Hepatoblastoma, Nephroblastoma, Neuroblastoma
Conditions
Keywords
rare diseases
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.
Interventions
None listed
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
1 Months to 17 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychiatric disorders of the chronically-ill children/adolescents (SDQ) | 4 minutes | Psychiatric disorders of the chronically-ill children/adolescents assessed perspective of the child/adolescent and from the perspective of the parents by the Strengths and Difficulties Questionnaire (SDQ; Klasen, Woerner, Rothenberger, & Goodman, 2003). Items are rated on a three-point Likert scale (0 to 2). Higher scores represent greater psychopathology or greater prosocial behavior. |
| Severity of generalized anxiety disorder | 1 minutes | Generalizied Anxiety Disorder Scale-7 (GAD-7; Spitzer, Kroenke & Löwe, 2006). The instrument consists of 7 items. Higher score indicate greater anxiety levels. |
| Quality of Life of the parents (EQ-5D) | 1 minutes | 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. |
| Health-related Quality of Life of the parents (SF-12) | 4 minutes | Health-related Quality of Life (HRQoL) of the parents, assessed from the perspective of the parents by the Short-Form-12 (SF-12; Morfeld, Kirchberger & Bullinger, 2011). The instrument consists of 12 items. Higher scores indicate greater HRQoL. |
| Severity of depression (PHQ-9) | 2 minutes | Severity of depression, will be assessed with the 9-question Patient Health Questionnaire (PHQ-9; Löwe et al., 2015). The instrument consists of 9 items. Higher scores indicate greater depression levels. |
| Mental health of the parents (BSI-18) | 4 minutes | Mental health of the parents, assessed from the perspective of the parents by the Brief Symptom Inventory-18 (BSI-18; Spitzer et al., 2011). The instrument consists of 18 items, which are answered on a five-point Likert scale (0 to 4). Higher BSI scores indicate greater psychological distress. |
| Health-related quality of life of the chronically-ill children/adolescents (Peds-QL 4.0) | 4 minutes | Health-related quality of life of the chronically-ill children/adolescents, assessed from the perspective of the child/adolescent (from 10 years of age) and from the perspective of the parents by the Pediatric Quality of Life Inventory 4.0 (Peds-QL 4.0; (Varni, Seid, & Kurtin, 2001). Items will be linearly transformed to a scale of 0 to 100, with higher scores indicating better HRQoL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coping of the parents (CHIP-D) | 3 minutes | Coping of the parents, assessed from the perspective of the parents by the German version of the Coping Health Inventory for Parents (CHIP-D; McCubbin, McCubbin, Cauble & Goldbeck, 2001). Items are rated on a four-point Likert scale (0 to 3). Higher scores represent greater use of the respective coping pattern. |
| Family relationships, family dynamics and functionality (FB-A) | 3 minutes | Family relationships, family dynamics and functionality, assessed from the perspective of the parents, of the chronically-ill children/adolescents and from the sibling, respectively by Familienbögen (FB-A; Cierpka & Frevert, 1994). Items are rated on a four-point Likert scale (0 to 3) |
| Familial predispositions (FaBel) | 3 minutes | familial predispositions assessed from the perspective of the parents by the Familien-Belastungs-Fragebogen (FaBel; Ravens-Sieberer, 2001). Items are rated on a four-point Likert scale ranging from 1 (is not right at all) to 4 (is completely right). |
| Satisfaction with the relationship and parenting relationship of the parents (PFB) | 4 minutes | Satisfaction with the relationship and parenting relationship of the parents, assessed from the perspective of the parents by the Partnerschaftsfragebogen (PFB; Hahlweg, 2016). |
| Parent-child communication (PACS) | 4 minutes | Parent-child communication was assessed from the perspective of the child/adolescent and from the perspective of the parents by the Parent-Adolescent Communication Scale (PACS; Barnes & Olsen, 1982). Items are rated on a five-point Likert scale. |
| Social support of the parents, of the chronically-ill children/adolescents (OSSS) | 3 minutes | Social support of the parents, of the chronically-ill children/adolescents and of the siblings, assessed from the perspective of the parents, of the chronically-ill children/adolescents and from the sibling, respectively, by the Oslo Social Support Scale (OSSS; Dalgard, 2006). The sum score ranges from 3 to 14. The higher the sum score, the stronger the social support |
Countries
Germany
Outcome results
None listed