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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT04474678

Studienbeginn:
September 2020

Letztes Update:
02.09.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Neurofibromatoses, Neurofibromatosis 1, Neurofibroma, Neuroblastoma, Hematologic Diseases

Geschlecht:
Alle

Altersgruppe:
Kinder (0-17)

Phase:
-

Sponsor:
Medical University of Vienna

Collaborator:
St. Anna Kinderspital, Austria, Charite University, Berlin, Germany, Cnopfsche Kinderklinik, Nürnberg, Dr. von Haunersches Children's Medical Hospital, University of Munich, Germany, Kepler University Hospital, University Hospital, Saarland, Hannover Medical Sc

Kontakt

Liesa Weiler-Wichtl, Dr.
Kontakt:
Phone: +43140400
Phone (ext.): 34200
E-Mail: liesa.weiler@meduniwien.ac.at
» Kontaktdaten anzeigen

Studienlocations
(3 von 15)

Dr. von Haunersches Kinderspital
80337 München
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Alexandra Nest, Dipl.-Psych.
Phone: +498976736820
E-Mail: alexandra.nest@med.uni-muenchen.de
» Ansprechpartner anzeigen
Universitätsklinikum Frankfurt am Main
60590 Frankfurt am Main
(Hessen)
GermanyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Sandra Lange, Dipl.-Psych.
Phone: +496963016073
E-Mail: Sandra.Lange@kgu.de
» Ansprechpartner anzeigen
Leberkrebszentrum Medizinische Hochschule Hannover
Carl-Neuberg-Straße 1
30625 Hannover
DeutschlandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Anne Paduch, MSc.
Phone: +49511532 9063
E-Mail: Paduch.Anne@mh-hannover.de
» Ansprechpartner anzeigen
Kinderonkologisches Zentrum Universitätsklinikum Essen
Hufelandstraße 55
45147 Essen
DeutschlandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Andreas Wiener, Dr.
Phone: +49 201 723 6600
E-Mail: andreas.wiener@uk-essen.de
» Ansprechpartner anzeigen
Kinderonkologisches Zentrum am Universitätsklinikum Münster
Albert-Schweitzer-Campus 1
48149 Münster
DeutschlandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Nicole Salzmann, Dipl.-Psych.
Phone: +492518343402
E-Mail: Nicole.Salzmann@ukmuenster.de
» Ansprechpartner anzeigen
Universitäts-Brustzentrum am Universitätsklinikum des Saarlandes
Kirrberger Straße 100
66424 Homburg
DeutschlandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Iris Lein-Köhler, Dipl.-Psych.
Phone: +4968411628406
E-Mail: iris.lein-koehler@uks.eu
» Ansprechpartner anzeigen
Gynäkologisches Tumorzentrum am Universitätsklinikum Leipzig
4103 Leipzig
DeutschlandNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Florian Schepper, Dr.
Phone: +491636334776
E-Mail: florian.schepper@medizin.uni-leipzig.de
» Ansprechpartner anzeigen
Rehabilitationszentrum St. Veit im Pongau
5621 St. Veit
AustriaNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Martina Geihseder-Zach, Mag.
Phone: +436415
Phone (ext.): 50300
E-Mail: martina.geihseder-zach@reha-stveit.at
» Ansprechpartner anzeigen
St. Anna Kinderspital
1090 Vienna
AustriaNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Stephanie Kirschner, Mag.
Phone: +43140170
Phone (ext.): 26859336
E-Mail: stephanie.kirschner@stanna.at
» Ansprechpartner anzeigen
Ospedale di Bolzano
39100 Bolzano
ItalyNoch nicht rekrutierend» Google-Maps
Ansprechpartner:
Barbara Schönthaler
Phone: +39471909796
E-Mail: barbara.schönthaler@sabes.it

Martina Kosta
E-Mail: martina.kosta@rolmail.net
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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:

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

Geprüfte Regime

  • "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.

Quelle: ClinicalTrials.gov


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