Psychosocial Situation of Children With Rare Solid Abdominal Tumors and Their Families

Universitätsklinikum Hamburg-Eppendorf100 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Neuroblastoma Nephroblastoma Hepatoblastoma

Eligibility

Sex: ALLMin age: 1 MonthMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (2)

University Medical Center Mannheim

Mannheim, Baden-Wurttemberg, Germany

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Outcomes

Primary Outcomes

Quality of Life of the parents (EQ-5D)

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.

Time frame: 1 minutes

Health-related Quality of Life of the parents (SF-12)

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.

Time frame: 4 minutes

Severity of depression (PHQ-9)

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.

Time frame: 2 minutes

Severity of generalized anxiety disorder

Generalizied Anxiety Disorder Scale-7 (GAD-7; Spitzer, Kroenke \& Löwe, 2006). The instrument consists of 7 items. Higher score indicate greater anxiety levels.

Time frame: 1 minutes

Mental health of the parents (BSI-18)

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.

Time frame: 4 minutes

Health-related quality of life of the chronically-ill children/adolescents (Peds-QL 4.0)

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.

Data from ClinicalTrials.gov

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Secondary Outcomes

Social support of the parents, of the chronically-ill children/adolescents (OSSS)

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

Time frame: 3 minutes

Coping of the parents (CHIP-D)

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.

Time frame: 3 minutes

Family relationships, family dynamics and functionality (FB-A)

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)

Time frame: 3 minutes

Familial predispositions (FaBel)

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).

Time frame: 3 minutes

Satisfaction with the relationship and parenting relationship of the parents (PFB)

Satisfaction with the relationship and parenting relationship of the parents, assessed from the perspective of the parents by the "Partnerschaftsfragebogen" (PFB; Hahlweg, 2016).

Time frame: 4 minutes

Parent-child communication (PACS)

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.

Time frame: 4 minutes