Study design
COLONAV is a cluster randomized controlled trial conducted in 5 French Departments (districts). It assesses the effectiveness of a Patient Navigation Intervention among deprived populations. The study used a complex interventions evaluation methodology to assess the effectiveness of this intervention [The study was approved by an institutional review board (Ethical Committee of Saint Etienne University Hospital, 10In the framework of real world complex intervention evaluation [• Effectiveness for health outcomes was evaluated quantitatively through the cluster randomized control trial.• Context evaluation was performed quantitatively through the strata analysis alongside the trial and qualitatively through an ethnographic evaluation.