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

NCT04474678 | Completed

• 1 other identifier: 1564/2017
• Study Type: interventional
• Target: 240
• Locations: 4 countries
• Sites: 22

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.

Conditions

Brain Tumor; Neurofibromatoses; Sarcoma; Leukemia; Hematologic Diseases; Neuroblastoma

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (6)

• 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

Study Arms (1)

All Patients

OTHER

Since this is a single-group study, all patients are within the same arm

Other: "My Logbook! - I know my way around!"

Interventions

"My Logbook! - I know my way around!" OTHER

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.

All Patients

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)
• currently or formerly treated for oncological condition

You may not qualify if:

• non-German speaking
• Major vision impairments
• Major auditive impairments

Sponsors & Collaborators

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

Study Sites (22)

Rehabilitationszentrum St. Veit im Pongau

Sankt Veit im Pongau, Salzburg, 5621, Austria

Location

Kepler Universitätsklinikum

Linz, Upper Austria, 4021, Austria

Location

Medical University Graz

Graz, Austria

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

St. Anna Kinderspital

Vienna, 1090, Austria

Location

Universitätsklinikum Frankfurt am Main

Frankfurt am Main, Hesse, 60590, Germany

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

Universitätsklinikum Münster

Münster, North Rhine-Westphalia, 48149, Germany

Location

Universitätsklinikum des Saarlandes

Homburg, Saarland, 66421, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

Location

Klinik Bad Oexen

Bad Oeynhausen, 32549, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, Germany

Location

Luca-Dethlefsen-Hilfe e.V.

Bielefeld, Germany

Location

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Universitätsklinikum Mannheim

Mannheim, Germany

Location

Universitätsklinikum Regensburg

Regensburg, Germany

Location

Universitätsklinikum Tübingen

Tübingen, Germany

Location

Universitätsklinikum Würzburg

Würzburg, Germany

Location

Ospedale di Bolzano

Bolzano, Trentino-Alto Adige, 39100, Italy

Location

Inselspital, Universitätsspital Bern

Bern, Switzerland

Location

Related Publications (9)

• 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.

  PMID: 26700916 BACKGROUND

• 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.

  PMID: 29080381 BACKGROUND

• 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.

  PMID: 29747651 BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 20435702 BACKGROUND

• 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.

  PMID: 21246321 BACKGROUND

• 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.

  PMID: 39538073 DERIVED

• 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.

  PMID: 39107671 DERIVED

MeSH Terms

Conditions

Brain Neoplasms; Neurofibromatoses; Sarcoma; Leukemia; Hematologic Diseases; Neuroblastoma

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neoplasms, Connective and Soft Tissue; Hemic and Lymphatic Diseases; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Coordinator

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: July 17, 2020
• Study Start: September 7, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (5); DE (15); CH (1); IT (1)