Nurse-led care model to overcome migration-related language barriers in people with cancer ( IntVeM ): study protocol for a controlled before-and-after study, process and economic evaluation

INTRODUCTION: In 2024, 30.4% of the German population had a migration background. People with migration-related language barriers face numerous challenges within the healthcare system, which can negatively impact their health outcomes. While language barriers affect healthcare in general, oncology represents a complex field in which effective communication is crucial. For people with cancer in particular, difficulties in understanding information, treatment options, and the healthcare system itself may hinder access to services. This increases the risk of complications, prolonged hospitalisations and readmissions. At the same time, there is little information about this group, and evaluations of structured services are lacking. This study assesses a nurse-led complex intervention focusing on structured information and ongoing support for people with cancer and migration-related language barriers. METHODS AND ANALYSIS: The intervention is designed for people with cancer and migration-related language barriers and comprises three key elements: (a) continuous guidance provided by already existing roles of oncology nurse specialists, (b) a telephone interpreting service and (c) multilingual informational materials. We will assess the intervention's effectiveness with a controlled before-and-after study. Assuming an effect size of d=0.5 and using a 2:1 allocation ratio with 80% power, we aim to recruit 126 people with cancer and migration-related language barriers (84 intervention; 42 control) for participation. We will assess the primary outcome psychosocial support needs assessed with the Psychosocial Risk Questionnaire (PSR) at admission, discharge, and 3-month post-discharge using paper-based or digital questionnaires. The secondary outcomes, such as knowledge, quality of life, anxiety and satisfaction, are measured alongside the primary outcomes and compare the distribution of items and scores using Student's t-test (total scores) or the Wilcoxon rank sum test (individual items) at a one-sided significance level of 5%. We will use an embedded process and economic evaluation to examine the feasibility, acceptability and implementation of the intervention in line with the Medical Research Council guidance for process evaluations of complex interventions. ETHICS AND DISSEMINATION: The Ethics Committee of the Faculty of Medicine, University of Cologne (No. 23-1303 and 24-1266), approved the protocol, and the study was registered in the German Clinical Trials Register. We will disseminate the results of the study through peer-reviewed publications and at academic conferences. TRIAL REGISTRATION NUMBER: German Clinical Trials Register (DRKS00034749).