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

NCT ID: NCT05245123

Last Updated: 2024-06-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-21
• Study Completion Date: 2023-03-31

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.

Conditions

Neuroblastoma; Nephroblastoma; Hepatoblastoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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.

• Families of children with a congenital or chronic disease.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Johannes Boettcher

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Medical Center Mannheim

Mannheim, Baden-Wurttemberg, Germany

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Countries

Germany

Other Identifiers

2021-100605-BO-ff

Identifier Type: -

Identifier Source: org_study_id