Clinical trial NCT05245123: Psychosocial Situation of Children With Rare Solid Abdominal Tumors and Their Families
Official title: Psychosocial Situation of Children With Rare Solid Abdominal Tumors and Their Families
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroblastoma
Nephroblastoma
Hepatoblastoma
Keywords: rare diseases
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical study participants for the diagnostic study are patients who have sought treatment at the University Medical Center Hamburg-Eppendorf and University Medical Center Mannheim due to a rare pediatric disease. 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 at the University Medical Center Hamburg-Eppendorfin and University Medical Center Mannheim the first 3 years of life that does not cause chronic complaints; such as hernia surgery or testicular relocation.

Brief summary: 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.

Detailed description: The central objective of the cross-sectional study is to show the psychosocial supply gap for families with children and adolescents affected by rare diseases in the field of oncology pediatric surgery. Among the rare diseases that are included are rare solid abdominal tumors. In order to have a comparative sample, additional data of a matched control group are collected. Central standardized psychosocial outcomes will be assessed from the perspectives of the parents and the affected child.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of Life of the parents (EQ-5D)
timeFrame: 1 minutes
measure: Health-related Quality of Life of the parents (SF-12)
timeFrame: 4 minutes
measure: Severity of depression (PHQ-9)
timeFrame: 2 minutes
measure: Severity of generalized anxiety disorder
timeFrame: 1 minutes
measure: Mental health of the parents (BSI-18)
timeFrame: 4 minutes
measure: Health-related quality of life of the chronically-ill children/adolescents (Peds-QL 4.0)
timeFrame: 4 minutes
measure: Psychiatric disorders of the chronically-ill children/adolescents (SDQ)
timeFrame: 4 minutes
Secondary outcomes:
measure: Social support of the parents, of the chronically-ill children/adolescents (OSSS)
timeFrame: 3 minutes
measure: Coping of the parents (CHIP-D)
timeFrame: 3 minutes
measure: Family relationships, family dynamics and functionality (FB-A)
timeFrame: 3 minutes
measure: Familial predispositions (FaBel)
timeFrame: 3 minutes
measure: Satisfaction with the relationship and parenting relationship of the parents (PFB)
timeFrame: 4 minutes
measure: Parent-child communication (PACS)
timeFrame: 4 minutes
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: University Medical Center Mannheim
state: Baden-Württemberg
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
References: