Familien-SCOUT: Comprehensive Support for Families With a Parent Suffering From Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- RWTH Aachen University
- Enrollment
- 472
- Locations
- 3
- Primary Endpoint
- Hospital Anxiety and Depression Scale (HADS
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Intervention group (IG)
Families receive permanent contact persons to support in the organisation of everyday life, financial applications, during emotional coping with illness and open communication within the family.
Intervention: F-SPOKE (Other)
Control Group
In the control group the families are treated according to the standard of care.
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
- CaPIN(3 & 9 Month)
- 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)
- MOS-SS(3 month)
- FAD(baseline & 9 month)
- EQ-5D-5L(baseline, 3 & 9 month)
- KIDSCREEN-10:(baseline & 9 month)