Clinical trial NCT04474678: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Tumor
Neurofibromatoses
Sarcoma
Leukemia
Hematologic Diseases
Neuroblastoma
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: St. Anna Kinderspital, Austria
name: Charite University, Berlin, Germany
name: Cnopfsche Kinderklinik, Nürnberg
name: Kepler University Hospital
name: University Hospital, Saarland
name: Hannover Medical School
name: Krankenhaus Bozen
name: Goethe University
name: Universitätsklinikum Hamburg-Eppendorf
name: Universitätsklinikum Leipzig
name: University Hospital Muenster
name: University Hospital Tuebingen
name: Salzburger Landeskliniken
name: Leuwaldhof St.Veit (Kinder- und Jugendreha)
name: University Hospital, Essen
name: Medical University of Graz
name: University Hospital Erlangen
name: Wuerzburg University Hospital
name: Klinik Bad Oexen, Germany
name: Universitätsklinikum Köln
name: University Hospital Schleswig-Holstein
name: University Hospital Carl Gustav Carus
name: Universitätsmedizin Mannheim
name: University Hospital Regensburg
name: Luca-Dethlefsen-Hilfe e.V.
name: Insel Gruppe AG, University Hospital Bern
name: Staedtisches Klinikum Karlsruhe
First posted: 2020-07-17
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Emotional well-being, T1
timeFrame: 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
measure: Emotional well-being, T2
timeFrame: Post to first session of the special issue (booklet) - through study completion or end of medical treatment, an average of 1 year
measure: Emotional well-being, T3
timeFrame: 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
measure: Emotional well-being, T4
timeFrame: During, post to second session of the special issue (booklet) - through study completion or end of medical treatment, an average of 1 year
measure: Emotional well-being, T5
timeFrame: During, but before completion of treatment - through study completion or end of medical treatment, an average of 1 year
measure: Knowledgeability, T1
timeFrame: 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
measure: Knowledgeability, T2
timeFrame: Post to first session of the special issue (booklet) - through study completion or end of medical treatment, an average of 1 year
measure: Knowledgeability, T3
timeFrame: 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
measure: Knowledgeability, T4
timeFrame: During, post to second session of the special issue (booklet) - through study completion or end of medical treatment, an average of 1 year
measure: Knowledgeability, T5
timeFrame: During, but before completion of treatment - through study completion or end of medical treatment, an average of 1 year
measure: Feasibility of program
timeFrame: 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 outcomes:
measure: Intelligence test
timeFrame: During the first two months from diagnosis or start of psychosocial treatment - up to three Months
measure: Strengths and Difficulties Questionnaire (SDQ; Goodman, 1999)
timeFrame: During the first two months from diagnosis or start of psychosocial treatment - up to three Months
measure: KINDLR (Ravens-Sieberer & Bullinger, 2000)
timeFrame: During the first two months from diagnosis or start of psychosocial treatment - up to three Months
measure: Questionnaire on Health Competence in Children and Adolescents, (Weiler, Fohn, Pletschko, Schwarzinger, & Leiss, 2017)
timeFrame: During the first two months from diagnosis or start of psychosocial treatment - up to three Months
measure: Medical information
timeFrame: Within the first week of treatment - up to three Months
measure: Demographic data
timeFrame: During the first two months from diagnosis or start of psychosocial treatment - up to three Months
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler Universitätsklinikum
state: Oberösterreich
city: St. Veit
country: Austria
facility: Rehabilitationszentrum St. Veit im Pongau
state: Salzburg
city: Graz
country: Austria
facility: Medical University Graz
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Vienna
country: Austria
facility: St. Anna Kinderspital
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt am Main
state: Hessen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Essen
country: Germany
facility: Universitätsklinikum Essen
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Universitätsklinikum Münster
state: Nordrhein-Westfalen
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
state: Saarland
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
state: Sachsen
city: Bad Oeynhausen
country: Germany
facility: Klinik Bad Oexen
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Bielefeld
country: Germany
facility: Luca-Dethlefsen-Hilfe e.V.
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Mannheim
country: Germany
facility: Universitätsklinikum Mannheim
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Bolzano
country: Italy
facility: Ospedale di Bolzano
state: Trentino-Alto Adige
city: Bern
country: Switzerland
facility: Inselspital, Universitätsspital Bern
Study officials:
References:
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.
citation: 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.
citation: 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.
citation: 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.
citation: Schröder HM, Lilienthal S, Schreiber-Gollwitzer BM, Griessmeier B, Leiss U. Psychosoziale Versorgung in der Pädiatrischen Onkologie und Hämatologie. PSAPOH (Hg.). 2013.
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.
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.