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

Leukemia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04474678
• Other study ID #: 1564/2017
• Status: Completed
• Phase: N/A
• Start date: September 7, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Tumor
• Hematologic Diseases
• Leukemia
• Neuroblastoma
• Neurofibroma
• Neurofibromatoses
• Neurofibromatosis 1
• Sarcoma

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University Graz	Graz
Austria	Kepler Universitätsklinikum	Linz	Oberösterreich
Austria	Rehabilitationszentrum St. Veit im Pongau	St. Veit	Salzburg
Austria	Medical University of Vienna	Vienna
Austria	St. Anna Kinderspital	Vienna
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 Essen	Essen	Nordrhein-Westfalen
Germany	Universitätsklinikum Frankfurt am Main	Frankfurt am Main	Hessen
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover	Niedersachsen
Germany	Universitätsklinikum des Saarlandes	Homburg	Saarland
Germany	Universitätsklinikum Leipzig	Leipzig	Sachsen
Germany	Universitätsklinikum Mannheim	Mannheim
Germany	Universitätsklinikum Münster	Münster	Nordrhein-Westfalen
Germany	Universitätsklinikum Regensburg	Regensburg
Germany	Universitätsklinikum Tübingen	Tübingen
Germany	Universitätsklinikum Würzburg	Würzburg
Italy	Ospedale di Bolzano	Bolzano	Trentino-Alto Adige
Switzerland	Inselspital, Universitätsspital Bern	Bern

Sponsors (28)

Lead Sponsor

Collaborator

Medical University of Vienna

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

Countries where clinical trial is conducted

Austria,  Germany,  Italy,  Switzerland, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

Schröder HM, Lilienthal S, Schreiber-Gollwitzer BM, Griessmeier B, Leiss U. Psychosoziale Versorgung in der Pädiatrischen Onkologie und Hämatologie. PSAPOH (Hg.). 2013.

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.

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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