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

NCT05245123 | Completed

• 1 other identifier: 2021-100605-BO-ff
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Neuroblastoma; Nephroblastoma; Hepatoblastoma

Keywords

rare diseases

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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 Outcomes (6)

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

  3 minutes

• Coping of the parents (CHIP-D)

  3 minutes

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

  3 minutes

• Familial predispositions (FaBel)

  3 minutes

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

  4 minutes

Study Arms (2)

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.

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- 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.
• 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.
• \- Families of children with a congenital or chronic disease.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (2)

University Medical Center Mannheim

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

University Medical Center Hamburg-Eppendorf

Hamburg, 20251, Germany

Location

MeSH Terms

Conditions

Neuroblastoma; Wilms Tumor; Hepatoblastoma; Rare Diseases

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Complex and Mixed; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 17, 2022
• Study Start: February 21, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

DE (2)