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

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ClinicalTrials.gov Identifier: NCT04474678
Recruitment Status : Recruiting
First Posted : July 17, 2020
Last Update Posted : November 14, 2022
Sponsor:
Collaborators:
St. Anna Kinderspital, Austria
Charite University, Berlin, Germany
Cnopfsche Kinderklinik, Nürnberg
Kepler University Hospital
University Hospital, Saarland
Hannover Medical School
Krankenhaus Bozen
University Hospital Frankfurt
Universitätsklinikum Hamburg-Eppendorf
Universitätsklinikum Leipzig
University Hospital Muenster
University Hospital Tuebingen
Salzburger Landeskliniken
Leuwaldhof St.Veit (Kinder- und Jugendreha)
University Hospital, Essen
Medical University of Graz
University Hospital Erlangen
Wuerzburg University Hospital
Klinik Bad Oexen, Germany
Universitätsklinikum Köln
University Hospital Schleswig-Holstein
University Hospital Carl Gustav Carus
Universitätsmedizin Mannheim
University Hospital Regensburg
Luca-Dethlefsen-Hilfe e.V.
University Hospital Inselspital, Berne
Staedtisches Klinikum Karlsruhe
Information provided by (Responsible Party):
Dr. Liesa J. Weiler-Wichtl, Medical University of Vienna

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.

Condition or disease Intervention/treatment Phase
Brain Tumor Neurofibromatoses Sarcoma Leukemia Hematologic Diseases Neuroblastoma Other: "My Logbook! - I know my way around!" Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : September 7, 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Emotional well-being, T1 [ Time Frame: 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 ]
    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.

  2. Emotional well-being, T2 [ Time Frame: Post to first session of the special issue (booklet) - through study completion or end of medical treatment, an average of 1 year ]
    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.

  3. Emotional well-being, T3 [ Time Frame: 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 ]
    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.

  4. Emotional well-being, T4 [ Time Frame: During, post to second session of the special issue (booklet) - through study completion or end of medical treatment, an average of 1 year ]
    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.

  5. Emotional well-being, T5 [ Time Frame: During, but before completion of treatment - through study completion or end of medical treatment, an average of 1 year ]
    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.

  6. Knowledgeability, T1 [ Time Frame: 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 ]
    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.

  7. Knowledgeability, T2 [ Time Frame: Post to first session of the special issue (booklet) - through study completion or end of medical treatment, an average of 1 year ]
    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.

  8. Knowledgeability, T3 [ Time Frame: 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 ]
    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.

  9. Knowledgeability, T4 [ Time Frame: During, post to second session of the special issue (booklet) - through study completion or end of medical treatment, an average of 1 year ]
    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.

  10. Knowledgeability, T5 [ Time Frame: During, but before completion of treatment - through study completion or end of medical treatment, an average of 1 year ]
    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.

  11. Feasibility of program [ Time Frame: 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 ]
    Rating of feasibility of the program by medical staff


Secondary Outcome Measures :
  1. Intelligence test [ Time Frame: During the first two months from diagnosis or start of psychosocial treatment - up to three Months ]

    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


  2. Strengths and Difficulties Questionnaire (SDQ; Goodman, 1999) [ Time Frame: During the first two months from diagnosis or start of psychosocial treatment - up to three Months ]
    The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioural screening questionnaire about 3-16 year olds.

  3. KINDLR (Ravens-Sieberer & Bullinger, 2000) [ Time Frame: During the first two months from diagnosis or start of psychosocial treatment - up to three Months ]
    The KINDLR is a standardized questionnaire for the assessment of quality of life in children and adolescents.

  4. Questionnaire on Health Competence in Children and Adolescents, (Weiler, Fohn, Pletschko, Schwarzinger, & Leiss, 2017) [ Time Frame: During the first two months from diagnosis or start of psychosocial treatment - up to three Months ]
    Questionnaire for the assessment of health competence in children and adolescents

  5. Medical information [ Time Frame: Within the first week of treatment - up to three Months ]
    Diagnosis, date of diagnosis, pre-existing conditions, secondary conditions, form of treatment/therapy, psychiatric diagnoses, neurological status

  6. Demographic data [ Time Frame: During the first two months from diagnosis or start of psychosocial treatment - up to three Months ]
    Age of patient, sex, parents' education, parents' profession, school form, mother language of patient



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04474678


Contacts
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Contact: Liesa Weiler-Wichtl, Dr. +43140400 ext 34200 liesa.weiler@meduniwien.ac.at

Locations
Show Show 28 study locations
Sponsors and Collaborators
Medical University of Vienna
St. Anna Kinderspital, Austria
Charite University, Berlin, Germany
Cnopfsche Kinderklinik, Nürnberg
Kepler University Hospital
University Hospital, Saarland
Hannover Medical School
Krankenhaus Bozen
University Hospital Frankfurt
Universitätsklinikum Hamburg-Eppendorf
Universitätsklinikum Leipzig
University Hospital Muenster
University Hospital Tuebingen
Salzburger Landeskliniken
Leuwaldhof St.Veit (Kinder- und Jugendreha)
University Hospital, Essen
Medical University of Graz
University Hospital Erlangen
Wuerzburg University Hospital
Klinik Bad Oexen, Germany
Universitätsklinikum Köln
University Hospital Schleswig-Holstein
University Hospital Carl Gustav Carus
Universitätsmedizin Mannheim
University Hospital Regensburg
Luca-Dethlefsen-Hilfe e.V.
University Hospital Inselspital, Berne
Staedtisches Klinikum Karlsruhe
Publications:
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.

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Responsible Party: Dr. Liesa J. Weiler-Wichtl, Project Coordinator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT04474678    
Other Study ID Numbers: 1564/2017
First Posted: July 17, 2020    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroblastoma
Neurofibromatoses
Neurofibromatosis 1
Neurofibroma
Hematologic Diseases
Neoplasms by Histologic Type
Neoplasms
Nervous System Neoplasms
Nervous System Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Nerve Sheath Neoplasms
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Neoplasms