IntroductionPatient–provider communication is an important factor influencing the quality of care in oncology. The study examines the comparative effectiveness of a 10-hour interprofessional communication skills training (CST) programme for physicians and nurses in cancer centres.Methods and analysisKommRhein Interpro is a cluster-randomised trial sponsored by the German Cancer Aid (Deutsche Krebshilfe, DKH) and conducted at the cancer centres of the university hospitals of Aachen, Bonn, Cologne and Düsseldorf. Thirty oncology teams of four cancer centres are randomly assigned to three study arms, providing healthcare professionals with either (a) only written information on patient-centred communication or (b) written information plus CST for physicians or (c) written information plus interprofessional CST for physicians and nurses. For summative evaluation, standardised surveys from three measurement points for patients (T0pat: study enrollment; T1pat: after discharge; T2pat: 3 months’ follow-up) and two measurement points for physicians and nurses (T0hcp: before the intervention; T1hcp: after the intervention) are used. N=1320 valid patient cases are needed for data evaluation. The primary endpoint is fear of progression in patients with cancer after discharge. Data will be analysed according to the intention-to-treat principle using a mixed model for repeated measurement. Secondary outcome is the providers’ self-efficacy in patient centeredness. Individual confounders and possible moderating effects of organisational factors will be considered. Secondary analysis will be performed by means of multilevel analysis and structural equation modelling.Ethics and disseminationA vote of approval has been obtained from the ethics committees of the medical faculties of RWTH Aachen University (EK325/20), University of Bonn (391/20), University of Cologne (20–1332) and Heinrich Heine University Düsseldorf (2019–796). Data protection regulations are adhered to for all processed data. The conduct of the study will be monitored. Dissemination strategies include a transfer workshop with cancer teams and distribution of the final study report to participants.Trial registration numberDRKS00022563; DRKS (German Clinical Trials Register).
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.
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 method quasi-experimental design with intervention and control group. A standardized postal survey at three measurement points (T0: study enrollment; T1: 3 months follow-up; T2: 9 months follow-up), secondary data from the participating health insurance funds, and semi-structured qualitative interviews are used for summative and formative evaluation. 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: Results will allow to test the effectiveness and efficiency of the intervention for the target group. First experience with the implementation of the intervention in model regions will be available. The evaluation results will serve as basis to assess the need of including the intervention in the catalogue of services of the statutory health insurance funds in Germany. Trial registration: ClinicalTrials.gov, NCT04186923. Retrospectively registered on 4 December 2019.
Zusammenfassung Ziel der Studie Familien mit einem onkologisch erkrankten Elternteil sind besonderen emotionalen und organisatorischen Belastungen ausgesetzt, unter denen v. a. minderjährige Kinder leiden. Um die Belastung der Familienmitglieder zu reduzieren und einen koordinierten Zugang zu sozialen und logistischen Unterstützungsmöglichkeiten zu schaffen, wurde das Modellprojekt Brückenschlag initiiert. Ziel des vorliegenden Beitrags ist, die Einführung dieses Projektes in Anlehnung an das Inanspruchnahme-Modell von Andersen bezüglich Akzeptanz und Inanspruchnahme zu evaluieren. Methodik In einer querschnittlich angelegten Beobachtungsstudie im Mixed-Methods-Ansatz wurden semi-strukturierte schriftliche Expertenbefragungen (n=10) und die Sekundäranalyse von Routinedaten des Versorgungsmodells (n=171 Familien) kombiniert. Ergebnisse Quantitative Sekundäranalyse: Die teilnehmenden Familien haben 1–7 Kinder (Median (M) 2, Spannweite (S) 6). In 66% der Fälle ist die Mutter erkrankt, in 20% ist das erkrankte Elternteil alleinerziehend. Die familiären Kommunikationsstrukturen werden als „mittelmäßig“ bis „ziemlich offen“ eingeschätzt. Von den insgesamt 171 Kontaktaufnahmen (Studienzeitraum 9/14 bis 11/17), wurde Brückenschlag von 133 Familien in Anspruch genommen. 59,2% der Kontakte entstanden über die Psychoonkologie und den Sozialdienst. Kam der Kontakt auf Initiative des Patienten selbst oder durch die Psychoonkologie zustande, so wird signifikant häufiger (p=0,047) eine Begleitung etabliert als bei anderen Kontaktpersonen. Qualitative Analyse: Es zeigt sich ein Mangel in der Bekanntschaft und Koordination vorhandener Unterstützungsangebote und an familiären Ressourcen, vorhandene Unterstützungsangebote in Anspruch zu nehmen. Sowohl von den Familien gewünschte als auch im Verlauf etablierte Unterstützung fallen vor allem in den Bereich organisatorischer Unterstützung. Brückenschlag erleichtert dabei die Netzwerkarbeit und übernimmt eine Lotsenfunktion für die Familien. Schlussfolgerung Die gesammelten Daten deuten darauf hin, dass Familien, die in ihren soziodemographischen Merkmalen dem deutschen Durchschnitt entsprechen, tatsächlich einen großen Bedarf an organisatorischer Unterstützung entwickeln, sobald ein Elternteil an Krebs erkrankt. Das Modellprojekt Brückenschlag schafft einen Zugang zu Unterstützungsleistungen für Familien mit einem krebserkrankten Elternteil.
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