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

NCT ID: NCT04186923

Last Updated: 2022-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

472 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2022-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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Families With Minor Children and One Parent Suffering From Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

F-SPOKE

Intervention Type OTHER

This project includes communicative, emotional, and also organizational support with outreach across different sectors and phases (F-SPOKE - family-centered, cross-sector and cross-phase organizational, communicative, and emotional support).

Control Group

In the control group the families are treated according to the standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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F-SPOKE

This project includes communicative, emotional, and also organizational support with outreach across different sectors and phases (F-SPOKE - family-centered, cross-sector and cross-phase organizational, communicative, and emotional support).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tim H. Brümmendorf, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Hematology, Oncology, Hemostaseology, RWTH Aachen University

Locations

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Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Faculty of Medicine, RWTH Aachen University

Aachen, , Germany

Site Status

Department of Psychosomatic Medicine and Psychotherapy, University Hospital Bonn

Bonn, , Germany

Site Status

Clinical Institute of Psychosomatic Medicine and Psychotherapy, Heinrich-Heine-University Duesseldorf

Düsseldorf, , Germany

Site Status

Countries

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Germany

References

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Holsteg S, Klett MK, Kisic AM, Horbach-Bremen R, Brune M, Dohmen M, Drueke B, Ernstmann N, Geiser F, Heier L, Heuser C, Icks A, Panse J, Petermann-Meyer A, Viehmann A, Karger A. Psychological burden, quality of life, problems, and parental concerns of single mothers with cancer: a cross-sectional comparison. Support Care Cancer. 2025 Feb 11;33(3):173. doi: 10.1007/s00520-025-09225-y.

Reference Type DERIVED
PMID: 39932595 (View on PubMed)

Ernstmann N, Nakata H, Heier L, Heuser C, Dohmen M, Bremen R, Geiser F, Holsteg S, Karger A, Viehmann A, Brune M, Icks A, Haastert B, Brummendorf TH, Petermann-Meyer A. Feasibility of a complex psychosocial intervention for families with parental cancer: acceptability, suitability, implementability, and perceived support. J Cancer Res Clin Oncol. 2024 Oct 17;150(10):464. doi: 10.1007/s00432-024-05946-5.

Reference Type DERIVED
PMID: 39414623 (View on PubMed)

Heuser C, Schneider JN, Heier L, Ernstmann N, Nakata H, Petermann-Meyer A, Bremen R, Karger A, Icks A, Brummendorf TH, Geiser F. Family resilience of families with parental cancer and minor children: a qualitative analysis. Front Psychol. 2024 Jan 19;14:1251049. doi: 10.3389/fpsyg.2023.1251049. eCollection 2023.

Reference Type DERIVED
PMID: 38314254 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34526078 (View on PubMed)

Other Identifiers

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18-033

Identifier Type: -

Identifier Source: org_study_id

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