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Comprehensive support for families with parental cancer (Family-SCOUT), evaluation of a complex intervention: study protocol for a non-randomized controlled trial.
Dohmen, Marc; Petermann-Meyer, Andrea; Blei, Daniel; Bremen, Rebecca; Brock-Midding, Evamarie; Brüne, Manuela; Geiser, Franziska; Haastert, Burkhard; Halbach, Sarah Maria; Heuser, Christian; Holsteg, Steffen; Heier, Lina; Icks, Andrea; Karger, Andre; Montalbo, Joseph; Nakata, Hannah; Panse, Jens; Rottmann, Till-Philip; Sättler, Kristina; Viehmann, Anja; Vomhof, Markus; Ernstmann, Nicole; Brümmendorf, Tim H.
Afiliación
  • Dohmen M; Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Faculty of Medicine, RWTH Aachen University, Aachen, Germany.
  • Petermann-Meyer A; Center for Integrated Oncology, Aachen Bonn Cologne Duesseldorf (CIO ABCD), Germany.
  • Blei D; Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Faculty of Medicine, RWTH Aachen University, Aachen, Germany. apetermann-meyer@ukaachen.de.
  • Bremen R; Center for Integrated Oncology, Aachen Bonn Cologne Duesseldorf (CIO ABCD), Germany. apetermann-meyer@ukaachen.de.
  • Brock-Midding E; Center for Integrated Oncology, Aachen Bonn Cologne Duesseldorf (CIO ABCD), Germany.
  • Brüne M; Department of Psychosomatic Medicine and Psychotherapy, University Hospital Bonn, Bonn, Germany.
  • Geiser F; Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, Faculty of Medicine, RWTH Aachen University, Aachen, Germany.
  • Haastert B; Center for Integrated Oncology, Aachen Bonn Cologne Duesseldorf (CIO ABCD), Germany.
  • Halbach SM; Center for Integrated Oncology, Aachen Bonn Cologne Duesseldorf (CIO ABCD), Germany.
  • Heuser C; Center for Health Communication and Health Services Research, Department of Psychosomatic Medicine and Psychotherapy, University Hospital Bonn, Bonn, Germany.
  • Holsteg S; Institute for Health Services Research and Health Economics, Center for Health and Society, Faculty of Medicine, Heinrich Heine University Düsseldorf, Duesseldorf, Germany.
  • Heier L; Center for Integrated Oncology, Aachen Bonn Cologne Duesseldorf (CIO ABCD), Germany.
  • Icks A; Department of Psychosomatic Medicine and Psychotherapy, University Hospital Bonn, Bonn, Germany.
  • Karger A; Institute for Health Services Research and Health Economics, Center for Health and Society, Faculty of Medicine, Heinrich Heine University Düsseldorf, Duesseldorf, Germany.
  • Montalbo J; mediStatistica, Neuenrade, Germany.
  • Nakata H; Center for Integrated Oncology, Aachen Bonn Cologne Duesseldorf (CIO ABCD), Germany.
  • Panse J; Center for Health Communication and Health Services Research, Department of Psychosomatic Medicine and Psychotherapy, University Hospital Bonn, Bonn, Germany.
  • Rottmann TP; Center for Integrated Oncology, Aachen Bonn Cologne Duesseldorf (CIO ABCD), Germany.
  • Sättler K; Center for Health Communication and Health Services Research, Department of Psychosomatic Medicine and Psychotherapy, University Hospital Bonn, Bonn, Germany.
  • Viehmann A; Center for Integrated Oncology, Aachen Bonn Cologne Duesseldorf (CIO ABCD), Germany.
  • Vomhof M; Clinical Institute of Psychosomatic Medicine and Psychotherapy, Faculty of Medicine, University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Duesseldorf, Germany.
  • Ernstmann N; Center for Integrated Oncology, Aachen Bonn Cologne Duesseldorf (CIO ABCD), Germany.
  • Brümmendorf TH; Center for Health Communication and Health Services Research, Department of Psychosomatic Medicine and Psychotherapy, University Hospital Bonn, Bonn, Germany.
Trials ; 22(1): 622, 2021 Sep 15.
Article en En | MEDLINE | ID: mdl-34526078
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Padres / Neoplasias Tipo de estudio: Clinical_trials / Diagnostic_studies / Prognostic_studies / Qualitative_research Límite: Child / Humans País/Región como asunto: Europa Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2021 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Reino Unido

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Padres / Neoplasias Tipo de estudio: Clinical_trials / Diagnostic_studies / Prognostic_studies / Qualitative_research Límite: Child / Humans País/Región como asunto: Europa Idioma: En Revista: Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2021 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Reino Unido