Brain TumorNCT04474678
Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!")
A study testing "My Logbook! - I know my way around!" in people with Brain Tumor and Neurofibromatoses, run by Medical University of Vienna at 22 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Brain Tumor, Neurofibromatoses, Sarcoma
- What is being tested?
- "My Logbook! - I know my way around!"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 22 sitesin 4 countries
- Study dates
- 7 Sep 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- non-German speaking
- Major vision impairments
- Major auditive impairments
Trial locations and contacts
22 sites in 4 countries.
22 sites in 4 countries
Germany15 sites
Klinik Bad Oexen
Bad Oeynhausen, 32549
Charité - Universitätsmedizin Berlin
Berlin
Luca-Dethlefsen-Hilfe e.V.
Bielefeld
Universitätsklinikum Carl Gustav Carus Dresden
Dresden
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, 45147
Universitätsklinikum Frankfurt am Main
Frankfurt am Main, Hesse, 60590
Universitätsklinikum Hamburg-Eppendorf
Hamburg
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Universitätsklinikum des Saarlandes
Homburg, Saarland, 66421
Universitätsklinikum Leipzig
Leipzig, Saxony, 04103
Universitätsklinikum Mannheim
Mannheim
Universitätsklinikum Münster
Münster, North Rhine-Westphalia, 48149
Universitätsklinikum Regensburg
Regensburg
Universitätsklinikum Tübingen
Tübingen
Universitätsklinikum Würzburg
Würzburg
Austria5 sites
Medical University Graz
Graz
Kepler Universitätsklinikum
Linz, Upper Austria, 4021
Rehabilitationszentrum St. Veit im Pongau
Sankt Veit im Pongau, State of Salzburg, 5621
Medical University of Vienna
Vienna, 1090
St. Anna Kinderspital
Vienna, 1090
About this study
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.
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.
Read the 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.
- Conditions
- Brain Tumor, Neurofibromatoses, Sarcoma, Leukemia, Hematologic Diseases, Neuroblastoma
- Being tested
- "My Logbook! - I know my way around!"
- Medical subject headings
- Brain Neoplasms, Neurofibromatoses, Sarcoma, Leukemia, Hematologic Diseases, Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"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.
| Study group | Role | What they receive |
|---|---|---|
| All Patients | Other | Since this is a single-group study, all patients are within the same arm Receives: Other: "My Logbook! - I know my way around!" |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
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
Measured: During the first two months from diagnosis or start of psychosocial treatment - up to three Months
Strengths and Difficulties Questionnaire (SDQ; Goodman, 1999)
The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioural screening questionnaire about 3-16 year olds.
Measured: During the first two months from diagnosis or start of psychosocial treatment - up to three Months
KINDLR (Ravens-Sieberer & Bullinger, 2000)
The KINDLR is a standardized questionnaire for the assessment of quality of life in children and adolescents.
Measured: 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)
Questionnaire for the assessment of health competence in children and adolescents
Measured: During the first two months from diagnosis or start of psychosocial treatment - up to three Months
Medical information
Diagnosis, date of diagnosis, pre-existing conditions, secondary conditions, form of treatment/therapy, psychiatric diagnoses, neurological status
Measured: Within the first week of treatment - up to three Months
Demographic data
Age of patient, sex, parents' education, parents' profession, school form, mother language of patient
Measured: During the first two months from diagnosis or start of psychosocial treatment - up to three Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start7 Sep 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- St. Anna Kinderspital, Austria, Charite University, Berlin, Germany, Cnopfsche Kinderklinik, Nürnberg, Kepler University Hospital, University Hospital, Saarland, Hannover Medical School, Krankenhaus Bozen, Goethe University, 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., Insel Gruppe AG, University Hospital Bern, Staedtisches Klinikum Karlsruhe
- Responsible party
- Principal investigator, Dr. Liesa J. Weiler-Wichtl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474678
- Sponsor's protocol ID
- 1564/2017
- Status last verified
- Jan 2024
- First submitted
- 23 Jun 2020
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26700916Scialla 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.
PubMed 29080381Baxter 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.
PubMed 29747651Schurman 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.
PubMed 12778358Stuber 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.
PubMed 20435702Koch 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.
PubMed 21246321Weiler-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.
PubMed 42631525Weiler-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.
PubMed 39538073Weiler-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.
PubMed 39107671
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04474678
- Acronym / sponsor ID
- 1564/2017
- Conditions
- Brain Tumor, Neurofibromatoses, Sarcoma, Leukemia, Hematologic Diseases, Neuroblastoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- St. Anna Kinderspital, Austria, Charite University, Berlin, Germany, Cnopfsche Kinderklinik, Nürnberg, Kepler University Hospital, University Hospital, Saarland, Hannover Medical School, Krankenhaus Bozen, Goethe University, 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., Insel Gruppe AG, University Hospital Bern, Staedtisches Klinikum Karlsruhe
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 17 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Patients | Other | Other: "My Logbook! - I know my way around!"Since this is a single-group study, all patients are within the same arm |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- non-German speaking
- Major vision impairments
- Major auditive impairments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "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. | Other | All Patients |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
6 secondary outcomes
Intelligence test
Time frame: During the first two months from diagnosis or start of psychosocial treatment - up to three Months
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
KINDLR (Ravens-Sieberer & Bullinger, 2000)
Time frame: 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)
Time frame: During the first two months from diagnosis or start of psychosocial treatment - up to three Months
Medical information
Time frame: Within the first week of treatment - up to three Months
Demographic data
Time frame: During the first two months from diagnosis or start of psychosocial treatment - up to three Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Background: PubMed 26700916Kazak 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.
- Background: PubMed 29080381Scialla 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.
- Background: PubMed 29747651Baxter 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.
- BackgroundSchurman 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: PubMed 12778358Schreiber-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.
- Background: PubMed 20435702Stuber 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.
- Background: PubMed 21246321Koch 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.
- Derived from this study: PubMed 42631525Weiler-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.
- Derived from this study: PubMed 39538073Weiler-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.
- Derived from this study: PubMed 39107671Weiler-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.
- Individual participant dataSharing planned: No
Related trials for Brain Tumor
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "My Logbook! - I know my way around!" in people with Brain Tumor and Neurofibromatoses, run by Medical University of Vienna at 22 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Germany, Austria, Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04474678, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.