Clinical trial NCT04186923: Familien-SCOUT: Comprehensive Support for Families With a Parent Suffering From Cancer
Official title: Familien-SCOUT: Comprehensive Support for Families With a Parent Suffering From Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Families With Minor Children and One Parent Suffering From Cancer
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 472
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS
timeFrame: Change from Baseline HADS at 9 months
Secondary outcomes:
measure: Distress Thermometer (DT)
timeFrame: baseline & 9 month
measure: Parenting Concerns Questionnaire (PCQ)
timeFrame: baseline and 9 month
measure: HLS-EU-Q16
timeFrame: 3 month
measure: PA-F-P-KF
timeFrame: baseline & 9 month
measure: CaPIN
timeFrame: 3 & 9 Month
measure: MOS-SS
timeFrame: 3 month
measure: FAD
timeFrame: baseline & 9 month
measure: EQ-5D-5L
timeFrame: baseline, 3 & 9 month
measure: KIDSCREEN-10:
timeFrame: baseline & 9 month
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Faculty of Medicine, RWTH Aachen University
city: Bonn
country: Germany
facility: Department of Psychosomatic Medicine and Psychotherapy, University Hospital Bonn
city: Duesseldorf
country: Germany
facility: Clinical Institute of Psychosomatic Medicine and Psychotherapy, Heinrich-Heine-University Duesseldorf
Study officials:
affiliation: Department of Hematology, Oncology, Hemostaseology, RWTH Aachen University
name: Tim H. Brümmendorf, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dohmen M, Petermann-Meyer A, Blei D, Bremen R, Brock-Midding E, Brune M, Geiser F, Haastert B, Halbach SM, Heuser C, Holsteg S, Heier L, Icks A, Karger A, Montalbo J, Nakata H, Panse J, Rottmann TP, Sattler K, Viehmann A, Vomhof M, Ernstmann N, Brummendorf TH. Comprehensive support for families with parental cancer (Family-SCOUT), evaluation of a complex intervention: study protocol for a non-randomized controlled trial. Trials. 2021 Sep 15;22(1):622. doi: 10.1186/s13063-021-05577-y.