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

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.

Study Overview

• Status: Recruiting
• Conditions: Neuroblastoma; Hepatoblastoma; Nephroblastoma

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.

• Study Type: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

• Study Contact: Name: Johannes Boettcher; Phone Number: +49 (0) 40 7410 - 24155; Email: j.boettcher@uke.de
• Study Contact Backup: Name: Michael Boettcher, Prof. Dr.; Email: michael.boettcher@umm.de

Study Locations

• Germany
  • Hamburg, Germany, 20251
    • Recruiting
    • University Medical Center Hamburg-Eppendorf
    • Contact: Johannes Boettcher; Email: j.boettcher@uke.de
  • Baden-Württemberg
    • Mannheim, Baden-Württemberg, Germany, 68167
      • Not yet recruiting
      • University Medical Center Mannheim
      • Contact: Michael Boettcher, Prof. Dr.; Phone Number: 0621/383-5574; Email: michael.boettcher@umm.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 17 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Families of rare diseased children; 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.
Families in the comparative control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 minutes
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.	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.	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.	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.	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.	4 minutes
Psychiatric disorders of the chronically-ill children/adolescents (SDQ)	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.	4 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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).	3 minutes
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	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).	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.	4 minutes

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: February 20, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: rare diseases
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Neoplasms, Glandular and Epithelial; Genetic Diseases, Inborn; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Kidney Neoplasms; Neoplastic Syndromes, Hereditary; Neoplasms, Complex and Mixed; Neuroectodermal Tumors, Primitive; Neuroectodermal Tumors, Primitive, Peripheral; Abdominal Neoplasms; Neuroblastoma; Wilms Tumor; Hepatoblastoma
• Other Study ID Numbers: 2021-100605-BO-ff

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No