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Clinical Trials/NCT04186923
NCT04186923
Completed
Not Applicable

Familien-SCOUT: Comprehensive Support for Families With a Parent Suffering From Cancer

RWTH Aachen University3 sites in 1 country472 target enrollmentOctober 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Families With Minor Children and One Parent Suffering From Cancer
Sponsor
RWTH Aachen University
Enrollment
472
Locations
3
Primary Endpoint
Hospital Anxiety and Depression Scale (HADS
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

When a parent with minor children falls ill with cancer, it is extremely stressful for all of the family members, including the partner and children. Familiar everyday routines are often disrupted even at an early stage, and for a prolonged period. Financial difficulties, the threat represented by the uncertain course of the disease, and worries about the children's future have a cumulative effect. The affected families are thereby pushed to their limits organizationally and emotionally. The burden involved tends to be underestimated, and secondary psychological conditions often develop among all the family members. They often do not have adequate access to support.

The aim of this project is to establish a care management system that provides support for families with underage children in which one parent is seriously ill. In order to reduce the burden on families, "family SCOUTS" are to be used who can provide advice and information at an early stage. They are intended to encourage families to discuss things openly, and they should also facilitate access to all the support services available.

The project will evaluate whether the use of family SCOUTS reduces the burden on the family in comparison with families who do not have a family SCOUT. For this purpose, investigations will be carried out before and after the family SCOUTS are deployed. Standardized questionnaires, interviews, and routine data from the participating health-insurance companies will provide the basic data.

Registry
clinicaltrials.gov
Start Date
October 1, 2019
End Date
June 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Confirmed ICD diagnosis of cancer in one parent
  • Custody of at least one underage child
  • Adequate knowledge of German
  • Availability of informed consent to participate in the study from the patient and/or healthy parent and linkage to questionnaire data and routine data

Exclusion Criteria

  • Withdrawal of consent by the ill or healthy parent
  • Relevant cognitive limitation, advanced dementia
  • Individuals who are in relationships of dependence or employment to the project managers or their representatives

Outcomes

Primary Outcomes

Hospital Anxiety and Depression Scale (HADS

Time Frame: Change from Baseline HADS at 9 months

HADS is used to record anxiety and depression in patients with physical diseases or psychogenic physical symptoms.Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. The HADS uses a scale and therefore the data returned from the HADS is ordinal.

Secondary Outcomes

  • Parenting Concerns Questionnaire (PCQ)(baseline and 9 month)
  • Distress Thermometer (DT)(baseline & 9 month)
  • HLS-EU-Q16(3 month)
  • PA-F-P-KF(baseline & 9 month)
  • CaPIN(3 & 9 Month)
  • MOS-SS(3 month)
  • FAD(baseline & 9 month)
  • EQ-5D-5L(baseline, 3 & 9 month)
  • KIDSCREEN-10:(baseline & 9 month)

Study Sites (3)

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