Comprehensive support for families with parental cancer (Family-SCOUT), evaluation of a complex intervention: study protocol for a non-randomized controlled trial

Marc Dohmen, Andrea Petermann-Meyer, Daniel Blei, Rebecca Bremen, Evamarie Brock-Midding, Manuela Brüne, Franziska Geiser, Burkhard Haastert, Sarah Maria Halbach, Christian Heuser, Steffen Holsteg, Lina Heier, Andrea Icks, Andre Karger, Joseph Montalbo, Hannah Nakata, Jens Panse, Till-Philip Rottmann, Kristina Sättler, Anja Viehmann, Markus Vomhof, Nicole Ernstmann, Tim H Brümmendorf, Marc Dohmen, Andrea Petermann-Meyer, Daniel Blei, Rebecca Bremen, Evamarie Brock-Midding, Manuela Brüne, Franziska Geiser, Burkhard Haastert, Sarah Maria Halbach, Christian Heuser, Steffen Holsteg, Lina Heier, Andrea Icks, Andre Karger, Joseph Montalbo, Hannah Nakata, Jens Panse, Till-Philip Rottmann, Kristina Sättler, Anja Viehmann, Markus Vomhof, Nicole Ernstmann, Tim H Brümmendorf

Abstract

Background: Families with minor children affected by parental cancer are at risk of considerable emotional and organizational stress that can severely burden all family members. So far, there has been a lack of comprehensive support services for affected families. The aim of this project is to implement and evaluate a complex psychosocial intervention for these families by providing advice, information, and care on an emotional, psycho-social, and communicative level during and after the cancer experience and across healthcare sectors.

Methods: Family-SCOUT is a project supported by the German Innovation Fund ( https://innovationsfonds.g-ba.de/ ). The evaluation is based on a mixed-methods quasi-experimental design with the intervention and control groups. A standardized postal survey at three measurement points (T0: study enrollment; T1: 3 months of follow-up; T2: 9 months of follow-up), secondary data from the participating health insurance funds, and semi-structured qualitative interviews are used for summative and formative evaluation. The study aim is to include n=560 families. Data will be analyzed according to the intention-to-treat principle. The primary analysis is the comparison of the Hospital Anxiety and Depression Scale (HADS) response rates (minimal important difference (MID) ≥ 1.6 in at least one of the two parents) at T2 between the intervention and control group using Fisher's exact test. The conduct of the study as well as the development and implementation of the intervention will be accompanied by comprehensive study monitoring following the principles of an effectiveness-implementation hybrid study.

Discussion: The results will allow to test the effectiveness and efficiency of the intervention for the target group. The first experience with the implementation of the intervention in model regions will be available. The evaluation results will serve as the basis to assess the need of including the intervention in the catalog of services of the statutory health insurance funds in Germany.

Trial registration: ClinicalTrials.gov , NCT04186923. Retrospectively registered on 4 December 2019.

Keywords: CIOABCD; COSIP (Children of Somatically Ill Parents); Cancer; F-SCOUT; Family intervention; Intervention study; Minor children; Parental cancer; Parents; Study protocol.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Flowchart of participant flow through the trial and allocation of the intervention to the recruitment sites. SHI statutory health insurance, FPI first patient in, LPI last patient in, LPO last patient out
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trails (SPIRIT) table of enrolment, intervention, and assessments

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