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.
Sponsor study identifier
interventional
240
4 countries
22
Study Start
September 7, 2020
Actual (reported)Primary Completion
December 31, 2023
Actual (reported)Study Completion
December 31, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 23, 2020
Actual (reported)July 17, 2020
Actual (reported)September 7, 2020
Actual (reported)December 31, 2023
Actual (reported)December 31, 2023
Actual (reported)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
Since this is a single-group study, all patients are within the same arm
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Rehabilitationszentrum St. Veit im Pongau
Sankt Veit im Pongau, State of Salzburg, 5621, Austria
Kepler Universitätsklinikum
Linz, Upper Austria, 4021, Austria
Medical University Graz
Graz, Austria
Medical University of Vienna
Vienna, 1090, Austria
St. Anna Kinderspital
Vienna, 1090, Austria
Universitätsklinikum Frankfurt am Main
Frankfurt am Main, Hesse, 60590, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625, Germany
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.
240 participants (actual enrollment reported by the registry).
First Submitted
June 23, 2020
First Posted
July 17, 2020
Study Start
September 7, 2020
Actual (reported)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
Intelligence test
During the first two months from diagnosis or start of psychosocial treatment - up to three Months
Strengths and Difficulties Questionnaire (SDQ; Goodman, 1999)
During the first two months from diagnosis or start of psychosocial treatment - up to three Months
KINDLR (Ravens-Sieberer & Bullinger, 2000)
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)
During the first two months from diagnosis or start of psychosocial treatment - up to three Months
Medical information
Within the first week of treatment - up to three Months
Contact the study team to confirm eligibility.
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45147, Germany
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149, Germany
Universitätsklinikum des Saarlandes
Homburg, Saarland, 66421, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103, Germany
Klinik Bad Oexen
Bad Oeynhausen, 32549, 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 Mannheim
Mannheim, Germany
Universitätsklinikum Regensburg
Regensburg, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Universitätsklinikum Würzburg
Würzburg, Germany
Ospedale di Bolzano
Bolzano, Trentino-Alto Adige, 39100, Italy
Inselspital, Universitätsspital Bern
Bern, Switzerland
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.
Schreiber-Gollwitzer BM, Schroder HM, Griessmeier B, Labouvie H, Lilienthal S; PSAPOH. [Quantitative and qualitative evaluation of psychosocial care for patients in pediatric oncology and hematology--a multicenter study on behalf of the PSAPOH]. Klin Padiatr. 2003 May-Jun;215(3):171-6. doi: 10.1055/s-2003-39377. German.
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.
Weiler-Wichtl LJ, Fohn-Erhold V, Rosenmayr V, Hansl R, Hopfgartner M, Fries J, Schneider C, Herzog K, Neumann K, Schellenberg T, Schonenberger-Loppacher D, Faist-Schweika C, Schonthaler B, Stember N, Wiegele K, Reddig M, Paduch A, Lein-Kohler I, Hoffmann R, Kollmann A, Just U, Salzmann N, Gerhardt M, Essl S, Borbely J, Kopper M, Pal-Handl K, Wasinger-Brandweiner V, Rinner S, Schubert L, Lange S, Leiss U. "MyLogbook-I Know My Way Around": A Psychological Therapy Program to Enhance Health Literacy and Positive Emotional Adjustment in Pediatric Oncology. Psychooncology. 2026 Aug;35(8):e70577. doi: 10.1002/pon.70577.
Weiler-Wichtl LJ, Fohn-Erhold V, Rosenmayr V, Hansl R, Hopfgartner M, Pal-Handl K, Wasinger-Brandweiner V, Herzog K, Neumann K, Schellenberg T, Schonenberger-Loppacher D, Faist-Schweika C, Schonthaler B, Budich M, Stember N, Wiegele K, Reddig M, Paduch A, Lein-Kohler I, Gorgen S, Wienands H, Gauf H, Hoffmann R, Kollmann A, Just U, Salzmann N, Neunsinger P, Gerhardt M, Essl S, Borbely J, Kopper M, Rinner S, Schubert L, Leiss U. Benefits of applying standardized frameworks to implement psychosocial tools such as the 'My Logbook'. Support Care Cancer. 2024 Nov 14;32(12):789. doi: 10.1007/s00520-024-08981-7.
Weiler-Wichtl LJ, Fohn-Erhold V, Rosenmayr V, Hansl R, Hopfgartner M, Fries J, Schneider C, Herzog K, Schellenberg T, Schonthaler B, Stember N, Lein-Kohler I, Hoffmann R, Kollmann A, Salzmann N, Essl S, Pal-Handl K, Wasinger-Brandweiner V, Rinner S, Schubert L, Lange S, Leiss U. Preparing Children for Invasive Medical Cancer Treatment with "My Logbook": Preliminary Results of a Pilot Study. J Cancer Educ. 2025 Feb;40(1):132-141. doi: 10.1007/s13187-024-02481-2. Epub 2024 Aug 7.
Primary Completion
December 31, 2023
Actual (reported)Study Completion
December 31, 2023
Actual (reported)Last Updated
January 9, 2024
Record last verified: 2024-01
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