Clinical trial · Interventional
Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!")
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.
NCT04474678CI-TRIAL-00072857completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Hematologic Diseases | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Neurofibromatoses | — | UNRESOLVED | — |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| "My Logbook! - I know my way around!" | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- All Patients
- description
- Since this is a single-group study, all patients are within the same arm
- interventionNames
- Other: "My Logbook! - I know my way around!"
Primary outcomes (11)
- measure
- Emotional well-being, T1
- timeFrame
- 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
- description
- 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.
- measure
- Emotional well-being, T2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 14 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDKazak 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
- BACKGROUNDScialla 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
- BACKGROUNDBaxter 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
- 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.
- BACKGROUNDSchreiber-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. PMID 12778358
- BACKGROUNDStuber 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
- BACKGROUNDKoch 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.