence and predictors of posttraumatic stress disorder in adult survivors of childhood cancer. Pediatrics. 2010 May;125(5):e1124-34. doi: 10.1542/peds.2009-2308.
• Koch U, Mehnert A, Harter M. [Chronic somatic disorders and psychological comorbidity]. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2011 Jan;54(1):1-3. doi: 10.1007/s00103-010-1196-7. No abstract available. German.

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2020
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 17, 2020

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 7, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Genetic Diseases, Inborn; Neuromuscular Diseases; Neurodegenerative Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Peripheral Nervous System Diseases; Nervous System Neoplasms; Heredodegenerative Disorders, Nervous System; Neoplastic Syndromes, Hereditary; Neuroectodermal Tumors, Primitive; Nerve Sheath Neoplasms; Neurocutaneous Syndromes; Peripheral Nervous System Neoplasms; Neuroectodermal Tumors, Primitive, Peripheral; Hematologic Diseases; Neurofibromatoses; Neurofibromatosis 1; Neurofibroma; Neuroblastoma
• Other Study ID Numbers: 1564/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No