Clinical trial · Observational
Psychosocial Situation of Children With Rare Solid Abdominal Tumors and Their Families
NCT05245123CI-TRIAL-00077884PsyRareCarecompletedClinicalTrials.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)
Families of children with rare diseases (i.e., not more than 5 out of 10.000 people are affected) are often highly burdened with fears, insecurities and concerns regarding the affected child and his/her siblings. The aim of the present research project is to examine the psychosocial burden of the children with rare solid abdominal tumors and their family in order to draw attention to a possible psychosocial care gap in this population.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatoblastoma | Hepatoblastoma | ONTOLOGY_EXACT | 0.98 |
| Nephroblastoma | Wilms Tumor | CURATED_BROADER | 0.80 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Families of rare diseased children
- description
- Clinical study participants are patients who have sought treatment at the University Medical Center Hamburg-Eppendorf and University Medical Centre Mannheim due to the rare disease. Every family receives a comprehensive psychosocial diagnostic in the form of standardized instruments.
- label
- Families in the comparative control group
- description
- Participants in the healthy control sample are matched to the clinical sample in terms of age and gender. Included are families of children aged 0-17 years, who have undergone a surgical procedure in the first 3 years of life that does not cause chronic complaints; such as hernia surgery or testicular relocation.
Primary outcomes (7)
- measure
- Quality of Life of the parents (EQ-5D)
- timeFrame
- 1 minutes
- description
- Quality of Life (QoL) of the parents, assessed from the perspective of the parents by the instrument "European Quality of Life Five Dimension" (EQ-5D; Hinz et al., 2006). The instrument consists of 5 dimensions, which are answered on a three-point scale. Higher scores indicate greater QoL.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria (families of rare disease): * Family with at least one child between 0 and 17 years with rare solid abdominal tumors. * Consent to participate in the study. * Sufficient knowledge of the German language of parents and children. Exclusion Criteria (families of rare disease): \- Severe acute physical, mental and/or cognitive impairment of the child, so that the questionnaire survey does not appear possible and/or unreasonable at this stage. Inclusion Criteria (control group): * Family with at least one child between 0 and 17 years who have undergone a surgical procedure in the first 3 years of life that does not cause chronic complaints * Consent to participate in the study. * Sufficient knowledge of the German language of parents and children. Exclusion Criteria (control group): \- Families of children with a congenital or chronic disease.
References
Publications (0)
Data not yet available
No reference posted for this study.